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ACC 2020 Wrap-Up with Dr_ Valentin Fuster
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ACC 2020 Wrap-Up with Dr_ Valentin Fuster
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Language: EN.
Segment:0 .
Thank you to all for joining. I know these are challenging times, and we've had to adapt in ways that we hadn't imagined before. We're fortunate to have Dr. Fuster with us continuing this tradition of a wrap-up of a major cardiology meeting. Dr. Fuster is here to lead a discussion on the recent meeting of the American College of Cardiology. Dr. Fuster does not need much introduction, I will say he's Director of Mount Sinai Heart, Physician Chief of Mount Sinai Hospital, editor in Chief of the Journal of the American College of Cardiology, and Editor of Hurst's the Heart.
It's a privilege to be here virtually with Dr. Fuster today. We're very appreciative of the time, Dr. Fuster, that you're taking to do this and continuing the tradition that we have. I would ask that everyone on this call, please mute your phone. There will probably be time at the end for some questions and answers, and we are recording this, and this will be posted on a link that we will just distribute to you and others later today. Thank you, Dr. Fuster.
Well, thank you, Prashant, and thank you to everybody who is on the line. First of all, I wish all of you and your families and your friends to be healthy. I know that all of us have some people that we know that really have gone already through this disease, the coronavirus, but I think that we all think and pray for all of you.
So having said this, I like to make a summary of a very tense meeting a virtual meeting in the American College of Cardiology, the most important papers, and there were five sessions, so I chose two papers from each session, two presentations. Actually these are the 10 that have been downloaded most frequently in the last 24 hours. If I have time, I could comment to a few other studies, but let me focus into what I consider are the best 10 studies that were actually presented.
Segment:1 VICTORIA Trial (Vericiguat Global Study in Subjects With Heart Failure with Reduced Ejected Fraction).
Well, let me start with the first one, the so called VICTORIA Trial. VICTORIA Trial is entitled as it came in the New England Journal of Medicine, "Vericiguat in patients with heart failure and reduced ejection fraction." This was presented by Dr. Paul Armstrong from the University of Alberta in Edmonton, Canada, and it's a very interesting study, but before I mention the details, let me say that today inotropes are trying to address contractility of the heart by three different pathways.
The most important one is the part way of calcium entering into the myocardium. The second is enhancing the work of the infrastructure of the sarcomere. Finally, the third approach is the energy that is provided by the mitochondria. That third one is the one that this paper is all about. They're using a drug that I already mentioned, Vericiguat, which actually is a novel oral soluble guanylate cyclase stimulator that at the level of the mitochondria actually what it does is decreases oxidative stress, which actually is responsible for a decrease in nitric oxide in contributing to heart failure and vascular disease.
This drug, what it does is, it counteracts this process of oxidative stress and nitric oxide, so enhancing the nitric oxide activity. That's what it does. Well, this drug is interesting and was actually tested in people who actually had heart failure but were at a high risk. In fact, these were people with heart failure, patients with heart failure who actually had a deterioration, and then they were tested in a randomized study that I will mention.
This actually was a double-blind placebo-controlled randomized study, it was an international trial. The number of patients who entered into this study were about 5,000, and all had, as I mentioned, chronic heart failure. Ejection fraction had to be less than 45%, and the patients were then randomized into Vericiguat, with a target dose of 10 milligrams once daily, or placebo. The primary outcome was a composite of death from cardiovascular causes of first hospitalization for heart failure.
Follow-up about 10 months. Now, the primary outcome, and I repeat, which was the composite of death from cardiovascular causes in hospitalization for heart failure, occurred in 35% of the patients on Vericiguat. Versus 38% in the placebo group, so 3% difference. What about hospitalization for heart failure? 27% versus 29%.
What about death from cardiovascular causes? 16% versus 17%. And what about death from any cause or hospitalization for heart failure? 37% versus 40%. We are all moving between 2% and 3% difference. Symptomatic hypotension, 9% in the Vericiguat group, 7.9% in the placebo group.
And syncope was a little bit more also in the Vericiguat group, 4% versus 3.5% in the placebo group. So I quote now the conclusions as they're presented in the New England Journal of Medicine paper, and here it is, "Among patients with high-risk heart failure, the incidence of death from cardiovascular causes or hospitalization for heart failure was lower among those who received Vericiguat than among those who received placebo.
Well, this is the study, it was an interesting study, it's a new pathway in heart failure, another inotropic approach. And here, I had three questions actually. One is, are the results very significant? They are, but the question is the impact. We are moving from a 35 event rate to a 38 event rate, 35 event rate for the Vericiguat group, 38% for the group treated with placebo.
There's not a great difference, but we have already many, many studies on drugs that are being used today, that they begin having a very small difference, and then they resulted when they were used on specific groups of patients, they resulted having much more impact. So, to me, it's difficult to predict what is the future of Vericiguat when the difference between both groups that I presented is not so great.
The question is, can we identify perhaps patients at a significant risk with heart failure and maybe the impact will be more significant. This is really the question that is being addressed, but certainly is exciting how the field of heart failure is evolving with new pharmacological approaches and this is with a new inotrope, it appears to be efficacious. How impactful will it be in the future? This is the main question mark.
So, this is the first paper, we have 10 to go, so let's be, in a way, relaxed about it and go step by step, one by one.
Segment:2 VOYAGER PAD.
Here's the second paper. Second paper is the so called VOYAGER Pad, peripheral arterial disease. And the main title as it appeared in the New England Journal is, "Rivaroxaban in peripheral artery disease after revascularization." The paper was presented by Dr. Marc Bonaca who is from the University of Colorado in Aurora.
And this is actually the hypotheses, "It is well known that patients with peripheral arterial disease who undergo lower-extremity revascularization are at high risk for major adverse limb and cardiovascular events following the procedure." We have actually a couple of papers in JACC in the last few months that really get into these details. What is important now to really realize is that Aspirin has been used in these patients, Clopidogrel has been used, and oral anticoagulants have been used.
No difference as compared with nothing. So actually when we are talking about this group of patients with peripheral arterial disease that undergo revascularization, the role of antithrombotic agents has actually been very questionable. So here we come with the new oral agents, new oral anticoagulants, in this case it's Rivaroxaban. And here is the study, it was a double-blind trial of patients with peripheral arterial disease who had undergone acute revascularization, and I want to emphasize surgical or endovascular.
And they were randomized assigned to either Rivaroxaban 2.5 mg twice daily plus Aspirin or placebo plus Aspirin. The primary efficacy outcome was a composite of acute limb ischemia, major amputation for vascular causes, myocardial infarction, ischemic stroke, or death from cardiovascular causes. The principal safety outcome was major bleeding, addressed by the TIMI approach or the ISTH approach, the International Society on Thrombosis and Haemostasis.
We are talking about 6,500 patients who underwent randomization, and they were followed for a period of three years. What about the primary efficacy outcomes, all those variables that I mentioned a minute ago? Well, for the group treated with Rivaroxaban, 17% event rate at three years. For the group treated with placebo, 19.9%, so really 2% to 3% difference.
And the results were very significant. What about bleeding? Bleeding, there was not a very significant difference, perhaps more difference with the ISTH approach and with the TIMI approach. There is a difference between 0.5, 0.6% and 1%. So here we are with the conclusions of this paper, and again I quote the conclusions from the New England Journal of Medicine, "In patients with peripheral artery disease who had undergone lower-extremity revascularization, Rivaroxaban at a dose of 2.5 mg twice daily plus Aspirin was associated with a significantly lower incidence of the composite outcome of acute limb ischemia, et cetera." The incidence of major bleeding was very borderline using both criteria that I mentioned, the TIMI and the ISTH criteria.
So here we are again. How significant is this? In fact, two points of difference or 2% of difference between the group treated with Rivaroxaban and the group treated with placebo, and if we go into bleeding, it's about 1% difference. So is this going to have a significant impact? Again, I'm not entirely sure, but one thing I'm sure… that this is the first time that an antithrombotic agent works on these particular patients who have high risk peripheral arterial disease, who previously underwent revascularization.
And this means the issue actually of NOACs is fascinating. You know, it's beginning to work, this type of drug in atrial fibrillation, coronary artery disease, native disease, coronary artery disease following PCI or intervention. Now here we have peripheral vascular disease, as native atherosclerotic disease. So there's no question that these new oral antithrombotic agents are really having an impact, but the impact that we have in the paper today, published in JACC, I would say certainly is very significant, but the impact may be a little bit more than trivial, and we have to see how this works in the future.
So thank you for the second paper.
Segment:3 POPular TAVI (Antiplatelet therapy for patients undergoing trans catheter aortic valve implantation).
And now I'm going into the third one, This is an interesting one, actually, a very interesting one. This paper actually is called the POPular TAVI trial. So it is in patients who undergo TAVR, and actually they are most of them in atrial fibrillation.
The title is, "A Randomized Open-Label, Multicenter Study of Oral Anticoagulation with or without Clopidogrel after transcatheter aortic valve implantation." So the first author of this paper and actually the presenter of this paper was Dr. Vincent Nijenhuis from Saint Antonius Hospital in Nieuwegein in the Netherlands. And as I mentioned, is very interesting because we've covered today we have a lot of trouble what to do, and I will say that present scenario in terms of guidelines is you give dual antiplatelet therapy, but there are lots of questions, which should you give anticoagulants?
Remember the previously published Galileo trial, that's very recently, by Dr. Dangas et al. Anticoagulants alone didn't work when they were used with Aspirin. But anyway, let's focus into this study because still they are on anticoagulants, and let's see what happened. First of all, this is the problem, patients undergoing TAVR have a measured incidence of threatening bleeding from 3% to 15%, closer to the 5% range, and the incidence of a stroke is 1% to 8%, closer to 3–4%, but what happened if the patient is on atrial fibrillation?
Well, 30% of these patients have atrial fibrillation and certainly the risk of thromboembolic events is higher. Having said this, now let's go into the study that was presented in this recent meeting. Patients with atrial fibrillation that undergo TAVR, of course, they need oral anticoagulants, but at the same time-- this is to reduce stroke and thromboembolism, but at the same time, same patients need anti-platelet therapy because of the TAVR.
So would you say these could be an increase in bleeding? And this is where the study came from. Can we have an approximation to the best results with an antithrombotic approach that is still favorable in terms of ischemic events but does not induce bleeding? Very interesting. They use oral anticoagulants alone, and about 75% were vitamin K antagonist, and as I recall, 25% were new oral anticoagulant used alone versus oral anticoagulants plus three months of Clopidogrel.
