RADIANCE-HTN TRIO 6-Month Data Presented on Combined Effect of Medical Titration and RDN Treatment

November 4, 2021—The 6-month outcomes from the randomized RADIANCE-HTN TRIO trial comparing endovascular ultrasound renal denervation (RDN) to a sham procedure for treatment-resistant hypertension (HTN) found that the addition of a pharmacologic intervention led to further blood pressure reductions after RDN with a smaller increase in additional medications prescribed and less use of diuretics.

These findings were reported at TCT 2021, the 33rd annual Transcatheter Cardiovascular Therapeutics scientific symposium of the Cardiovascular Research Foundation held November 4-6 online and in Orlando, Florida. RADIANCE-HTN TRIO, which is funded by Recore Medical, Inc., is evaluating the company’s Paradise RDN system.

As noted in the TCT press release, patients with HTN require a multifaceted approach for blood pressure control.

According to TCT, the RADIANCE-HTN TRIO was composed of patients with daytime ambulatory systolic blood pressure (dASBP) 135/85 mg Hg despite a fixed-dose combination pill consisting of a calcium channel blocker, angiotensin receptor blocker, and thiazide diuretic. These patients were randomized to RDN (n = 69) or sham procedure (n = 67).

In May 2021, the study’s 2-month results were presented at ACC.21, the American College of Cardiology’s virtual 70th annual scientific sessions, and simultaneously published by Michel Azizi, MD, et al in The Lancet (2021;297:2476-2486). The 2-month data showed that, in conjunction with the three-drug fixed-dose combination pill, RDN reduced dASBP by an additional 8 mm Hg, which is a 4.5 mm Hg greater reduction compared with a sham procedure (–8.0 mm Hg vs –3.0 mm Hg; median between-group difference, –4.5 mm Hg; adjusted P = .022).

The TCT press release reported that during months 2 through 5, the addition of a standardized stepped-care antihypertensive treatment (SSAHT) was recommended sequentially with the addition of spironolactone 25 mg/d, bisoprolol 10 mg/d, full dose of a centrally acting α2 receptor agonist, and an α1 receptor blocker if monthly measured home blood pressure was ≥ 135/85 mm Hg, with the goal of achieving blood pressure control in both groups. Adherence to prescribed medications was similar in both groups (71% for RDN vs 78% for sham; P = .41).

The investigators reported that the increase in the number of antihypertensive medications at 6 months after the addition of the SSAHT was 0.7 ± 1.0 for RDN and 1.1 ± 1.1 for sham (P = .045). The use of aldosterone antagonists at 2 months was 3% for RDN and 11% for sham (P = .16). At 6 months, the number increased in both groups but to a lesser extent in the RDN group (40% for RDN vs 60.9% for sham; P = .017).

The RADIANCE-HTN TRIO study found that the addition of the stepped care antihypertensive regimen to the initially randomized therapy further decreased blood pressures in both arms. The overall change from baseline in dASBP was –11.8 ± 14.2 mm Hg in the RDN group versus 12.3 ± 14.2 mm Hg for the sham group (P = .65). Home blood pressure was lower in patients initially randomized to RDN when adjusted for baseline BP and number of medications (–4.28 mm Hg; P = .027). Safety outcomes were similar for both groups.

“Blood pressure reductions after RDN were achieved with a smaller increase in additional medications prescribed and less use of aldosterone antagonists compared with a sham procedure,” commented Ajay J. Kirtane, MD, in the TCT press release. “These results demonstrate the additional effects of pharmacologic intervention with maintenance of a BP-lowering effect of endovascular ultrasound RDN at 6 months.”

Dr. Kirtane is Professor of Medicine at the Columbia University Vagelos College of Physicians and Surgeons, Chief Academic Officer at Columbia University Interventional Cardiovascular Care, and Director at New-York-Presbyterian/Columbia University Irving Medical Center’s Cardiac Catheterization Laboratories in New York, New York.