Baroreflex activation therapy met sustained efficacy and device safety endpoints but missed acute SBP response and procedural safety, with 42% vs 24% achieving SBP response in an ancillary analysis.
RCT (n=265)
Double-blind
2:1
Yes
Does baroreflex activation therapy lower systolic blood pressure in patients with resistant hypertension?
In patients with resistant hypertension, baroreflex activation therapy demonstrated sustained efficacy and device safety at 12 months, although it failed to meet acute responder and procedural safety endpoints at 6 months.
Objectives We sought to determine the effect of baroreflex activation therapy (BAT) on systolic blood pressure (SBP) in patients with resistant hypertension. Background The Rheos Pivotal Trial evaluated BAT for resistant hypertension in a double-blind, randomized, prospective, multicenter, placebo-controlled Phase III clinical trial. Methods This was a double-blind randomized trial of 265 subjects with resistant hypertension implanted and subsequently randomized (2: 1) 1 month after implantation. Subjects received either BAT (Group A) for the first 6 months or delayed BAT initiation following the 6-month visit (Group B). The 5 coprimary endpoints were: 1) acute SBP responder rate at 6 months; 2) sustained responder rate at 12 months; 3) procedure safety; 4) BAT safety; and 5) device safety. Results The trial showed significant benefit for the endpoints of sustained efficacy, BAT safety, and device safety. However, it did not meet the endpoints for acute responders or procedural safety. A protocol-specified ancillary analysis showed 42% (Group A) versus 24% (Group B) achieving SBP Original language English Pages (from-to) 765-773 Number of pages 9 Journal Journal of the American College of Cardiology Volume 58 Issue number 7 DOIs https://doi.org/10.1016/j.jacc.2011.06.008 Publication status Published - 9 Aug 2011 Keywords baroreflex medical device resistant hypertension
“This treatment is coming. The data were very encouraging. This is a modality that will work. I anticipate further studies to better define which patients get the greatest benefit.”
Bisognano et al. (Mon,) conducted a rct in Resistant hypertension (n=265). Baroreflex activation therapy (BAT) vs. Delayed BAT initiation was evaluated on 5 coprimary endpoints: acute SBP responder rate at 6 months, sustained responder rate at 12 months, procedure safety, BAT safety, and device safety. Baroreflex activation therapy met sustained efficacy and device safety endpoints but missed acute SBP response and procedural safety, with 42% vs 24% achieving SBP response in an ancillary analysis.