And they have questions. What about bleeding? What about the composite endpoint of ischemia, stroke, myocardial infarction? And what about if it gives an endpoint you add everything, ischemic events and the bleeding events. So that's what this study was actually all about. Now I have to go into some detail. This is a European study in which the number of patients that participated actually was not large, 326 patients.
The average age-- Remember, these are patients with TAVR and were in atrial fibrillation, so not surprising. The average age was 81 years. And actually, number of male and female were practically the same. A unique study in this regard, I would say. Now, here we have the question. The 164 were randomized into oral anticoagulants alone, again, 75% vitamin K antagonist.
And the other group had oral auto-anticoagulants plus Clopidogrel for three months, 162 patients. I repeat, most of the patients had atrial fibrillation, actually 95%. And here comes the analysis and the follow-up. The follow-up is one year, and I will give the results in a minute, and obviously, we talk about ischemic events, we talk about bleeding in different forms and so forth that will be, I hope, clearly understood.
The first question that the trialists had was bleeding. And actually, in this regard, very good results. Oral anticoagulants alone, the amount of bleeding, 21% at one year, and the bleeding oral anticoagulants plus Clopidogrel at three months, 34%, so 21% to 34%. Very significant. And in this regard, we now have, let's use together mortality, bleeding, stroke, and myocardial infarction.
It's still significant, actually. We have 31% for the group with oral anticoagulants alone versus 45% in those in which we look at mortality, stroke, myocardial infarction, and actually also bleeding. So now comes, what about if we exclude bleeding here, and we just use mortality, ischemic stroke, and myocardial infarction?
I don't know how you can answer this question, but the oral anticoagulant alone did better, not significant though, did better than oral anticoagulants plus Clopidogrel. Just in ischemic events, 13% versus 17%. Don't tell me why. The number of patients was not large, and perhaps this is an issue of the statistics, but at least what is most important is actually the conclusions of the study.
These other patients even established indication for oral anticoagulants because they are on atrial fibrillation, and they undergo TAVR, and these are the results. Oral anticoagulants alone as compared to oral anticoagulants plus Clopidogrel for three months reduced the rate of bleeding events, including major life threatening or disabling bleeding, and there was no increase in the rate of thrombotic events. Then I think this is very interesting because we have TAVR, and we have been completely obsessed with the use of platelet inhibitor drugs, and then we have a recent study, Galileo study, in which the Rivaroxaban given plus Aspirin, which actually didn't work.
In fact, this study had to be discontinued. Well, this is what they get from all of these. Maybe an anticoagulant alone is the answer for patients undergoing TAVR. Who knows? And I agree, this should be the one of the next trials at least, is to use either a new oral anticoagulant or even anticoagulants alone in patients with TAVR without any touch of Aspirin or Clopidogrel.
That's the conclusion that I got from these studies, an interesting conclusion. And certainly, we'll see the future, what we have to use for patients undergoing TAVR. Here, the use of oral anticoagulants was an excuse. It's because the patients were on atrial fibrillation. Well, this being said,
Segment:4 PARTNER 3.
let me go into the fourth paper. Maybe in the meantime, I will have a glass of water.
I have to go get it, but anyway, let me try. This is the fourth study. This is an interesting study too. The PARTNER 3 trial. And this study is entitled "Two-Year Clinical and Echocardiographic Outcomes From the PARTNER 3 Low-Risk Randomized Trial." The investigators of this trial, the principal investigators, are Dr. Michael Mack and Dr. Martin Leon.
And now, let's go into the real issues. I'm going to read the background. I want to be sure that we are accurate on that, and then we'll move into this study. Let me read it. Previous PARTNER trials have shown that TAVR was superior to standard therapy in extreme risk patients and non-inferior surgery in high and intermediate risk patients with aortic stenosis.
Results from the PARTNER 3 trial recently presented in low-risk patients demonstrated superiority for TAVR versus surgery for the primary endpoint of death, stroke, or rehospitalization at one year. Remember that the main variable that was positive in favor of the TAVR was the rehospitalization. And this was actually at one year.
So what is being presented in this meeting is the two-year follow-up of everything I said. And actually, I'm going to go first into the number of patients that were randomized and so forth. Originally, 1,000 patients were randomized into TAVR, and I want to emphasize that this was the SAPIEN 3
?: surgery surgical bioprosthetic valve. The trend medium point was composite of all cause mortality, again, stroke or cardiovascular rehospitalization. And I already presented to you the results. The trial was positive. And so, the rehospitalization played a major role. So, this being said, I'm not going now to define the aortic stenosis of the patients that were excluded.
?: I think common sense will tell you this, but I'd like to present now the results in different ways. First, let me make a summary. At about two years of follow-up, basically the results are in parallel to what was found at one year of follow-up, with a little bit of a piece of the TAVR doing a little bit worse in that one-year compared with the surgical approach. For example, here we have the primary endpoint, as you recall, and this primary endpoint is practically the same.
?: The difference at one year was between 8.5% in the results in the TAVR group versus 15.6% in the surgical group. There was a 7% difference. Without going into the details, now the difference is 6%. TAVR, not so good, but still the results being significant. And now, I have different groups. What about death? Death alone at one year, 1% for TAVR, 2.5% for surgery.
?: The difference was 1.5%. Now it's 0.8%, a little bit more mortality in TAVR compared with surgery. What about stroke? The same. 1.2% for TAVR in one year, 3.3% for surgery at one year. But the difference at 24 months is 1.2%. Again, a little bit more stroke for TAVR, but the results are actually practically the same.
?: And now, rehospitalization. The same. And this is the main feature here. 7.3% at one year in the TAVR group, 11.3% in the surgical group, a 4% difference. At this time, the same. It's a 4% difference. How about thrombosis? A little bit more with TAVR again.
?: Very little in these two years of follow-up. So, what I'm really saying to you is that the results are in parallel really, but TAVR, perhaps not so good. What about echocardiographic results? Well, interesting, the mean gradient at one year and then two years, exactly the same. What about the aortic valve failure? Exactly the same. What about parabolic valve regurgitation?
?: Exactly the same. You know, it was in the TAVR group at one year, some degree of regurgitation occurred in about, let me see, 29% of patients. This was mild. And in the surgical group, was actually 2.1. 29% versus 2.1%. The same is actually at two years. So, now it's time to summarize the data.
?: And let me see, what I can say is here. The summary is the following, I quote the results. In a defined population of severe symptomatic aortic stenosis, patients who were at low surgical risk, TAVR with the SAPIEN approach compared to surgery at these two years demonstrated, first, reduced primary endpoint events. 37% reduction in death, stroke, or cardiovascular rehospitalization in the TAVR group as compared with the surgical group.
?: However, more death and stroke events in the TAVR patients, although these changes were not significant at two years. Importantly, there was a significant reduction of cardiovascular rehospitalization favoring TAVR at one year and at two years, this being the main variable favoring TAVR in this low surgical risk group of patients. So, I guess the question here is how far do we go?
?: Well, at least, what we can say is that if patients have severe aortic valve stenosis, and the patients in a way are at relatively low risk in terms of comorbidities and so forth, I think TAVR still can be considered. And the question is, we should be careful, however, if the patient is very young. The reason I'm saying this, because we didn't mention here the need for pacemakers and so forth, or perhaps the need of a new operation if you start using these in a very early age.
?: Surgery also can lead to a new operation. But the issue of pacemakers is important. So, what I take from this study, that TAVR is moving well in patients with severe aortic stenosis, even in those who are at a low risk in terms of comorbidities. But be careful in not being too cavalier here. And perhaps the issue of pacemakers that are needed in younger population when they use TAVR. If the incidence is high, certainly more than 10%, it should be considered.
?: Thank you. Now I'm going to be reviewing the paper number five. It's called PRONOMOS. And the title in the New England Journal of Medicine is "Rivaroxaban or Enoxaparin in non-major orthopedic surgery." Dr. Nadia Rosencher presented this paper, and Dr. Marc Samama is the first author of the paper. He's from Paris.
?: I think it's an interesting situation, but let me give a perspective. We all have guidelines of how to treat patients who undergo hip replacement or knee replacement. This is not what this paper is about. This paper goes into other procedures in the lower extremities, like fractures or some kind of knee surgery, Achilles tendon, whatever it is, in which the guidelines, the European guidelines and the American guidelines actually differ in terms of whether or not antithrombotication should be used, and if used, which one?
?: So these are questions here. And this is what this study is all about, is these non-major orthopedic surgical approaches, and see what to use. Well, this is an international randomized double-blind non-inferiority trial in which two groups of patients were randomized.
Segment:5 PRONOMOS (Rivaroxaban or Enoxaparin in Nonmajor Orthopedic Surgery).
?: All of them underwent lower limb nonmajor orthopedic surgery, as I mentioned, and they were considered to be at risk for venous thromboembolism in one way or another.
?: They received either Rivaroxaban for two weeks, 10 milligrams daily, or Enoxaparin, 40 milligrams subcutaneously. The primary efficacy outcome was major venous thromboembolism, and this was a composite of different things, symptomatic, distal, or proximal deep vein thrombosis, pulmonary embolism, etc. And the patients also could be asymptomatic with proximal deep vein thrombosis, and this also being part of the outcome.
?: Now, one of the important issues was safety, the safety issues in terms of major bleeding or non-major bleeding. The study took off in actually 3,500 patients, and they were in the randomization I mentioned. And here, the major venous thromboembolism occurred in 0.2% in the Rivaroxaban group, I'm talking about two weeks of follow-up, and in 1.1% in the Enoxaparin group.
?: So again, the results, they show almost nothing. But anyway, in terms of bleeding, again, from depending on the method used, from 0.6% to 1.1%, a little bit more bleeding in the Rivaroxaban group. Well, actually, practically the same. So, here we have a situation of these patients who undergo orthopedic surgery, non-major surgery, and the question is, should we use anything?
?: Well, frankly, I'm not sure after reading this paper. Certainly, again, Rivaroxaban turns out to be a winner. And maybe in other patients in which the risks are higher and we use Enoxaparin, maybe the possibility of thinking about Rivaroxaban, according to this paper, is an appropriate one. The paper has some limitations in terms of the many people enrolled into this study, and then we don't have follow-up data.
?: The duration of the antithrombotic therapy was not necessarily the same on everybody. But at least the message is, again, that Rivaroxaban and this type of new oral antithrombotic agent really are taking a protagonism in the whole field of cardiovascular diseases. And I think this is another example that we have that was presented in this meeting. Let's now move on to number six.
?: Those of you who are interested in the so-called
Segment:6 SPYRAL-HTN OFF MED.
