REDUCE-HTN PMS Interim Analysis Presented

October 10, 2013—The REDUCE-HTN postmarket study's interim analysis was presented by Dierk Scheinert, MD, at a late-breaking trial session during the VIVA 2013: Vascular Interventional Advances conference, being held October 8–11 in Las Vegas, Nevada.

The ongoing multicenter, single-arm REDUCE-HTN clinical study is designed to evaluate the safety and performance of the Vessix renal denervation system (Boston Scientific Corporation, Natick, MA) in the treatment of patients with medication-resistant hypertension.

The Vessix system consists of an over-the-wire, low-pressure (3 atm) balloon catheter with an array of bipolar radiofrequency electrodes mounted in an offset helical pattern on the exterior of the balloon. A custom radiofrequency generator controls temperature at 68° C, delivers radiofrequency energy to all electrodes simultaneously for 30 seconds, and confirms apposition via impedance.

Patients were required to have an office-based systolic blood pressure ≥ 160 mmHg despite compliance with a regimen of three or more antihypertensive medications at maximally tolerated doses. Among the 107 patients (59±11 years, 62% men, 28% diabetic) who have completed 6 months of follow-up, mean (± SD) baseline office blood pressure (OBP) was 184 ± 19/99 ± 15 mm Hg. At 6-months post-treatment, mean OBP was 158 ± 24/89 ± 16 mmHg, demonstrating a significant OBP reduction (P < .001) of -25 ± 22/-10 ± 13 mm Hg when compared with baseline.

Subgroup analyses showed significant OBP reductions for both men and women, for patients with diabetes, and for those age 65 or older. Five procedure-related serious adverse events were reported through 6 months of follow-up, with only one report of a device-related serious adverse event (stenosis).

Dr. Scheinert concluded that preliminary REDUCE-HTN results continue to indicate that the Vessix system is a safe and effective method of renal denervation for different subgroups of patients with resistant hypertension.