Baroreflex Activation Therapy Lowers Blood Pressure in Patients With Resistant Hypertension Results From the Double-Blind, Randomized, Placebo-Controlled Rheos Pivotal Trial
Baroreflex Activation Therapy Lowers Blood Pressure in Patients With Resistant Hypertension Results From the Double-Blind, Randomized, Placebo-Controlled Rheos Pivotal Trial
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DOI：
10.1016/j.jacc.2011.06.008
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发表时间：
2011-08-09
影响因子：
24
通讯作者：
Sica, Domenic A.
中科院分区：
文献类型：
--
作者：
Bisognano, John D.;Bakris, George;Sica, Domenic A.
目的：我们试图确定压力反射激活疗法（BAT）对顽固性高血压患者收缩压（SBP）的影响。安慰剂对照的III期临床试验。方法这是一个双-对265名植入了抗高血压药物并在植入后1个月随机分配（2：1）的受试者进行的盲态随机试验。受试者在前6个月接受BAT（A组）或在6个月访视后延迟BAT启动（B组）。5个共同主要终点为：1）6个月时的急性SBP应答率; 2）12个月时的持续应答率; 3）手术安全性; 4）BAT安全性; 5）器械安全性。然而，它不符合急性反应者或手术安全性的终点。方案规定的辅助分析显示42%（A组）与24%（B组）达到SBP
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