?: catheter-based renal denervation, you can enjoy this paper. Actually, it's the SPYRAL Hypertension Off Medicine Pivotal Trial. The real title is "Catheter-Based Renal Denervation in the Absence of Antihypertensive Medications," and these are the primary results. Why? Because there was a pilot study before That was already said it was worth it to continue.
?: It was a pilot trial that was already published saying this is feasible, and maybe this procedure may be of some help in hypertensive patients. And here is the overall study at least in a follow-up, not too long as you will see in a moment, and we will continue in the future. Let me now define this study. These were patients, actually, hypertensive patients. I will tell you what blood pressure they were.
?: Office blood pressure, systolic equal or more than 150, and less than 180. Office, diastolic blood pressure equal or more than 90 millimeters of mercury. The systolic 24-hour mean ambulatory blood pressure, just take 10 millimeters off and your are there. Is in fact, is interesting. It was 10 millimeters less. The systolic pressure less than or equal to 140, and less than 170.
?: And then some patients were excluded. A GFR less than 45 milliliters per minute et cetera. This was a three month study. A study that is going to go for longer periods of time. What they looked at? Well, before I go into more detail into the specifics, let me tell you that, before I go into the endpoints, how many patients we are dealing with… are 300 patients.
?: And actually, these patients, what is interesting is they were not on medications. They were taken off medication, antihypertensive medications. And I think this is important. It's like a study in which this type of procedure is actually the only variable. They were followed for three months, and they looked at both office blood pressure and ambulatory blood pressure.
?: And at particularly the systolic blood pressure, this was the main focus. They looked at measured adverse events, thromboembolic organ failure, vascular complications, need of hospitalization because of hypertensive crises and so forth. So this is basically what was done. And here are the group of patients that enter into this study. 331, as mentioned.
?: Office blood pressure was 162 over 100, this was the average. Ambulatory blood pressure, 10 millimeters lower, 151 over 90. And then the average age of the patients, 52 years. 64% were male. 21% African Americans, as you know, it's one of the problems with hypertension. And then we have here the endpoint, change in 24 hours of systolic blood pressure for three months.
?: I think I mentioned this and the change in "The Office". So here I'm going to show you the results and see whether you are impressed, not impressed, you are excited or not excited. These are the results. 24 hours systolic blood pressure, it drops four millimeters of mercury. Diastolic blood pressure, three millimeters of mercury. What about office systolic blood pressure? Six millimeters of mercury drop by use of this final approach.
?: And diastolic blood pressure, again in the office, a drop of four millimeters. Here you can say who is an optimist, who is a pessimist, or whatever you can decide, just is a test. Well, I would say that actually I have to congratulate all these investigators. I really have to because this study using this approach, renal denervation, as you know, was down the tubes about three years ago.
?: And they decided to continue. And they persevered in this. And I think this, to me, is a very important congratulations. Now, how do you interpret the data? What this means? I am not sure. This is to be continued. But one thing is critically important. This approach decreases blood pressure.
?: How much? Not much, at least in the present situation. But we don't know, for people who are taking medications, it may be higher blood pressures, more resistant, how they are going to do. And this will come in the future. So I think that you can take these results, as I said, in a very positive way. You may be skeptical, maybe you will say this will never work in the future.
?: Frankly, I'm not sure. But I think what I'm sure is, the people who continue the trial have to be congratulated. This is what they mean by resilience. It's somebody who believes in something. And they believed that this would work, and it certainly does. Let's now move into, now we have number seven, paper number seven.
Segment:7 PRECOMBAT: Stenting vs. CABG for Left Main CAD.
?: Well, this is interesting. Everybody's talking about left main disease these days.
?: And here's the story. The PRECOMBAT study. The PRECOMBAT study, you might recall that certainly the interventionalists on the line . It started in Seoul, Korea, where it was the first study done for left main disease comparing stenting versus bypass surgery. Well, this is a full op of the regional results, which I will mention in a moment. And let me give you the title of this study… Ten-Year Outcomes After Drug Eluting Stents Versus Coronary Artery Bypass Grafting for Left Main Coronary Artery Disease." So you know it's a hot subject.
?: Let me tell you who entered into these studies. Well, first of all, it's has been a lot of conflict about left main bypass versus not, whether you're dealing with complex lesions versus non-complex lesions. There's a lot of discussion about it. But let's go into the bottom line. This, we are talking about 600 patients that had unprotected left main disease. And these patients had an average syntax score of 24, so they had disease in other arteries.
?: For example, 40% had three-vessel disease, 33% two-vessel disease, 16% one-vessel disease, in 9% only had left main. And you will say this is not a pure study. Well, it's a pure study because PCI versus CABG, all the lesions UNINTELLIGIBLE:, excluding the left main, were lesions easily addressed by either of both procedures. So in a way this answers the question.
?: These patients had ischemia by objective testing, or ischemic symptoms. And the patients were randomized. And this is important. In the PCI was the CYPHER stent. Remember, this is first generation, important to remember, versus CABG. This covered 300 patients. And then what we have here is the follow-up. The original follow-up was at five years, and now they move into 10 years.
?: Now, before we compare the results, let's say that the endpoint was the composite of that of any cause, myocardial infarction, a stroke or ischemia driven revascularization. I could stop talking about CPKs. More than that, I think you will forget about it. Let's say they did a very strict approach with the CPK, that I can say. And then let's move on.
?: Now, if you look at the results at five years, I could just summarize that what they had is a trend in favor of CABG. It was just a trend, not of statistical significance. So be sure that we don't lose sleep here saying that CABG is better. It was not, but it was a trend. Then what they decided to do is to move into 10 years. How they did with these patients, and this is amazing, I must say, very impressive.
?: They were able to follow them. A significant follow-up, very impressive and interesting. Obviously this is the system that they have there in Korea is everybody's covered by insurance and everything is registered, so it's easy to go there and find out what the adverse events had been, the mortality and so forth. And that, I think, is the beauty of this study.
?: Well, let's now go into the endpoints. And I want to be sure that the endpoints I clearly present to you before we discuss it. And I have here… it was a composite of death from any cause, myocardial infarction, stroke, or ischemic-driven target vessel revascularization. I mentioned this before, but I want to be sure. Results of this primary endpoint.
?: The same. Practically the same. CABG, 25%, 24.7. The PCI 29.8. No significance at all. It has a ratio of 1.25, but this is not significant. This is the primary endpoint. Then you exclude revascularization, and you say, let's exclude revascularization and see what happens.
?: Well, we're closer. 17.15% versus 18.2%. No difference between this first generation stents and CABG. That, no difference. Ischemic-driven target vessel revascularization, of course there was a difference. With PCI, 8%. On the CABG, 16% in the PCI. So, here what we have is the following situation.
?: We have the results of the study, which is the following. The PRECOMBAT was the first randomized controlled trial. This is very, very important because it's the first study that was done in looking at left main coronary artery disease. It's the first one. And basically what they say is, at 10 years of follow-up, there was no difference in the composite endpoint of that myocardial infarction, stroke or ischemic-driven revascularization by comparing CABG versus the first generation of stents.
?: Here is the way I see the situation. First of all, there's so much discussion about it. And I don't know, I had been in JACC, and seeing the papers coming in, and the controversies, and listening and so forth. This is what I take. If the patient is complex, then certainly I think CABG should be considered, and the distal main, and the bifurcations and so forth.
?: I think the patients we are talking about here are the patients who do not have complex left main disease. And finally, if you look at any type of data, and it seems both are very, very equal. In other words, what I'm saying is all the discussion about one procedure versus the other, frankly, I wonder if it's not more of an intellectual or academic discussion than a real one. So I don't see how things are going to change in the future.
?: What perhaps we need is longer follow-up, that's possible, and perhaps to categorize the lesions of the left main better. I don't know. This perhaps is the next step, but this is the way I see this particular trial or this particular study. Interesting. And this makes me to get into paper number eight.
Segment:8 Radial Artery Versus Saphenous Vein for Coronary Bypass Surgery Long Term Follow Up.
?: Well, this is the Radial Artery study. It's entitled "Radial Artery Versus Saphenous Vein For Coronary Artery Bypass Surgery at Long-Term Follow-Up".
?: So similar situation. In the short term, it was already published in the long-term. The author of this paper is Dr. Mario Gaudino from Cornell. And we have to go into the basic principles here. As you know, there's a lot of talk about arterial grafting in patients undergoing revascularization, surgical revascularization. But, there is not a lot of data of a long follow-up with the Radial Artery as compared only with saphenous vein grafts.
?: So let me present to you a patient. A patient comes to you with multi-vessel disease, and the right coronary artery and circumflex artery are involved. And then you say in one patient, I use the Radial Artery for one of these two, and the rest will be saphenous veins. And the other group will all be saphenous vein grafting. Okay. That's really the story. Well, the first reported original trials were actually five.
?: And this was interesting. These trials were from Serbia, Australia, United Kingdom, Italy, and South Korea. And the question was, who was the winner? And I think it's difficult to say, but it was a trend towards the Radial Artery being superior when it is used versus not being used. Another question is, what about 10 years? And here is another situation that is actually of interest, how these patients were followed.
?: What they did is the five groups participated, but the approach to the follow-up of the five different studies, that was a meta analysis originally, was done in different ways. With telephone, database, depending on the country et cetera. But this is actually what we are talking about. Over 500 patients with radial artery being involved. And 500 patients with saphenous vein graft in all the arteries. That's where we are.
?: The average age of the patient, 66 years. 70% male. Ejection fraction very normal, only 13% get an injection fraction that was below normal. LIMA was only in 8.5% of the patients. So we are really talking about the Radial Artery alone. Endpoints. That myocardial infarction, repeated revascularization, that and myocardial infarction, or that alone.
?: This is basically what it was. The median follow-up, as I mentioned, was 10 years. Results… The primary composite outcome, the Radial Artery is superior. And that is with a significant p-value. I should read the numbers to you, but I read the hazard ratio of 0.73 in favor of the Radial Artery approach. When you look at just myocardial infarction and death, practically the same.
?: When you look at death alone, interestingly it's also the same, Radial Artery superior, being significant. A hazard ratio of 0.73. And in terms of revascularization, actually the results are in favor also of the Radial Artery. That is to revascularize the patient again. So here we have the results. And that is… these are patients who undergo bypass surgery.
?: I think for most of them, it was an elective approach or stenting. And the patients, actually, what they did is they were-- Excuse me, stenting Radial Artery approach. And I think what the patients really show us is the Radial Artery is the superior. How much superior? Well, we obtain hazard ratios of 0.7 and so forth, so it was really better. Now comes the point, what this means?
