The REMATCH trial: Rationale, design, and end points
The REMATCH trial: Rationale, design, and end points
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DOI：
10.1016/s0003-4975(99)00042-9
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发表时间：
1999-03-01
影响因子：
4.6
通讯作者：
Gelijns, AC
中科院分区：
文献类型：
--
作者：
Rose, EA;Moskowitz, AJ;Gelijns, AC
背景由于左心室辅助装置最近已被美国食品和药物管理局批准用于支持等待心脏移植的终末期心力衰竭患者的循环，因此这些装置越来越多地被认为是生物心脏置换术的潜在替代品。充血性心力衰竭机械辅助治疗的随机评价（REMATCH）试验是一项由国家心肺血液研究所支持的多中心研究，旨在比较需要但不符合接受心脏移植条件的终末期心力衰竭患者长期植入左心室辅助装置与最佳医疗管理。我们讨论了进行REMATCH的基本原理、设计本研究和其他随机手术试验的障碍、进行多中心初步研究的经验教训以及REMATCH研究设计的特点（目的、目标人群、治疗方法、终点、分析和试验组织）。我们考虑了从REMATCH中可以学到什么、对扩大左心室辅助装置使用的期望以及评估临床手术的未来方向。(Ann Thorac Surg 1999;67：723-30）（C）1999年，胸外科医师协会。
Background. Because left ventricular assist devices have recently been approved by the Food and Drug Administration to support the circulation of patients with end-stage heart failure awaiting cardiac transplantation, these devices are increasingly being considered as a potential alternative to biologic cardiac replacement. The Randomized Evaluation of Mechanical Assistance for the Treatment of Congestive Heart Failure (REMATCH) trial is a multicenter study supported by the National Heart, Lung, and Blood Institute to compare long-term implantation of left ventricular assist devices with optimal medical management for patients with end-stage heart failure who require, but do not qualify to receive cardiac transplantation.Methods. We discuss the rationale for conducting REMATCH, the obstacles to designing this and other randomized surgical trials, the lessons learned in conducting the multicenter pilot study, and the features of the REMATCH study design (objectives, target population, treatments, end points, analysis, and trial organization).Conclusions. We consider what will be learned from REMATCH, expectations for expanding the use of left ventricular assist devices, and future directions for assessing clinical procedures. (Ann Thorac Surg 1999;67:723-30) (C) 1999 by The Society of Thoracic Surgeons.