Name:
RDN and the SPYRAL-HTN OFF MED Trial
Description:
RDN and the SPYRAL-HTN OFF MED Trial
Thumbnail URL:
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Duration:
T00H04M10S
Embed URL:
https://stream.cadmore.media/player/5cbfede6-d875-4ddf-a475-8b2609cc068a
Content URL:
https://cadmoreoriginalmedia.blob.core.windows.net/5cbfede6-d875-4ddf-a475-8b2609cc068a/18777597.mp3?sv=2019-02-02&sr=c&sig=NWCWBBoNBPxZkYc5hve3wuCFaZGGIffeaXj3UAIkGyg%3D&st=2024-12-22T06%3A12%3A58Z&se=2024-12-22T08%3A17%3A58Z&sp=r
Upload Date:
2022-02-28T00:00:00.0000000
Transcript:
Language: EN.
Segment:0 .
>> Practice Impact Extra podcasts are derived from Hurst's The Heart Board Review and other online resources available only through accesscardiology.com. >> As most people are aware, hypertension's prevalence is quite high in the United States. I think it'd be great to review whether or not renal artery denervation can offer some help in trying to establish better control in hypertension.
Hi, Dr. Bernie, and welcome to Practice Impact Extra. SYMPLICITY was a trial published in 2014 and was a blinded trial that did not -- did not show a significant reduction in blood pressure after renal artery denervation. However, recently, I've seen several additional trials that have reported some positive results after renal artery denervation. At the American College of Cardiology scientific meetings in 2020, a pivotal trial using aggressive catheter ablation -- and that's aggressive catheter ablation for renal denervation was presented, and that was the SPYRAL HTN-OFF MED trial.
The goal of this trial was to evaluate the Spyral catheter for renal artery denervation and compare that with a sham procedure among patients off medication with uncontrolled hypertension. I thought this was really an impressive trial design. The study randomized 331 patients with office systolic blood pressure between 150, but less than 180, and a diastolic pressure greater than 90. They also measured mean ambulatory blood pressure of greater than 140, but less than 170.
None of these patients were on anti-hypertensive meds upon randomization. So, what was the primary co pro -- so, what were the co-primary outcomes at 3 months? Office blood pressure systolic declined by 9.2 millimeters in the renal denervation group compared to 2.5 in the sham group. Office diastolic blood pressure reduced 5.1 millimeters, and that was lower than the renal artery group that was denervated, compared to 1 millimeter of mercury lowering in the sham group.
The mean blood pressure was reduced 4.7 in the renal denervation group and only 0.6 in the sham group. The same for diastolic pressure, which was lowered to 3.7 in the renal denervation group compared to 0.8 millimeters of mercury in the sham group. If you looked at the data in detail and reviewed it, you could see that several patients in the sham group began taking anti-hypertensive medication before the trial was completed.
And so, I think the differences would have even been greater than what I just -- the co-primary outcomes I listed before. So, really, what did this trial teach us? The results show us that renal artery denervation worked. It's an effective alternative compared to the sham procedure with a significant reduction in both systolic and diastolic blood pressure. The Spyral catheter that was used in this trial is pending FDA approval here in the United States.
I want you to stay tuned for a companion study that will be reported in the future, and that's testing the safety and effectiveness of renal artery denervation in patients taking up to three antihypertensive medications. Again, thanks for joining me, and see you next time on Practice Impact Extra. >> We hope you enjoyed this podcast from McGraw-Hill. Subscribers to AccessCardiology have instant access to over 25,000 pages of rich medical content, receive medical updates from trusted experts, and have access to other special features.
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