?: What about when we talk about internal mammary arteries? Well, here there is some disconnection. Single internal mammary artery appears to be superior too, when it has been tested by the Cleveland Clinic and many others. And so what about two mammery arteries? Well, there is a trend in favor of patients doing better with dual mammary arteries than with one. We had a paper in JACC, I think a week ago, two weeks ago.
?: What about if you use Radial Artery, left internal mammary artery, and right mammary artery? What about that? Well, this has been done in some places, certainly in Australia with very good results, but there are no randomized studies. The thing that actually worries me is that, at least in the United States, only 15% of the surgeons use bilateral mammary arteries.
?: It's worrisome when it appears that the trend is to use both. Whether it's an issue of the technicalities that are involved, certainly is one possibility. The surgery takes longer is another possibility, but at least we should pay attention to the arterial grafting in patients undergoing bypass surgery. And here we have paper number nine. This is interesting, by the way, don't get frustrated,
Segment:9 E3: Evaluating the Efficacy of E-Cigarette Use for Smoking Cessation.
?: but interesting it is, it's about e-cigarettes.
?: This paper is called E3 Trial. And it's a randomized controlled trial evaluating the efficacy and safety of e-cigarettes for smoking cessation. The presenter was Dr. Mark Eisenberg, from McGill University. And let me now go into… I'm going to start from very primitive comments with the real results. The primitive comments on, of course, the long-term health effects of inhaling tobacco are well established.
?: We all agree with that. Even with use of pharmacological behavioral therapy, the thought is that more than two thirds of those attempting to quit returned to smoking within one year, second statement. The third statement is that many smokers now have adopted the use of e-cigarettes to quit. This is the paper that we are presenting today and was presented in this meeting, to use e-cigarettes to quit.
?: And finally the efficacy and safety of e-cigarettes for smoking cessation actually remains poorly delineated. And again, this is the paper I'm going to present. These are the objectives: to examine the efficacy and safety of nicotine and non-nicotine e-cigs–electronic cigarettes with individual counseling compared to counseling alone. Let me describe the groups because it's very important. Basically all the people who enterd into this study, most of them attempted to quit before, so we are already in a selective group that is trying very hard.
?: Well, we have the following groups, all of them, by the way, smoke at least 10 cigarettes a day. We have a first group, nicotine with the electronic cigarettes plus counseling. Follow-up,12 weeks. Second group, non-nicotine electronic cigarettes and counseling. Here there's no nicotine. As you know, nicotine is what makes you really adhere to the problem of cigarettes.
?: The second group is non-nicotine and they got counseling too. And the third is counseling alone. So each group was given these particular approaches. In each group are 128 patients or individuals. So what can I say? I can say Dr. Jagat Narula is going to smoke nicotine electronic cigarettes since he will be counseled for 12 weeks. Well, actually, in less time, but at 12 weeks, we're going to look at how Dr. Narula is doing.
?: By the way, he's not a smoker. And then we have Dr. Goldman, who is on non-nicotine electronic counseling and is not a smoker either. But both of them, according to the paper, have smoked before more than 10 cigarettes a day. And finally myself, I don't want to get into this business. I only want counseling. These are the three groups.
?: Let me tell you what happened because actually it is interesting. Let me tell you what happened at 12 weeks. First of all, how many of them had abstinence? That is that really didn't smoke at all or they really quit completely. 22% in the group with nicotine and electronic cigarettes and counseling.
?: 17% in the second group, the group of Dr. Goldman. And this is the group that smoked, but non-nicotine, and were counseled. And 9% in the counseling group, two. Do you know what I'm talking about? A complete failure, but let me go further. Maybe you are smoking one or two cigarettes, and you cannot say you are in abstinence, but let me give you the second piece of information.
?: Of those that were not on abstinence and were cigarette nicotine related-- electronic cigarettes plus counseling, the average smoking at 12 weeks was eight cigarettes, the second group, 10 cigarettes, and the third group, 14 cigarettes. I think this is what it is. I want to be sure that I'm telling you properly. No, excuse me, it's 8%, 10%, 14%.
?: Regardless, it's very bad. In other words, the results of this type of paper, which is beautifully done, by the way, is telling us that discontinuation of smoking is pretty difficult. And actually five people got some trouble during the trial, some events. And here are the conclusions by the authors. Nicotine e-cigs with individual counseling for 12 weeks may be efficacious for smoking cessation compared to counseling alone, non-nicotine e-cigs with individual counseling has benefits between those of nicotine e-cigs with counsel and counseling alone.
?: Few events to place and longer follow-up is necessary. Well, there are many ways to look at the paper. You can say it's true what they say, and that is that you can have counseling and then to have the e-cigarettes with nicotine or without nicotine and being successful. But really this is a very difficult task—to discontinue smoking. I have to congratulate the people of this paper.
?: It's beautifully done. It's a lot of information that they could go forward, but I think it's not necessary. It's just the message. We have to see what is the best mechanism to quit smoking. And these people have tried it before. Here's our last to study, which is fascinating, it's the ISCHEMIA Trial. We all know about the ISCHEMIA Trial.
Segment:10 CIAO ISCHEMIA.
?: What it actually was about. I will go into perhaps some preliminary information that is worth mentioning. In this ISCHEMIA Trial, there were a number of patients that actually had ischemia, moderate or severe, when they did the objective testing, as you know. And these people then underwent CT angiography. And from these people, there was a group that actually, they didn't find coronary artery disease at the time of doing the procedure when they did CT angiography.
?: And it's interesting, I'll tell you, it was 21% of people who entered into the ISCHEMIA Trial, that didn't have the disease despite of symptoms and objective evidence of ischemia. As you know, this is actually very prevalent in women, It has been described again and again and again. And even it's just been said that such situation called INOCA, Ischemia with No Obstructive Coronary Artery Disease, may actually affect close to 50% of women who present to us with ischemia or symptoms of ischemia.
?: And then you do a coronary angiogram and you find nothing. Two hypothesis. Hypothesis number one has been maybe epicardial coronary spasm. And hypotheses number two may be microvascular disease, the tiny vessels cannot dilate, it is an issue of reserve. It's not that they are spastic, they do not dilate. And actually the way to address this today, the cardiac catheterization laboratory is to do acetylcholine to assess the spastic phenomena of the epicardial arteries, and to use adenosine, to use the lack of dilation of the microvascular.
?: This is what is done in the laboratory, Well, let me now proceed into the study. The average age of the patients was actually 63, this is in the overall ISCHEMIA study. Women were 66%, and certainly in terms of the patients that we are describing that ended up with normal coronary arteries were 187 patients, 21%.
?: All had some ischemia on exercise testing and about 71% had symptoms suggestive of angina. And 49% had some shortness of breath. This is actually the patients that presented with INOCA in the study that I am relating. What is fascinating are the results. Very interesting. First observation, when they look at these patients with ischemia and angina pectoris, actually both were equal in those who had coronary anatomy or coronary artery disease and those who are INOCA.
?: In other words, when they look at how this stress test was, what about the intensity of the angina, no difference. So but one has repeatedly coronary disease and the others with out it. What about at the one year of follow-up? And this is actually the critical issue of this study. Change in ischemic segments, in 50% they normalized. So what was ischemia one day at 50%, normalized at one year.
?: And 45% were unchanged or actually worse. What about angina? Interesting. Better in 39% of the patients. Equal or worse in the remaining. The question is obviously the ischemic patients will be compared with the others and will be the same patients who have no angina or those who do not have ischema. Frustration, no relationship. So some patients had actually no angina at all anymore and they continue to have ischemic segments.
?: And some patients, no ischemic segments at all, and then, they have angina. What this is telling us… this is a functional disease. That's what we are talking about. And it depends when you talk to the patient, when you do what, that you're going to find the situation. Now, the interesting aspect is– at least that I can say to you, there were more women as expected than men, significantly more women. I don't have exactly the numbers here, but certainly this is a real syndrome that can be objectively quantified.
?: And the patients, many of them have angina, but the question is when you follow these patients medically, because that's what it was, these patients all received medications at one time or another, these are mixed up. You cannot tell who's getting better the ischemia and this may be less angina, that is not the case or maybe less angina… is no relationship. So I think what we are dealing here is with a functional syndrome probably related to microvasculature, I guess.
?: But this has to be tested in the future. It's a pity, of course, that these patients didn't undergo the appropriate testing to know exactly what they had. What I would do actually on this trial-- Actually, I was the other day to call the principal investigator and to say, "What I would do now, do noninvasive testing on these people who are actually normal coronary arteries and begin to address the issue of the functional problem".
?: And that is, to look at whether it could be the microvascular or the macrovascular, both aspects, as we mentioned. So this is actually the end of the story of the 10 papers that I had. I'd just like to finish by saying there were many interesting papers here that I didn't mention about, because really they follow concepts that were already established by the main investigators. Perhaps one paper to mention is the Taylor PCI paper, there is a lot of press about it.
?: And basically it has to do with Clopidogrel and the patients who are resistant because of the enzyme problem in the liver. Well, they found changing events in the first few weeks and in those that Clopidogrel was considered to be active versus those that were considered not to be active, and this was compared with ticagrelor, but at the end there was no difference with genetic testing. Another issue is Alirocumab and Evinacumab, they were tested in patients with familial homozygous hypercholesterolemia.
?: They result in terms of cholesterol dropping, LDL cholesterol levels, 30, 40 Mg/dL, excellent results. And in terms of side effects, there was a question about-- These patients who were followed for three to six months. There was a question about , but certainly the side effects were very trivial. And then there's this paper in REDUCE-IT with the paper using Icosapent—patients with hypertriglyceridemia.
?: This is now the follow-up of five years, and actually what they found is the same results as before, but perhaps they looked at two things. There was a reduction of 25% of cardiovascular events using icosapent, which as you know, is EPA that has been synthesized. And 30% total reduction of cardiovascular events. These were patients with high triglycerides, at high risk for coronary artery disease, but actually the results had nothing to do with the triglyceride levels and so forth.
?: So I finish here, and obviously the TWILIGHT trials and presentations were Roxana's group and Dr. Dangas and so forth. And what they found really validates very nicely the results that they had in different groups of patients. And this study in Seoul also with the monotherapy approach and using ticagrelor, with less bleeding, monotherapy after three months of the combination of ticagrelor and Aspirin, and they found the same results.
?: Thank you very much. I think it's been certainly a pleasure to go over all of these, and certainly this meeting, I would say, took place in a very awkward way, but I must say it was very successful. And I think the number of people who attended some sessions was actually 19,000, one way or another. So I think that at least we can get something of these, although it appears to be trivial in a time when we are all involved with so many problems right now.
