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BP-lowering effect of renal denervation persists at 6 months in RADIANCE-HTN SOLO
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NEW ORLEANS — Endovascular ultrasound renal denervation resulted in BP reductions that were maintained at 6 months, with fewer prescriptions for antihypertension medications needed, compared with a sham procedure in patients with uncontrolled hypertension, researchers reported at the American College of Cardiology Scientific Session.
Ajay Kirtane, MD, SM, presented 6-month data on 69 patients with uncontrolled combined systolic and diastolic hypertension who were assigned renal denervation with an ultrasound-based device (Paradise, ReCor Medical) and 71 patients assigned a sham procedure. The mean age in both arms was 54 years and most were men.
At 6 months, 62.5% of patients assigned renal denervation were treated with standardized stepped-care antihypertensive treatment vs. 84.5% of patients assigned sham control (P = .008. The renal denervation group was taking fewer antihypertensive medications at 6 months: 0.9 medications vs. 1.3 medications (P = .01). Moreover, the defined daily dose of antihypertensive medications was also lower with renal denervation: 1.4 vs. 2 (P = .018), Kirtane, chief academic officer at the Center for Interventional Vascular Therapy at Columbia University Medical Center, director of NewYork-Presbyterian and Columbia Catheterization Laboratories and Cardiology Today’s Intervention Editorial Board Member, said during the presentation.
Despite less intensive therapy, renal denervation lowered daytime ambulatory systolic BP to a greater extent than the sham procedure, according to the researchers. The mean reduction at 6 months was 18.1 mm Hg with renal denervation vs. 15.6 mm Hg with sham control (difference adjusted for baseline Bp and number of medications, 4.3 mm Hg; 95% CI, -7.9 to -0.6; P = .024).
From baseline to 6 months, more patients assigned renal denervation had decreases in daytime ambulatory BP greater than 10 mm Hg (78% vs. 62%; P = .036), greater than 15 mm Hg (62% vs. 45%; P= .041) and greater than 20 mm Hg (49% vs. 34%; P = .063) compared with those assigned sham procedure.
“One can appreciate that these significant drops in blood pressure that combined the additive effect of denervation plus medications are greater compared to medications alone,” Kirtane said during the presentation.
Rates of ambulatory, home and office BP control at 6 months were also greater with renal denervation.
No major adverse events occurred in either group through 6 months, according to the results.
The data were simultaneously published in Circulation.
Two-month results of the RADIANCE-HTN SOLO trial were previously reported in 146 patients assigned renal denervation or sham and a 4-week antihypertensive medication washout period. At 2 months, primary daytime ambulatory systolic BP was reduced by 8.5 mm Hg with renal denervation vs. 2.2 mm Hg with a sham procedure (6.3 mm Hg between-group difference; P < .0001).
“Taken together, the 2- and 6-month data demonstrate the efficacy of endovascular renal denervation both in the absence of medications at 2 months and then in the presence of medications at 6 months, especially when added back in a titrated fashion,” Kirtane said.
RADIANCE-HTN SOLO was conducted at 21 centers in the United States and 18 in Europe. The aim was to study the effect of renal denervation in patients with hypertension that had been controlled with one or two antihypertensive medications or uncontrolled with none to two medications, but for the purpose of this trial they were weaned off all medications. Follow-up was performed at 2 months to assess for the primary efficacy endpoint and mean daytime ambulatory BP while off medication. Other follow-up visits were conducted monthly up to 6 months to assess BP control, medication burden and home, office and ambulatory BP. A titrated protocol was initiated at the 2-month visit in both treatment groups to titrate antihypertensive medications if home BP monitoring resulted in an elevated reading.
“[This allowed us] to look at medication burden after patients had been basically reset off of all medications and subjected to the procedure,” Kirtane said during the presentation.
The Paradise endovascular ultrasound-based device “aims to circumferentially ablate renal nerves at a depth of 1 mm to 6 mm overall,” he said. “Because it is circumferential, there could be concern for luminal injury. This device in particular employs a cooling balloon to affect the thermal profile ... essentially preserving the lumen, but yet ablating nerves at a depth of 1 mm to 6 mm.”
“We feel that if corroborated by additional data from ongoing trials in this [RADIANCE] program, these data do suggest that endovascular ultrasound renal denervation may have a clinical role as an adjunctive therapy or even as alternative to starting or uptitrating antihypertensive medications in patients with uncontrolled systolic and diastolic blood pressure,” Kirtane said. – by Darlene Dobkowski, with additional reporting by Katie Kalvaitis
References:
Kirtane AJ. Highlighted Original Research: Interventional Cardiology and the Year in Review. Presented at: American College of Cardiology Scientific Session; March 16-18, 2019; New Orleans.
Azizi M, et al. Circulation. 2019;doi:10.1161/CIRCULATIONAHA.119.040451.
Disclosures: The study was funded by ReCor Medical. Kirtane reports he receives institutional funding to Columbia University and/or Cardiovascular Research Foundation from Abbott Vascular, Abiomed, Boston Scientific, CathWorks, Cardiovascular Systems Inc., Medtronic, Philips, ReCor Medical and Siemens. Azizi reports he received institutional research grant support from The French Federation of Cardiology, The French Ministry of Health, Idorsia, Novartis, Quantum Genomics, ReCor and Servier and honoraria from Actelion, Astra, CVRx, Idorsia, Novartis and Servier. Please see the study for all other authors’ relevant financial disclosures
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Chandan Devireddy, MD, FACC, FSCAI
This really went under the radar because it was presented at the same time as the PARTNER trial and the Evolut (Medtronic) low-risk trial. It is actually fascinating data. It is a small randomized controlled trial against a sham procedure, a level of evidence that we rarely see in CV trials.
The initial endpoint that had been reported was 2-month difference in BP and safety. That actually met their prespecified endpoints.
What happened from 2 months to 6 months is that all these patients were then allowed to be titrated on medications per the discretion of the treating physician, but with their treatment assignment still blinded. Providers did not know whether patients received denervation or if they were in the sham control group. They said, “Their blood pressure is this, I am either fine with what your blood pressure is if it is at pre-established guidelines.” If the patient was hypertensive, they said, “I am going to start you on these medications per a prespecified pathway of titration.”
What the study showed was that patients who had received renal denervation had a better ability to reach treatment guideline goals compared with patients in the sham procedure group.
There were some interesting bar graphs that they had. Comparing the renal denervation vs. the sham procedure group, in the patients who reached goal in both groups, there was a difference in how much medication they needed to get to that goal BP. It seems to be — and this has been suggested from these trials over the last year — that renal denervation is providing an effect that may be equivalent to adding another BP medicine but without having to take that medicine every day and all the issues that go along with compliance.
Medtronic reported some global Symplicity registry data. Given all of these trials, the FDA has greenlighted them for pivotal investigation, so that is something that we are anxiously waiting to see over the next year.
Next will be 12-month data, and some of the larger trials are hoping to finish enrollment this year. If we are lucky, we can see another late-breaking trial in the next 12 months.
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