Ultrasound renal denervation lowers BP at 2 months vs. sham: RADIANCE II
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BOSTON — Compared with a sham procedure, ultrasound renal denervation lowered BP in patients with resistant hypertension at 2 months, according to results of the RADIANCE II randomized trial.
The researchers randomly assigned 224 patients on a 2:1 basis to receive ultrasound renal denervation (ReCor Medical) or a sham procedure. Ajay J. Kirtane, MD, SM, professor of medicine at Columbia University Vagelos College of Physicians and Surgeons and interventional cardiologist at NewYork-Presbyterian/Columbia University Irving Medical Center, presented the results at TCT 2022.
“The trial met both primary and secondary endpoints, showing statistically and clinically significant reductions in daytime blood pressure [and] 24-hour nighttime home and office blood pressure,” Kirtane said at a press conference.
All patients had uncontrolled hypertension with a history of treatment with zero to two antihypertensive medications, daytime BP off medication between 135 mm Hg and 170 mm Hg systolic and 85 mm Hg and 105 mm Hg diastolic, no prior CV or cerebrovascular events, no type 1 or uncontrolled type 2 diabetes, no severe renal dysfunction and suitable renal anatomy.
After enrollment, patients underwent a medication washout for 4 weeks, followed by CTA or MR angiography and then renal angiography, after which they underwent randomization if they remained eligible, Kirtane said at the press conference.
The primary efficacy endpoint was change in daytime ambulatory systolic BP at 2 months. Mean daytime ambulatory systolic BP at baseline was 150.3 mm Hg in the renal denervation group and 151.2 mm Hg in the sham group, Kirtane said.
At 2 months, daytime ambulatory systolic BP declined 7.9 mm Hg in the renal denervation group and 1.8 mm Hg in the sham group (between-group difference in means, –6.3 mm Hg; 95% CI, –9.3 to –3.2; P < .0001), Kirtane said.
He said that in the renal denervation group, patients were more likely to achieve control of daytime ambulatory systolic BP if they were closer to control at baseline (P for trend = .003), but that was not the case for the sham group (P for trend = .4).
Kirtane also noted that in the renal denervation group, the absolute change in daytime ambulatory systolic BP was greatest in patients farthest away from control at baseline (P for trend = .045).
“It’s important that where the patients actually start [affects] where their blood pressure is going to be,” Kirtane said at the press conference.
There were no major adverse events in either group at 30 days, and no evidence of new-onset renal artery stenosis in either group at 6 months, Kirtane said at the press conference.
The results are consistent with the previous studies RADIANCE-HTN SOLO, of patients with uncontrolled BP not on antihypertensive medication, and RADIANCE-HTN TRIO, in patients with triple-therapy-resistant hypertension, “confirming that ultrasound renal denervation lowers blood pressure across the spectrum of hypertension,” Kirtane said at the press conference.
“There are several things that I think we have learned from prior experience,” Kirtane said, referring to the failed clinical trials of early-generation renal denervation systems. “The catheter designs were iterated, and in addition, we learned a lot about trial design, ascertaining that we need to have a stable baseline, which is why [there was the washout period]. The biggest thing is to control the confounding effect of medications, because medications work well to lower blood pressure.”
Perspective
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Both RADIANCE II and SYMPLICITY HTN-3 have significant signals of transcatheter devices that work. With RADIANCE II, we need to delve into the medical therapies for the patients, as medical therapy also works at reducing BP. If achieving BP control means adding one more drug for someone who is already taking one or two drugs, and you can get the same reduction in BP as with renal denervation, then transcatheter treatment may not be needed. Dr. Kirtane appropriately discussed the essentials of lifestyle and drug therapy, and the renal denervation would be considered only when you have a patient who is not responding to drug therapy. There are a lot of drugs, and in most patients, they work.
The issue is whether the patients take their medications. For patients who are not adherent, we now have data on a procedure that may provide long-lasting effects. However, this could be problematic if some patients and clinicians want to move in that direction early. It is worth emphasizing that drug therapy has other advantages that you do not get from device therapy. For example, there are effects on the myocardium and on the systemic vasculature that can be cardioprotective. And can protect the kidneys, too. The long-term results of renal denervation trials will be interesting to see. If we can follow the results of optimal drug therapy of patients on the sham side, we can determine if drug therapy has benefits beyond just lowering BP.
There is some uncertainty as to where device therapy should fit in. Once these procedures are approved for treating hypertension, there is concern of inappropriate early use. We will have to see what the indications will be in terms of how many drugs are tried, and for how long, whether side effects from drugs are a reason to proceed with device therapy, etc. The medication history in the patients in this trial is going to be very important to examine.
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Kirtane AJ. Late-Breaking Clinical Science in Vascular Disease and Hypertension: Session III, in Collaboration With the Journal of the American Medical Association. Presented at: TCT Scientific Symposium; Sept. 16-19, 2022; Boston (hybrid meeting).
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