?: I thought it was worth it to at least continue the educational programs. Thank you very much for your attention.
Segment:0 .
Thank you to all for joining. I know these are challenging times, and we've had to adapt in ways that we hadn't imagined before. We're fortunate to have Dr. Fuster with us continuing this tradition of a wrap-up of a major cardiology meeting. Dr. Fuster is here to lead a discussion on the recent meeting of the American College of Cardiology. Dr. Fuster does not need much introduction, I will say he's Director of Mount Sinai Heart, Physician Chief of Mount Sinai Hospital, editor in Chief of the Journal of the American College of Cardiology, and Editor of Hurst's the Heart.
It's a privilege to be here virtually with Dr. Fuster today. We're very appreciative of the time, Dr. Fuster, that you're taking to do this and continuing the tradition that we have. I would ask that everyone on this call, please mute your phone. There will probably be time at the end for some questions and answers, and we are recording this, and this will be posted on a link that we will just distribute to you and others later today. Thank you, Dr. Fuster.
Well, thank you, Prashant, and thank you to everybody who is on the line. First of all, I wish all of you and your families and your friends to be healthy. I know that all of us have some people that we know that really have gone already through this disease, the coronavirus, but I think that we all think and pray for all of you.
So having said this, I like to make a summary of a very tense meeting a virtual meeting in the American College of Cardiology, the most important papers, and there were five sessions, so I chose two papers from each session, two presentations. Actually these are the 10 that have been downloaded most frequently in the last 24 hours. If I have time, I could comment to a few other studies, but let me focus into what I consider are the best 10 studies that were actually presented.
Segment:1 VICTORIA Trial (Vericiguat Global Study in Subjects With Heart Failure with Reduced Ejected Fraction).
Well, let me start with the first one, the so called VICTORIA Trial. VICTORIA Trial is entitled as it came in the New England Journal of Medicine, "Vericiguat in patients with heart failure and reduced ejection fraction." This was presented by Dr. Paul Armstrong from the University of Alberta in Edmonton, Canada, and it's a very interesting study, but before I mention the details, let me say that today inotropes are trying to address contractility of the heart by three different pathways.
The most important one is the part way of calcium entering into the myocardium. The second is enhancing the work of the infrastructure of the sarcomere. Finally, the third approach is the energy that is provided by the mitochondria. That third one is the one that this paper is all about. They're using a drug that I already mentioned, Vericiguat, which actually is a novel oral soluble guanylate cyclase stimulator that at the level of the mitochondria actually what it does is decreases oxidative stress, which actually is responsible for a decrease in nitric oxide in contributing to heart failure and vascular disease.
This drug, what it does is, it counteracts this process of oxidative stress and nitric oxide, so enhancing the nitric oxide activity. That's what it does. Well, this drug is interesting and was actually tested in people who actually had heart failure but were at a high risk. In fact, these were people with heart failure, patients with heart failure who actually had a deterioration, and then they were tested in a randomized study that I will mention.
This actually was a double-blind placebo-controlled randomized study, it was an international trial. The number of patients who entered into this study were about 5,000, and all had, as I mentioned, chronic heart failure. Ejection fraction had to be less than 45%, and the patients were then randomized into Vericiguat, with a target dose of 10 milligrams once daily, or placebo. The primary outcome was a composite of death from cardiovascular causes of first hospitalization for heart failure.
Follow-up about 10 months. Now, the primary outcome, and I repeat, which was the composite of death from cardiovascular causes in hospitalization for heart failure, occurred in 35% of the patients on Vericiguat. Versus 38% in the placebo group, so 3% difference. What about hospitalization for heart failure? 27% versus 29%.
What about death from cardiovascular causes? 16% versus 17%. And what about death from any cause or hospitalization for heart failure? 37% versus 40%. We are all moving between 2% and 3% difference. Symptomatic hypotension, 9% in the Vericiguat group, 7.9% in the placebo group.
And syncope was a little bit more also in the Vericiguat group, 4% versus 3.5% in the placebo group. So I quote now the conclusions as they're presented in the New England Journal of Medicine paper, and here it is, "Among patients with high-risk heart failure, the incidence of death from cardiovascular causes or hospitalization for heart failure was lower among those who received Vericiguat than among those who received placebo.
Well, this is the study, it was an interesting study, it's a new pathway in heart failure, another inotropic approach. And here, I had three questions actually. One is, are the results very significant? They are, but the question is the impact. We are moving from a 35 event rate to a 38 event rate, 35 event rate for the Vericiguat group, 38% for the group treated with placebo.
There's not a great difference, but we have already many, many studies on drugs that are being used today, that they begin having a very small difference, and then they resulted when they were used on specific groups of patients, they resulted having much more impact. So, to me, it's difficult to predict what is the future of Vericiguat when the difference between both groups that I presented is not so great.
The question is, can we identify perhaps patients at a significant risk with heart failure and maybe the impact will be more significant. This is really the question that is being addressed, but certainly is exciting how the field of heart failure is evolving with new pharmacological approaches and this is with a new inotrope, it appears to be efficacious. How impactful will it be in the future? This is the main question mark.
So, this is the first paper, we have 10 to go, so let's be, in a way, relaxed about it and go step by step, one by one.
Segment:2 VOYAGER PAD.
Here's the second paper. Second paper is the so called VOYAGER Pad, peripheral arterial disease. And the main title as it appeared in the New England Journal is, "Rivaroxaban in peripheral artery disease after revascularization." The paper was presented by Dr. Marc Bonaca who is from the University of Colorado in Aurora.
And this is actually the hypotheses, "It is well known that patients with peripheral arterial disease who undergo lower-extremity revascularization are at high risk for major adverse limb and cardiovascular events following the procedure." We have actually a couple of papers in JACC in the last few months that really get into these details. What is important now to really realize is that Aspirin has been used in these patients, Clopidogrel has been used, and oral anticoagulants have been used.
No difference as compared with nothing. So actually when we are talking about this group of patients with peripheral arterial disease that undergo revascularization, the role of antithrombotic agents has actually been very questionable. So here we come with the new oral agents, new oral anticoagulants, in this case it's Rivaroxaban. And here is the study, it was a double-blind trial of patients with peripheral arterial disease who had undergone acute revascularization, and I want to emphasize surgical or endovascular.
And they were randomized assigned to either Rivaroxaban 2.5 mg twice daily plus Aspirin or placebo plus Aspirin. The primary efficacy outcome was a composite of acute limb ischemia, major amputation for vascular causes, myocardial infarction, ischemic stroke, or death from cardiovascular causes. The principal safety outcome was major bleeding, addressed by the TIMI approach or the ISTH approach, the International Society on Thrombosis and Haemostasis.
We are talking about 6,500 patients who underwent randomization, and they were followed for a period of three years. What about the primary efficacy outcomes, all those variables that I mentioned a minute ago? Well, for the group treated with Rivaroxaban, 17% event rate at three years. For the group treated with placebo, 19.9%, so really 2% to 3% difference.
And the results were very significant. What about bleeding? Bleeding, there was not a very significant difference, perhaps more difference with the ISTH approach and with the TIMI approach. There is a difference between 0.5, 0.6% and 1%. So here we are with the conclusions of this paper, and again I quote the conclusions from the New England Journal of Medicine, "In patients with peripheral artery disease who had undergone lower-extremity revascularization, Rivaroxaban at a dose of 2.5 mg twice daily plus Aspirin was associated with a significantly lower incidence of the composite outcome of acute limb ischemia, et cetera." The incidence of major bleeding was very borderline using both criteria that I mentioned, the TIMI and the ISTH criteria.
So here we are again. How significant is this? In fact, two points of difference or 2% of difference between the group treated with Rivaroxaban and the group treated with placebo, and if we go into bleeding, it's about 1% difference. So is this going to have a significant impact? Again, I'm not entirely sure, but one thing I'm sure… that this is the first time that an antithrombotic agent works on these particular patients who have high risk peripheral arterial disease, who previously underwent revascularization.
And this means the issue actually of NOACs is fascinating. You know, it's beginning to work, this type of drug in atrial fibrillation, coronary artery disease, native disease, coronary artery disease following PCI or intervention. Now here we have peripheral vascular disease, as native atherosclerotic disease. So there's no question that these new oral antithrombotic agents are really having an impact, but the impact that we have in the paper today, published in JACC, I would say certainly is very significant, but the impact may be a little bit more than trivial, and we have to see how this works in the future.
So thank you for the second paper.
Segment:3 POPular TAVI (Antiplatelet therapy for patients undergoing trans catheter aortic valve implantation).
And now I'm going into the third one, This is an interesting one, actually, a very interesting one. This paper actually is called the POPular TAVI trial. So it is in patients who undergo TAVR, and actually they are most of them in atrial fibrillation.
The title is, "A Randomized Open-Label, Multicenter Study of Oral Anticoagulation with or without Clopidogrel after transcatheter aortic valve implantation." So the first author of this paper and actually the presenter of this paper was Dr. Vincent Nijenhuis from Saint Antonius Hospital in Nieuwegein in the Netherlands. And as I mentioned, is very interesting because we've covered today we have a lot of trouble what to do, and I will say that present scenario in terms of guidelines is you give dual antiplatelet therapy, but there are lots of questions, which should you give anticoagulants?
Remember the previously published Galileo trial, that's very recently, by Dr. Dangas et al. Anticoagulants alone didn't work when they were used with Aspirin. But anyway, let's focus into this study because still they are on anticoagulants, and let's see what happened. First of all, this is the problem, patients undergoing TAVR have a measured incidence of threatening bleeding from 3% to 15%, closer to the 5% range, and the incidence of a stroke is 1% to 8%, closer to 3–4%, but what happened if the patient is on atrial fibrillation?
Well, 30% of these patients have atrial fibrillation and certainly the risk of thromboembolic events is higher. Having said this, now let's go into the study that was presented in this recent meeting. Patients with atrial fibrillation that undergo TAVR, of course, they need oral anticoagulants, but at the same time-- this is to reduce stroke and thromboembolism, but at the same time, same patients need anti-platelet therapy because of the TAVR.
So would you say these could be an increase in bleeding? And this is where the study came from. Can we have an approximation to the best results with an antithrombotic approach that is still favorable in terms of ischemic events but does not induce bleeding? Very interesting. They use oral anticoagulants alone, and about 75% were vitamin K antagonist, and as I recall, 25% were new oral anticoagulant used alone versus oral anticoagulants plus three months of Clopidogrel.
