Updates From Transcatheter Cardiovascular Therapeutics 2022
In this video, Michael J. Bloch, MD, speaks about updates from the Transcatheter Cardiovascular Therapeutics (TCT) 2022 conference, including the results from the RADIANCE II Pivotal Study: A Study of the ReCor Medical Paradise System in Stage II Hypertension and who could be the ideal candidate to consider for renal denervation.
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Michael J. Bloch, MD, is an associate professor at the University of Nevada School of Medicine, the medical director of vascular care at the Renown Institute for Heart and Vascular Health, and the President of Blue Spruce Medical Consultants, PLLC in Reno, Nevada.
Dr Michael J. Bloch: Hello, my name's Dr Michael Bloch. I'm a hypertension and vascular medicine specialist out of Reno, Nevada. And just wanted to briefly talk a little bit about some of the really exciting information that was presented at the TCT Meeting this last weekend in the field of renal denervation.
As a hypertension specialist, I've been interested in the field of renal denervation for over 10 years now. I will preface my comments by saying that I do have some relationships with the companies that are developing this technology. I work with ReCor. I've been an investigator for some of their trials. I've been a consultant for both ReCor and for Medtronic, who presented data at this meeting.
Unique from those potential conflicts, I think all of us interested in hypertension are going to find that this is a very interesting time that we're considering this investigational procedure. The, I think, biggest news out of TCT, at least in the field of hypertension, was the RADIANCE II study. The RADIANCE II study uses ReCor's ultrasound endovascular renal denervation device. This is now the third major study that we have seen with this device.
In RADIANCE II, there were 224 patients who had uncontrolled high blood pressure, both in and out of the office, who were randomized to either undergo renal denervation or a placebo procedure, a sham procedure, in two-to-one fashion. Patients were to remain off all antihypertensive medications for two months after having the procedure done. And then, the primary endpoint was 24-hour blood pressure reductions, daytime, 24-hour ambulatory blood pressure reductions at two months.
What we saw is that at two months, patients who were treated with the Paradise endovascular catheter ended up with a mean daytime that was 7.9-millimeters reduced from baseline, while those who were treated with sham had only a 1.8-millimeter reduction in their blood pressure, so a statistically significant and clinically meaningful 6 millimeters of ambulatory blood pressure reduction looking at the daytime. We also, as secondary endpoints, saw reductions at nighttime through the 24-hour period. And importantly, we know that ambulatory blood pressure monitoring is a great tool because it gets rid of the high white coat effect. It gives us lots of readings. But, importantly, we know that clinic and home readings are also important, and we use those all the time in clinical practice, and it did significantly reduce clinic, office, and home readings. And actually, from a millimeter to millimeter perspective, a little bit more in the office than with ambulatory.
So, as I mentioned, this is now the third study that we have seen, third major clinical trial presented at major meetings with this ultrasound endovascular device, all showing very consistent results. Two of the studies, RADIANCE II and RADIANCE SOLO, were in patients on no background medications. And then there was also the RADIANCE TRIO study, which was done with patients on a fixed dose of three other antihypertensives. All, as I say, have shown very consistent results.
So this remains an investigational procedure. We're going to be hopefully developing a continued access protocol where in some centers like ours in the country, we can continue to do some of these procedures. But our hope is that this will eventually find its way into routine clinical practice because we know that patients don't like to take their medicines. We know that many patients' blood pressure is not controlled, over 50% at this point. And when faced with the option of prescribing them another medication, many of those patients don't want to take another medicine.
And there's actually some pretty good preference studies out there that suggest when you give them that hypothetical scenario, your blood pressure's not controlled. We have this procedure that is safe and effective. Which would you rather do? Try this procedure or try and take another medicine? Many oftentimes, they say they would like to try the procedure. And that is one thing I should have mentioned about all three of these RADIANCE trials is that they've had great safety data. And the RADIANCE II that was just presented this weekend, no major safety events at 30 days.
So there also was some data that was presented on a different type of catheter for renal denervation, a radio frequency catheter that Medtronic makes. This was actually a very interesting data that was presented about a study they did years ago. This was with an older catheter. There was certainly design flaws with that original study and we really kind of think of that as the old days of renal denervation. Medtronic has since changed the way they use the catheter. They've changed how they do their clinical trials.
But even going back to the study that was done many years ago, the primary endpoint at that time was at six months. But they continued to follow patients, and in fact, many patients crossed over. They were originally randomized to sham and then crossed over to get denervation. And when they went and they looked at their three-year data, they found that patients who were denervated originally had lower blood pressures than those who remained not denervated.
I think there are some methodological issues with that type of study. It's not really a control group after all of those years, but when you look at the data in terms of where these patients ended up in terms of their blood pressure versus where they started in the actively treated group, I think there are emerging data that suggests that the procedure does offer durable results. So not just clinically meaningful results in the short term, but durable results in the long term, and I think we've seen that with both types of system, the ultrasound system and the radio frequency system.
So, I think we're really starting to get to the point where we're going to be thinking about who is the ideal candidate for us to consider for renal denervation. This is still probably some time off, probably a year off before any of these devices are commercialized. But I think as a community, it's important for us to start thinking about who we might want to denervate, who we might want to consider for this procedure.
There are some new guidelines that are going to be coming out. They were presented but have not yet been published from the ESC, European Society of Cardiology. But in this office, we also have a number of different papers that have come out, including a scientific statement from Sky and the National Kidney Foundation that really talked a little bit about what patients we may want to be considering when and if this becomes available.
What we considered in this panel was that we might want to look at renal denervation in patients who met all of the following criteria. They had persistent uncontrolled high blood pressure despite the prescription of guideline-based therapies. That is, they were treated but not controlled, that we had confirmation of poor control by out-of-office blood pressure, either ambulatory blood pressure monitoring or home blood pressure monitoring, that we'd excluded secondary cause. We thought it was important that these patients have higher cardiovascular risk, and that way, we may be getting more for our buck in terms of who we decide we're going to denervate, so high cardiovascular risk or established cardiovascular disease was important.
Also important was patient preference in shared decision-making. We've done, as I mentioned, a lot of patient preference modeling. And it certainly seems that there are some people who are really interested in this and some people who really aren't interested in this and would be happy to take another medicine, so patient preference is going to be key. Preferably we'd like to see endorsement by more than one provider with appropriate specialty background. And then, of course, we are going to need experienced interventionalists that are able to perform a procedure and really work together with somebody who's interested in the medical management of that patient's hypertension. So that it's not just a one-and-done type procedure, but we're going to be following these patients up for months to years, making sure that their blood pressure stays under good control.
So as I said, it's been quite a journey with renal denervation. Still, investigational, but some really strong data that came out this last weekend at TCT. Thank you very much for your attention