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Six-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.

Findings were reported today at TCT 2021, the 33^rd annual scientific symposium of the Cardiovascular Research Foundation (CRF). TCT is the world's premier educational meeting specializing in interventional cardiovascular medicine.

Patients with HTN require a multi-faceted approach for blood pressure control. In RADIANCE-HTN TRIO, 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, were randomized to RDN (n=69) or sham procedure (n=67). Presented at ACC 2021 and published in The Lancet, two-month results found that, in conjunction with the three-drug fixed-dose combination pill, RDN reduced dASBP by an additional 8 mm Hg, a 4.5 mm Hg greater reduction compared with a sham procedure (–8.0 mm Hg versus –3.0 mm Hg; median between-group difference –4.5 mm Hg; adjusted p=0.022).

During months two through five, buy generic orlistat ca no prescription 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 versus 78% for sham, p=0.41).

The increase in the number of anti-hypertensive medications at six months following the addition of the SSAHT was 0.7 ± 1.0 for RDN and 1.1 ± 1.1 for sham (p=0.045). The use of aldosterone antagonists at two months was 3% for RDN and 11% for sham (p=0.16). At six months, the number increased in both groups but to a lesser extent in the RDN group (40% for RDN compared to 60.9% for sham, p=0.017).

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 sham (p=0.65). Home blood pressure was lower in patients initially randomized to RDN when adjusted for baseline BP and number of medications (-4.28 mmHg, p=0.027). 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," said Ajay J Kirtane, MD, SM, 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 NewYork-Presbyterian/Columbia University Irving Medical Center's Cardiac Catheterization Laboratories. "These results demonstrate the additional effects of pharmacologic intervention with maintenance of a BP-lowering effect of endovascular ultrasound RDN at six months."