Renal denervation with a percutaneous bipolar radiofrequency balloon catheter in patients with resistant hypertension: 6-month results from the REDUCE-HTN clinical study.

Abstract

Aims: To evaluate the safety and efficacy of the balloon-based bipolar Vessix Renal Denervation System in treating patients with resistant hypertension. Methods and Results: In this prospective, multicentre, single-arm study, 146 patients (age 58.6+/-10.5 years; 61% men) with office systolic blood pressure (BP) >=160 mmHg despite >=3 antihypertensive medications at maximally tolerated doses were treated with the Vessix System. Efficacy endpoints were reductions in office and 24-hour ambulatory systolic and diastolic BPs at six months. Acute and long-term safety, with a focus on the renal artery and estimated glomerular filtration rate (eGFR), were assessed. Baseline office and ambulatory BPs were 182.4+/-18.4/100.2+/-14.0 mmHg and 153.0+/-15.1/87.5+/-13.2 mmHg, respectively. No acute renal artery injury requiring intervention or serious periprocedural cardiovascular events occurred. At six months, office BP was reduced by 24.7+/-22.1/10.3+/-12.7 mmHg (p<0.0001) and ambulatory BP was reduced by 8.4+/-14.4/5.9+/-9.1 mmHg (N=69; p<0.0001). Twenty-six patients (18%) achieved an office systolic BP <140 mmHg. One patient had renal artery stenosis which required stenting. Mean eGFR remained stable. Conclusion(s): Renal artery denervation with the Vessix System reduced both office and ambulatory BP at six months in patients with resistant hypertension. Renal artery safety and renal function results are favourable.Copyright © Europa Digital & Publishing 2015. All rights reserved.