And they have questions. What about bleeding? What about the composite endpoint of ischemia, stroke, myocardial infarction? And what about if it gives an endpoint you add everything, ischemic events and the bleeding events. So that's what this study was actually all about. Now I have to go into some detail. This is a European study in which the number of patients that participated actually was not large, 326 patients.
The average age-- Remember, these are patients with TAVR and were in atrial fibrillation, so not surprising. The average age was 81 years. And actually, number of male and female were practically the same. A unique study in this regard, I would say. Now, here we have the question. The 164 were randomized into oral anticoagulants alone, again, 75% vitamin K antagonist.
And the other group had oral auto-anticoagulants plus Clopidogrel for three months, 162 patients. I repeat, most of the patients had atrial fibrillation, actually 95%. And here comes the analysis and the follow-up. The follow-up is one year, and I will give the results in a minute, and obviously, we talk about ischemic events, we talk about bleeding in different forms and so forth that will be, I hope, clearly understood.
The first question that the trialists had was bleeding. And actually, in this regard, very good results. Oral anticoagulants alone, the amount of bleeding, 21% at one year, and the bleeding oral anticoagulants plus Clopidogrel at three months, 34%, so 21% to 34%. Very significant. And in this regard, we now have, let's use together mortality, bleeding, stroke, and myocardial infarction.
It's still significant, actually. We have 31% for the group with oral anticoagulants alone versus 45% in those in which we look at mortality, stroke, myocardial infarction, and actually also bleeding. So now comes, what about if we exclude bleeding here, and we just use mortality, ischemic stroke, and myocardial infarction?
I don't know how you can answer this question, but the oral anticoagulant alone did better, not significant though, did better than oral anticoagulants plus Clopidogrel. Just in ischemic events, 13% versus 17%. Don't tell me why. The number of patients was not large, and perhaps this is an issue of the statistics, but at least what is most important is actually the conclusions of the study.
These other patients even established indication for oral anticoagulants because they are on atrial fibrillation, and they undergo TAVR, and these are the results. Oral anticoagulants alone as compared to oral anticoagulants plus Clopidogrel for three months reduced the rate of bleeding events, including major life threatening or disabling bleeding, and there was no increase in the rate of thrombotic events. Then I think this is very interesting because we have TAVR, and we have been completely obsessed with the use of platelet inhibitor drugs, and then we have a recent study, Galileo study, in which the Rivaroxaban given plus Aspirin, which actually didn't work.
In fact, this study had to be discontinued. Well, this is what they get from all of these. Maybe an anticoagulant alone is the answer for patients undergoing TAVR. Who knows? And I agree, this should be the one of the next trials at least, is to use either a new oral anticoagulant or even anticoagulants alone in patients with TAVR without any touch of Aspirin or Clopidogrel.
That's the conclusion that I got from these studies, an interesting conclusion. And certainly, we'll see the future, what we have to use for patients undergoing TAVR. Here, the use of oral anticoagulants was an excuse. It's because the patients were on atrial fibrillation. Well, this being said,
Segment:4 PARTNER 3.
let me go into the fourth paper. Maybe in the meantime, I will have a glass of water.
I have to go get it, but anyway, let me try. This is the fourth study. This is an interesting study too. The PARTNER 3 trial. And this study is entitled "Two-Year Clinical and Echocardiographic Outcomes From the PARTNER 3 Low-Risk Randomized Trial." The investigators of this trial, the principal investigators, are Dr. Michael Mack and Dr. Martin Leon.
And now, let's go into the real issues. I'm going to read the background. I want to be sure that we are accurate on that, and then we'll move into this study. Let me read it. Previous PARTNER trials have shown that TAVR was superior to standard therapy in extreme risk patients and non-inferior surgery in high and intermediate risk patients with aortic stenosis.
Results from the PARTNER 3 trial recently presented in low-risk patients demonstrated superiority for TAVR versus surgery for the primary endpoint of death, stroke, or rehospitalization at one year. Remember that the main variable that was positive in favor of the TAVR was the rehospitalization. And this was actually at one year.
So what is being presented in this meeting is the two-year follow-up of everything I said. And actually, I'm going to go first into the number of patients that were randomized and so forth. Originally, 1,000 patients were randomized into TAVR, and I want to emphasize that this was the SAPIEN 3
?: surgery surgical bioprosthetic valve. The trend medium point was composite of all cause mortality, again, stroke or cardiovascular rehospitalization. And I already presented to you the results. The trial was positive. And so, the rehospitalization played a major role. So, this being said, I'm not going now to define the aortic stenosis of the patients that were excluded.
?: I think common sense will tell you this, but I'd like to present now the results in different ways. First, let me make a summary. At about two years of follow-up, basically the results are in parallel to what was found at one year of follow-up, with a little bit of a piece of the TAVR doing a little bit worse in that one-year compared with the surgical approach. For example, here we have the primary endpoint, as you recall, and this primary endpoint is practically the same.
?: The difference at one year was between 8.5% in the results in the TAVR group versus 15.6% in the surgical group. There was a 7% difference. Without going into the details, now the difference is 6%. TAVR, not so good, but still the results being significant. And now, I have different groups. What about death? Death alone at one year, 1% for TAVR, 2.5% for surgery.
?: The difference was 1.5%. Now it's 0.8%, a little bit more mortality in TAVR compared with surgery. What about stroke? The same. 1.2% for TAVR in one year, 3.3% for surgery at one year. But the difference at 24 months is 1.2%. Again, a little bit more stroke for TAVR, but the results are actually practically the same.
?: And now, rehospitalization. The same. And this is the main feature here. 7.3% at one year in the TAVR group, 11.3% in the surgical group, a 4% difference. At this time, the same. It's a 4% difference. How about thrombosis? A little bit more with TAVR again.
?: Very little in these two years of follow-up. So, what I'm really saying to you is that the results are in parallel really, but TAVR, perhaps not so good. What about echocardiographic results? Well, interesting, the mean gradient at one year and then two years, exactly the same. What about the aortic valve failure? Exactly the same. What about parabolic valve regurgitation?
?: Exactly the same. You know, it was in the TAVR group at one year, some degree of regurgitation occurred in about, let me see, 29% of patients. This was mild. And in the surgical group, was actually 2.1. 29% versus 2.1%. The same is actually at two years. So, now it's time to summarize the data.
?: And let me see, what I can say is here. The summary is the following, I quote the results. In a defined population of severe symptomatic aortic stenosis, patients who were at low surgical risk, TAVR with the SAPIEN approach compared to surgery at these two years demonstrated, first, reduced primary endpoint events. 37% reduction in death, stroke, or cardiovascular rehospitalization in the TAVR group as compared with the surgical group.
?: However, more death and stroke events in the TAVR patients, although these changes were not significant at two years. Importantly, there was a significant reduction of cardiovascular rehospitalization favoring TAVR at one year and at two years, this being the main variable favoring TAVR in this low surgical risk group of patients. So, I guess the question here is how far do we go?
?: Well, at least, what we can say is that if patients have severe aortic valve stenosis, and the patients in a way are at relatively low risk in terms of comorbidities and so forth, I think TAVR still can be considered. And the question is, we should be careful, however, if the patient is very young. The reason I'm saying this, because we didn't mention here the need for pacemakers and so forth, or perhaps the need of a new operation if you start using these in a very early age.
?: Surgery also can lead to a new operation. But the issue of pacemakers is important. So, what I take from this study, that TAVR is moving well in patients with severe aortic stenosis, even in those who are at a low risk in terms of comorbidities. But be careful in not being too cavalier here. And perhaps the issue of pacemakers that are needed in younger population when they use TAVR. If the incidence is high, certainly more than 10%, it should be considered.
?: Thank you. Now I'm going to be reviewing the paper number five. It's called PRONOMOS. And the title in the New England Journal of Medicine is "Rivaroxaban or Enoxaparin in non-major orthopedic surgery." Dr. Nadia Rosencher presented this paper, and Dr. Marc Samama is the first author of the paper. He's from Paris.
?: I think it's an interesting situation, but let me give a perspective. We all have guidelines of how to treat patients who undergo hip replacement or knee replacement. This is not what this paper is about. This paper goes into other procedures in the lower extremities, like fractures or some kind of knee surgery, Achilles tendon, whatever it is, in which the guidelines, the European guidelines and the American guidelines actually differ in terms of whether or not antithrombotication should be used, and if used, which one?
?: So these are questions here. And this is what this study is all about, is these non-major orthopedic surgical approaches, and see what to use. Well, this is an international randomized double-blind non-inferiority trial in which two groups of patients were randomized.
Segment:5 PRONOMOS (Rivaroxaban or Enoxaparin in Nonmajor Orthopedic Surgery).
?: All of them underwent lower limb nonmajor orthopedic surgery, as I mentioned, and they were considered to be at risk for venous thromboembolism in one way or another.
?: They received either Rivaroxaban for two weeks, 10 milligrams daily, or Enoxaparin, 40 milligrams subcutaneously. The primary efficacy outcome was major venous thromboembolism, and this was a composite of different things, symptomatic, distal, or proximal deep vein thrombosis, pulmonary embolism, etc. And the patients also could be asymptomatic with proximal deep vein thrombosis, and this also being part of the outcome.
?: Now, one of the important issues was safety, the safety issues in terms of major bleeding or non-major bleeding. The study took off in actually 3,500 patients, and they were in the randomization I mentioned. And here, the major venous thromboembolism occurred in 0.2% in the Rivaroxaban group, I'm talking about two weeks of follow-up, and in 1.1% in the Enoxaparin group.
?: So again, the results, they show almost nothing. But anyway, in terms of bleeding, again, from depending on the method used, from 0.6% to 1.1%, a little bit more bleeding in the Rivaroxaban group. Well, actually, practically the same. So, here we have a situation of these patients who undergo orthopedic surgery, non-major surgery, and the question is, should we use anything?
?: Well, frankly, I'm not sure after reading this paper. Certainly, again, Rivaroxaban turns out to be a winner. And maybe in other patients in which the risks are higher and we use Enoxaparin, maybe the possibility of thinking about Rivaroxaban, according to this paper, is an appropriate one. The paper has some limitations in terms of the many people enrolled into this study, and then we don't have follow-up data.
?: The duration of the antithrombotic therapy was not necessarily the same on everybody. But at least the message is, again, that Rivaroxaban and this type of new oral antithrombotic agent really are taking a protagonism in the whole field of cardiovascular diseases. And I think this is another example that we have that was presented in this meeting. Let's now move on to number six.
?: Those of you who are interested in the so-called
Segment:6 SPYRAL-HTN OFF MED.
