HVAD: The ENDURANCE Supplemental Trial
HVAD: The ENDURANCE Supplemental Trial
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DOI：
10.1016/j.jchf.2018.05.012
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发表时间：
2018-09-01
影响因子：
13
通讯作者：
Pagani, Francis D.
中科院分区：
文献类型：
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作者：
Milano, Carmelo A.;Rogers, Joseph G.;Pagani, Francis D.
目的：本研究的目的是前瞻性地评估血压管理对接受HeartWare HVAD系统的患者卒中发生率的影响。背景耐力试验显示，在不符合心脏移植资格的晚期心力衰竭患者中，HeartWare HVAD系统与对照组(HeartMate II)相比具有非劣性。然而，中风在HVAD受试者中更常见。方法耐力补充试验是一项前瞻性的多中心评估，纳入了465名不符合移植条件的晚期心力衰竭患者，随机分为2：1组(n=308)和对照组(n 1/4157)。主要终点是短暂性脑缺血发作或卒中的12个月发生率，并在事件发生后24周有残余缺陷。次要终点包括免于死亡、致残性中风、需要设备更换或紧急移植，以及耐力补充和ENDURANCE的HVAD队列中卒中或短暂性脑缺血发作发生率的比较。结果增强血压方案显著降低平均动脉压。没有达到主要终点(HVAD组14.7%，对照组12.1%，非劣势[边际6%]p=0.14)。然而，次级复合终点显示出HVAD(76.1%)优于对照组(66.9%)(p=0.04)。耐力补充组与耐力组相比，卒中发生率降低了24.2%(p=0.10)，出血性脑血管意外减少了50.5%(p=0.02)。结论耐力补充试验未能证明在预先指定的主要终点方面，HVAD与对照组相比并不逊色。然而，这项试验证实，BP管理与HVAD受试者中风发生率的降低有关。与对照受试者相比，HVAD受试者更常达到复合终点(免于死亡、卒中致残、装置更换或紧急移植)。(C)2018年作者。由爱思唯尔公司代表美国心脏病学会基金会出版。
OBJECTIVES The aim of this study was to prospectively evaluate the impact of blood pressure management on stroke rates in patients receiving the HeartWare HVAD System.BACKGROUND The ENDURANCE trial demonstrated noninferiority of the HeartWare HVAD System versus control (HeartMate II) in patients with advanced heart failure ineligible for heart transplantation. However, stroke was more common in HVAD subjects. Post hoc analyses demonstrated increased mean arterial blood pressure as a significant independent risk factor for stroke.METHODS The ENDURANCE Supplemental Trial was a prospective, multicenter evaluation of 465 patients with advanced heart failure ineligible for transplantation, randomized 2: 1 to HVAD (n = 308) or control (n 1/4 157). The primary endpoint was the 12-month incidence of transient ischemic attack or stroke with residual deficit 24 weeks post-event. Secondary endpoints included the composite of freedom from death, disabling stroke, and need for device replacement or urgent transplantation, as well as comparisons of stroke or transient ischemic attack rates in HVAD cohorts in ENDURANCE Supplemental and ENDURANCE.RESULTS The enhanced blood pressure protocol significantly reduced mean arterial blood pressure. The primary endpoint was not achieved (14.7% with HVAD vs. 12.1% with control, noninferiority [margin 6%] p = 0.14). However, the secondary composite endpoint demonstrated superiority of HVAD (76.1%) versus control (66.9%) (p = 0.04). The incidence of stroke in HVAD subjects was reduced 24.2% in ENDURANCE Supplemental compared with ENDURANCE (p = 0.10), and hemorrhagic cerebrovascular accident was reduced by 50.5% (p = 0.02).CONCLUSIONS The ENDURANCE Supplemental Trial failed to demonstrate noninferiority of HVAD versus control regarding the pre-specified primary endpoint. However, the trial confirmed that BP management is associated with reduced stroke rates in HVAD subjects. HVAD subjects, relative to control subjects, more commonly achieved the composite endpoint (freedom from death, disabling stroke, and device replacement or urgent transplantation). (C) 2018 The Authors. Published by Elsevier on behalf of the American College of Cardiology Foundation.