Medical University of South Carolina, Charleston, South Carolina; Ralph H. Johnson Department of Veterans Affairs Medical Center, Charleston, South Carolina.
Vanderbilt Heart and Vascular Institute, Nashville, Tennessee.
J Am Coll Cardiol. 2020 Jul 7;76(1):1-13. doi: 10.1016/j.jacc.2020.05.015.
This study demonstrated the safety and effectiveness of baroreflex activation therapy (BAT) in patients with heart failure with reduced ejection fraction (HFrEF).
The BeAT-HF (Baroreflex Activation Therapy for Heart Failure) trial was a multicenter, prospective, randomized, controlled trial; subjects were randomized 1:1 to receive either BAT plus optimal medical management (BAT group) or optimal medical management alone (control group).
Four patient cohorts were created from 408 randomized patients with HFrEF using the following enrollment criteria: current New York Heart Association (NYHA) functional class III or functional class II (patients who had a recent history of NYHA functional class III); ejection fraction ≤35%; stable medical management for ≥4 weeks; and no Class I indication for cardiac resynchronization therapy. Effectiveness endpoints were the change from baseline to 6 months in 6-min hall walk distance (6MHW), Minnesota Living with HF Questionnaire quality-of-life (QOL) score, and N-terminal pro-B-type natriuretic peptide (NT-proBNP) levels. The safety endpoint included the major adverse neurological or cardiovascular system or procedure-related event rate (MANCE).
Results from, timeline and rationale for, cohorts A, B, and C are presented in detail in the text. Cohort D, which represented the intended use population that reflected the U.S. Food and Drug Administration-approved instructions for use (enrollment criteria plus NT-proBNP <1,600 pg/ml), consisted of 245 patients followed-up for 6 months (120 in the BAT group and 125 in the control group). BAT was safe and significantly improved QOL, 6MHW, and NT-proBNP. In the BAT group versus the control group, QOL score decreased (Δ = -14.1; 95% confidence interval [CI]: -19 to -9; p < 0.001), 6MHW distance increased (Δ = 60 m; 95% CI: 40 to 80 m; p < 0.001), NT-proBNP decreased (Δ = -25%; 95% CI: -38% to -9%; p = 0.004), and the MANCE free rate was 97% (95% CI: 93% to 100%; p < 0.001).
BAT was safe and significantly improved QOL, exercise capacity, and NT-proBNP. (Baroreflex Activation Therapy for Heart Failure [BeAT-HF]; NCT02627196).
本研究证明了心脏衰竭射血分数降低（HFrEF）患者的压力反射激活治疗（BAT）的安全性和有效性。
BeAT-HF（心脏压力反射激活治疗）试验是一项多中心、前瞻性、随机、对照试验；将 408 名 HFrEF 随机患者分为 1:1 组，分别接受 BAT 加最佳药物治疗（BAT 组）或单纯最佳药物治疗（对照组）。
使用以下纳入标准从 408 名随机 HFrEF 患者中创建了 4 个患者队列：当前纽约心脏协会（NYHA）功能 III 级或 II 级（近期 NYHA 功能 III 级病史的患者）；射血分数≤35%；稳定的药物治疗≥4 周；无心脏再同步治疗 I 类适应证。有效性终点是 6 个月时与基线相比 6 分钟步行距离（6MHW）、明尼苏达州心力衰竭生活质量（QOL）评分和 N 端脑利钠肽前体（NT-proBNP）水平的变化。安全性终点包括主要不良神经或心血管系统或与程序相关的事件发生率（MANCE）。
本文详细介绍了队列 A、B 和 C 的时间线和原理。队列 D 代表反映美国食品和药物管理局批准的使用说明（纳入标准加 NT-proBNP<1600pg/ml）的预期使用人群，包括 245 名接受 6 个月随访的患者（BAT 组 120 例，对照组 125 例）。BAT 是安全的，可显著改善生活质量、6MHW 和 NT-proBNP。与对照组相比，BAT 组的 QOL 评分下降（Δ=-14.1；95%置信区间[CI]：-19 至-9；p<0.001），6MHW 距离增加（Δ=60m；95%CI：40 至 80m；p<0.001），NT-proBNP 下降（Δ=-25%；95%CI：-38%至-9%；p=0.004），MANCE 无事件率为 97%（95%CI：93%至 100%；p<0.001）。
BAT 是安全的，可显著改善生活质量、运动能力和 NT-proBNP。（心脏压力反射激活治疗[BeAT-HF]；NCT02627196）。
