Baroreflex Activation Therapy in Patients With Heart Failure With Reduced Ejection Fraction
Baroreflex Activation Therapy in Patients With Heart Failure With Reduced Ejection Fraction
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DOI：
10.1016/j.jacc.2020.05.015
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发表时间：
2020-07-07
影响因子：
24
通讯作者：
Abraham, William T.
中科院分区：
文献类型：
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作者：
Zile, Michael R.;Lindenfeld, Joann;Abraham, William T.
本研究证实了压力反射激活疗法（BAT）在射血分数降低的心力衰竭（HFrEF）患者中的安全性和有效性。（压力反射激活疗法治疗心力衰竭）试验是一项多中心、前瞻性、随机、对照试验;受试者按1：1人接受最佳可得技术加最佳医疗管理（BAT组）或单独进行最佳医疗管理方法使用以下入选标准从408名随机化的HFrEF患者创建四个患者群组：当前纽约心脏协会（NYHA）心功能III级或心功能II级（近期有NYHA心功能III级病史的患者）;射血分数= 4周;无心脏瓣膜置换治疗的I级适应症。有效性终点为6分钟走廊步行距离（6 MHW）、明尼苏达HF生活问卷生活质量（QOL）评分和N末端B型利钠肽前体（NT-proBNP）水平从基线至6个月的变化。安全性终点包括主要神经系统或心血管系统或手术相关不良事件发生率（MANCE）。结果：A、B和C组的结果、时间轴和基本原理详见正文。队列D，代表反映美国食品药品监督管理局批准的使用说明书的预期使用人群（入组标准+NT-proBNP
BACKGROUND This study demonstrated the safety and effectiveness of baroreflex activation therapy (BAT) in patients with heart failure with reduced ejection fraction (HFrEF).OBJECTIVES 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).METHODS 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 = 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 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