?: catheter-based renal denervation, you can enjoy this paper. Actually, it's the SPYRAL Hypertension Off Medicine Pivotal Trial. The real title is "Catheter-Based Renal Denervation in the Absence of Antihypertensive Medications," and these are the primary results. Why? Because there was a pilot study before That was already said it was worth it to continue.
?: It was a pilot trial that was already published saying this is feasible, and maybe this procedure may be of some help in hypertensive patients. And here is the overall study at least in a follow-up, not too long as you will see in a moment, and we will continue in the future. Let me now define this study. These were patients, actually, hypertensive patients. I will tell you what blood pressure they were.
?: Office blood pressure, systolic equal or more than 150, and less than 180. Office, diastolic blood pressure equal or more than 90 millimeters of mercury. The systolic 24-hour mean ambulatory blood pressure, just take 10 millimeters off and your are there. Is in fact, is interesting. It was 10 millimeters less. The systolic pressure less than or equal to 140, and less than 170.
?: And then some patients were excluded. A GFR less than 45 milliliters per minute et cetera. This was a three month study. A study that is going to go for longer periods of time. What they looked at? Well, before I go into more detail into the specifics, let me tell you that, before I go into the endpoints, how many patients we are dealing with… are 300 patients.
?: And actually, these patients, what is interesting is they were not on medications. They were taken off medication, antihypertensive medications. And I think this is important. It's like a study in which this type of procedure is actually the only variable. They were followed for three months, and they looked at both office blood pressure and ambulatory blood pressure.
?: And at particularly the systolic blood pressure, this was the main focus. They looked at measured adverse events, thromboembolic organ failure, vascular complications, need of hospitalization because of hypertensive crises and so forth. So this is basically what was done. And here are the group of patients that enter into this study. 331, as mentioned.
?: Office blood pressure was 162 over 100, this was the average. Ambulatory blood pressure, 10 millimeters lower, 151 over 90. And then the average age of the patients, 52 years. 64% were male. 21% African Americans, as you know, it's one of the problems with hypertension. And then we have here the endpoint, change in 24 hours of systolic blood pressure for three months.
?: I think I mentioned this and the change in "The Office". So here I'm going to show you the results and see whether you are impressed, not impressed, you are excited or not excited. These are the results. 24 hours systolic blood pressure, it drops four millimeters of mercury. Diastolic blood pressure, three millimeters of mercury. What about office systolic blood pressure? Six millimeters of mercury drop by use of this final approach.
?: And diastolic blood pressure, again in the office, a drop of four millimeters. Here you can say who is an optimist, who is a pessimist, or whatever you can decide, just is a test. Well, I would say that actually I have to congratulate all these investigators. I really have to because this study using this approach, renal denervation, as you know, was down the tubes about three years ago.
?: And they decided to continue. And they persevered in this. And I think this, to me, is a very important congratulations. Now, how do you interpret the data? What this means? I am not sure. This is to be continued. But one thing is critically important. This approach decreases blood pressure.
?: How much? Not much, at least in the present situation. But we don't know, for people who are taking medications, it may be higher blood pressures, more resistant, how they are going to do. And this will come in the future. So I think that you can take these results, as I said, in a very positive way. You may be skeptical, maybe you will say this will never work in the future.
?: Frankly, I'm not sure. But I think what I'm sure is, the people who continue the trial have to be congratulated. This is what they mean by resilience. It's somebody who believes in something. And they believed that this would work, and it certainly does. Let's now move into, now we have number seven, paper number seven.
Segment:7 PRECOMBAT: Stenting vs. CABG for Left Main CAD.
?: Well, this is interesting. Everybody's talking about left main disease these days.
?: And here's the story. The PRECOMBAT study. The PRECOMBAT study, you might recall that certainly the interventionalists on the line . It started in Seoul, Korea, where it was the first study done for left main disease comparing stenting versus bypass surgery. Well, this is a full op of the regional results, which I will mention in a moment. And let me give you the title of this study… Ten-Year Outcomes After Drug Eluting Stents Versus Coronary Artery Bypass Grafting for Left Main Coronary Artery Disease." So you know it's a hot subject.
?: Let me tell you who entered into these studies. Well, first of all, it's has been a lot of conflict about left main bypass versus not, whether you're dealing with complex lesions versus non-complex lesions. There's a lot of discussion about it. But let's go into the bottom line. This, we are talking about 600 patients that had unprotected left main disease. And these patients had an average syntax score of 24, so they had disease in other arteries.
?: For example, 40% had three-vessel disease, 33% two-vessel disease, 16% one-vessel disease, in 9% only had left main. And you will say this is not a pure study. Well, it's a pure study because PCI versus CABG, all the lesions UNINTELLIGIBLE:, excluding the left main, were lesions easily addressed by either of both procedures. So in a way this answers the question.
?: These patients had ischemia by objective testing, or ischemic symptoms. And the patients were randomized. And this is important. In the PCI was the CYPHER stent. Remember, this is first generation, important to remember, versus CABG. This covered 300 patients. And then what we have here is the follow-up. The original follow-up was at five years, and now they move into 10 years.
?: Now, before we compare the results, let's say that the endpoint was the composite of that of any cause, myocardial infarction, a stroke or ischemia driven revascularization. I could stop talking about CPKs. More than that, I think you will forget about it. Let's say they did a very strict approach with the CPK, that I can say. And then let's move on.
?: Now, if you look at the results at five years, I could just summarize that what they had is a trend in favor of CABG. It was just a trend, not of statistical significance. So be sure that we don't lose sleep here saying that CABG is better. It was not, but it was a trend. Then what they decided to do is to move into 10 years. How they did with these patients, and this is amazing, I must say, very impressive.
?: They were able to follow them. A significant follow-up, very impressive and interesting. Obviously this is the system that they have there in Korea is everybody's covered by insurance and everything is registered, so it's easy to go there and find out what the adverse events had been, the mortality and so forth. And that, I think, is the beauty of this study.
?: Well, let's now go into the endpoints. And I want to be sure that the endpoints I clearly present to you before we discuss it. And I have here… it was a composite of death from any cause, myocardial infarction, stroke, or ischemic-driven target vessel revascularization. I mentioned this before, but I want to be sure. Results of this primary endpoint.
?: The same. Practically the same. CABG, 25%, 24.7. The PCI 29.8. No significance at all. It has a ratio of 1.25, but this is not significant. This is the primary endpoint. Then you exclude revascularization, and you say, let's exclude revascularization and see what happens.
?: Well, we're closer. 17.15% versus 18.2%. No difference between this first generation stents and CABG. That, no difference. Ischemic-driven target vessel revascularization, of course there was a difference. With PCI, 8%. On the CABG, 16% in the PCI. So, here what we have is the following situation.
?: We have the results of the study, which is the following. The PRECOMBAT was the first randomized controlled trial. This is very, very important because it's the first study that was done in looking at left main coronary artery disease. It's the first one. And basically what they say is, at 10 years of follow-up, there was no difference in the composite endpoint of that myocardial infarction, stroke or ischemic-driven revascularization by comparing CABG versus the first generation of stents.
?: Here is the way I see the situation. First of all, there's so much discussion about it. And I don't know, I had been in JACC, and seeing the papers coming in, and the controversies, and listening and so forth. This is what I take. If the patient is complex, then certainly I think CABG should be considered, and the distal main, and the bifurcations and so forth.
?: I think the patients we are talking about here are the patients who do not have complex left main disease. And finally, if you look at any type of data, and it seems both are very, very equal. In other words, what I'm saying is all the discussion about one procedure versus the other, frankly, I wonder if it's not more of an intellectual or academic discussion than a real one. So I don't see how things are going to change in the future.
?: What perhaps we need is longer follow-up, that's possible, and perhaps to categorize the lesions of the left main better. I don't know. This perhaps is the next step, but this is the way I see this particular trial or this particular study. Interesting. And this makes me to get into paper number eight.
Segment:8 Radial Artery Versus Saphenous Vein for Coronary Bypass Surgery Long Term Follow Up.
?: Well, this is the Radial Artery study. It's entitled "Radial Artery Versus Saphenous Vein For Coronary Artery Bypass Surgery at Long-Term Follow-Up".
?: So similar situation. In the short term, it was already published in the long-term. The author of this paper is Dr. Mario Gaudino from Cornell. And we have to go into the basic principles here. As you know, there's a lot of talk about arterial grafting in patients undergoing revascularization, surgical revascularization. But, there is not a lot of data of a long follow-up with the Radial Artery as compared only with saphenous vein grafts.
?: So let me present to you a patient. A patient comes to you with multi-vessel disease, and the right coronary artery and circumflex artery are involved. And then you say in one patient, I use the Radial Artery for one of these two, and the rest will be saphenous veins. And the other group will all be saphenous vein grafting. Okay. That's really the story. Well, the first reported original trials were actually five.
?: And this was interesting. These trials were from Serbia, Australia, United Kingdom, Italy, and South Korea. And the question was, who was the winner? And I think it's difficult to say, but it was a trend towards the Radial Artery being superior when it is used versus not being used. Another question is, what about 10 years? And here is another situation that is actually of interest, how these patients were followed.
?: What they did is the five groups participated, but the approach to the follow-up of the five different studies, that was a meta analysis originally, was done in different ways. With telephone, database, depending on the country et cetera. But this is actually what we are talking about. Over 500 patients with radial artery being involved. And 500 patients with saphenous vein graft in all the arteries. That's where we are.
?: The average age of the patient, 66 years. 70% male. Ejection fraction very normal, only 13% get an injection fraction that was below normal. LIMA was only in 8.5% of the patients. So we are really talking about the Radial Artery alone. Endpoints. That myocardial infarction, repeated revascularization, that and myocardial infarction, or that alone.
?: This is basically what it was. The median follow-up, as I mentioned, was 10 years. Results… The primary composite outcome, the Radial Artery is superior. And that is with a significant p-value. I should read the numbers to you, but I read the hazard ratio of 0.73 in favor of the Radial Artery approach. When you look at just myocardial infarction and death, practically the same.
?: When you look at death alone, interestingly it's also the same, Radial Artery superior, being significant. A hazard ratio of 0.73. And in terms of revascularization, actually the results are in favor also of the Radial Artery. That is to revascularize the patient again. So here we have the results. And that is… these are patients who undergo bypass surgery.
?: I think for most of them, it was an elective approach or stenting. And the patients, actually, what they did is they were-- Excuse me, stenting Radial Artery approach. And I think what the patients really show us is the Radial Artery is the superior. How much superior? Well, we obtain hazard ratios of 0.7 and so forth, so it was really better. Now comes the point, what this means?
?: What about when we talk about internal mammary arteries? Well, here there is some disconnection. Single internal mammary artery appears to be superior too, when it has been tested by the Cleveland Clinic and many others. And so what about two mammery arteries? Well, there is a trend in favor of patients doing better with dual mammary arteries than with one. We had a paper in JACC, I think a week ago, two weeks ago.
?: What about if you use Radial Artery, left internal mammary artery, and right mammary artery? What about that? Well, this has been done in some places, certainly in Australia with very good results, but there are no randomized studies. The thing that actually worries me is that, at least in the United States, only 15% of the surgeons use bilateral mammary arteries.
?: It's worrisome when it appears that the trend is to use both. Whether it's an issue of the technicalities that are involved, certainly is one possibility. The surgery takes longer is another possibility, but at least we should pay attention to the arterial grafting in patients undergoing bypass surgery. And here we have paper number nine. This is interesting, by the way, don't get frustrated,
Segment:9 E3: Evaluating the Efficacy of E-Cigarette Use for Smoking Cessation.
?: but interesting it is, it's about e-cigarettes.
?: This paper is called E3 Trial. And it's a randomized controlled trial evaluating the efficacy and safety of e-cigarettes for smoking cessation. The presenter was Dr. Mark Eisenberg, from McGill University. And let me now go into… I'm going to start from very primitive comments with the real results. The primitive comments on, of course, the long-term health effects of inhaling tobacco are well established.
?: We all agree with that. Even with use of pharmacological behavioral therapy, the thought is that more than two thirds of those attempting to quit returned to smoking within one year, second statement. The third statement is that many smokers now have adopted the use of e-cigarettes to quit. This is the paper that we are presenting today and was presented in this meeting, to use e-cigarettes to quit.
?: And finally the efficacy and safety of e-cigarettes for smoking cessation actually remains poorly delineated. And again, this is the paper I'm going to present. These are the objectives: to examine the efficacy and safety of nicotine and non-nicotine e-cigs–electronic cigarettes with individual counseling compared to counseling alone. Let me describe the groups because it's very important. Basically all the people who enterd into this study, most of them attempted to quit before, so we are already in a selective group that is trying very hard.
?: Well, we have the following groups, all of them, by the way, smoke at least 10 cigarettes a day. We have a first group, nicotine with the electronic cigarettes plus counseling. Follow-up,12 weeks. Second group, non-nicotine electronic cigarettes and counseling. Here there's no nicotine. As you know, nicotine is what makes you really adhere to the problem of cigarettes.
?: The second group is non-nicotine and they got counseling too. And the third is counseling alone. So each group was given these particular approaches. In each group are 128 patients or individuals. So what can I say? I can say Dr. Jagat Narula is going to smoke nicotine electronic cigarettes since he will be counseled for 12 weeks. Well, actually, in less time, but at 12 weeks, we're going to look at how Dr. Narula is doing.
?: By the way, he's not a smoker. And then we have Dr. Goldman, who is on non-nicotine electronic counseling and is not a smoker either. But both of them, according to the paper, have smoked before more than 10 cigarettes a day. And finally myself, I don't want to get into this business. I only want counseling. These are the three groups.
?: Let me tell you what happened because actually it is interesting. Let me tell you what happened at 12 weeks. First of all, how many of them had abstinence? That is that really didn't smoke at all or they really quit completely. 22% in the group with nicotine and electronic cigarettes and counseling.
?: 17% in the second group, the group of Dr. Goldman. And this is the group that smoked, but non-nicotine, and were counseled. And 9% in the counseling group, two. Do you know what I'm talking about? A complete failure, but let me go further. Maybe you are smoking one or two cigarettes, and you cannot say you are in abstinence, but let me give you the second piece of information.
?: Of those that were not on abstinence and were cigarette nicotine related-- electronic cigarettes plus counseling, the average smoking at 12 weeks was eight cigarettes, the second group, 10 cigarettes, and the third group, 14 cigarettes. I think this is what it is. I want to be sure that I'm telling you properly. No, excuse me, it's 8%, 10%, 14%.
?: Regardless, it's very bad. In other words, the results of this type of paper, which is beautifully done, by the way, is telling us that discontinuation of smoking is pretty difficult. And actually five people got some trouble during the trial, some events. And here are the conclusions by the authors. Nicotine e-cigs with individual counseling for 12 weeks may be efficacious for smoking cessation compared to counseling alone, non-nicotine e-cigs with individual counseling has benefits between those of nicotine e-cigs with counsel and counseling alone.
?: Few events to place and longer follow-up is necessary. Well, there are many ways to look at the paper. You can say it's true what they say, and that is that you can have counseling and then to have the e-cigarettes with nicotine or without nicotine and being successful. But really this is a very difficult task—to discontinue smoking. I have to congratulate the people of this paper.
?: It's beautifully done. It's a lot of information that they could go forward, but I think it's not necessary. It's just the message. We have to see what is the best mechanism to quit smoking. And these people have tried it before. Here's our last to study, which is fascinating, it's the ISCHEMIA Trial. We all know about the ISCHEMIA Trial.
Segment:10 CIAO ISCHEMIA.
?: What it actually was about. I will go into perhaps some preliminary information that is worth mentioning. In this ISCHEMIA Trial, there were a number of patients that actually had ischemia, moderate or severe, when they did the objective testing, as you know. And these people then underwent CT angiography. And from these people, there was a group that actually, they didn't find coronary artery disease at the time of doing the procedure when they did CT angiography.
?: And it's interesting, I'll tell you, it was 21% of people who entered into the ISCHEMIA Trial, that didn't have the disease despite of symptoms and objective evidence of ischemia. As you know, this is actually very prevalent in women, It has been described again and again and again. And even it's just been said that such situation called INOCA, Ischemia with No Obstructive Coronary Artery Disease, may actually affect close to 50% of women who present to us with ischemia or symptoms of ischemia.
?: And then you do a coronary angiogram and you find nothing. Two hypothesis. Hypothesis number one has been maybe epicardial coronary spasm. And hypotheses number two may be microvascular disease, the tiny vessels cannot dilate, it is an issue of reserve. It's not that they are spastic, they do not dilate. And actually the way to address this today, the cardiac catheterization laboratory is to do acetylcholine to assess the spastic phenomena of the epicardial arteries, and to use adenosine, to use the lack of dilation of the microvascular.
?: This is what is done in the laboratory, Well, let me now proceed into the study. The average age of the patients was actually 63, this is in the overall ISCHEMIA study. Women were 66%, and certainly in terms of the patients that we are describing that ended up with normal coronary arteries were 187 patients, 21%.
?: All had some ischemia on exercise testing and about 71% had symptoms suggestive of angina. And 49% had some shortness of breath. This is actually the patients that presented with INOCA in the study that I am relating. What is fascinating are the results. Very interesting. First observation, when they look at these patients with ischemia and angina pectoris, actually both were equal in those who had coronary anatomy or coronary artery disease and those who are INOCA.
?: In other words, when they look at how this stress test was, what about the intensity of the angina, no difference. So but one has repeatedly coronary disease and the others with out it. What about at the one year of follow-up? And this is actually the critical issue of this study. Change in ischemic segments, in 50% they normalized. So what was ischemia one day at 50%, normalized at one year.
?: And 45% were unchanged or actually worse. What about angina? Interesting. Better in 39% of the patients. Equal or worse in the remaining. The question is obviously the ischemic patients will be compared with the others and will be the same patients who have no angina or those who do not have ischema. Frustration, no relationship. So some patients had actually no angina at all anymore and they continue to have ischemic segments.
?: And some patients, no ischemic segments at all, and then, they have angina. What this is telling us… this is a functional disease. That's what we are talking about. And it depends when you talk to the patient, when you do what, that you're going to find the situation. Now, the interesting aspect is– at least that I can say to you, there were more women as expected than men, significantly more women. I don't have exactly the numbers here, but certainly this is a real syndrome that can be objectively quantified.
?: And the patients, many of them have angina, but the question is when you follow these patients medically, because that's what it was, these patients all received medications at one time or another, these are mixed up. You cannot tell who's getting better the ischemia and this may be less angina, that is not the case or maybe less angina… is no relationship. So I think what we are dealing here is with a functional syndrome probably related to microvasculature, I guess.
?: But this has to be tested in the future. It's a pity, of course, that these patients didn't undergo the appropriate testing to know exactly what they had. What I would do actually on this trial-- Actually, I was the other day to call the principal investigator and to say, "What I would do now, do noninvasive testing on these people who are actually normal coronary arteries and begin to address the issue of the functional problem".
?: And that is, to look at whether it could be the microvascular or the macrovascular, both aspects, as we mentioned. So this is actually the end of the story of the 10 papers that I had. I'd just like to finish by saying there were many interesting papers here that I didn't mention about, because really they follow concepts that were already established by the main investigators. Perhaps one paper to mention is the Taylor PCI paper, there is a lot of press about it.
?: And basically it has to do with Clopidogrel and the patients who are resistant because of the enzyme problem in the liver. Well, they found changing events in the first few weeks and in those that Clopidogrel was considered to be active versus those that were considered not to be active, and this was compared with ticagrelor, but at the end there was no difference with genetic testing. Another issue is Alirocumab and Evinacumab, they were tested in patients with familial homozygous hypercholesterolemia.
?: They result in terms of cholesterol dropping, LDL cholesterol levels, 30, 40 Mg/dL, excellent results. And in terms of side effects, there was a question about-- These patients who were followed for three to six months. There was a question about , but certainly the side effects were very trivial. And then there's this paper in REDUCE-IT with the paper using Icosapent—patients with hypertriglyceridemia.
?: This is now the follow-up of five years, and actually what they found is the same results as before, but perhaps they looked at two things. There was a reduction of 25% of cardiovascular events using icosapent, which as you know, is EPA that has been synthesized. And 30% total reduction of cardiovascular events. These were patients with high triglycerides, at high risk for coronary artery disease, but actually the results had nothing to do with the triglyceride levels and so forth.
?: So I finish here, and obviously the TWILIGHT trials and presentations were Roxana's group and Dr. Dangas and so forth. And what they found really validates very nicely the results that they had in different groups of patients. And this study in Seoul also with the monotherapy approach and using ticagrelor, with less bleeding, monotherapy after three months of the combination of ticagrelor and Aspirin, and they found the same results.
?: Thank you very much. I think it's been certainly a pleasure to go over all of these, and certainly this meeting, I would say, took place in a very awkward way, but I must say it was very successful. And I think the number of people who attended some sessions was actually 19,000, one way or another. So I think that at least we can get something of these, although it appears to be trivial in a time when we are all involved with so many problems right now.
?: I thought it was worth it to at least continue the educational programs. Thank you very much for your attention.
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