Rose E A, Moskowitz A J, Packer M, Sollano J A, Williams D L, Tierney A R, Heitjan D F, Meier P, Ascheim D D, Levitan R G, Weinberg A D, Stevenson L W, Shapiro P A, Lazar R M, Watson J T, Goldstein D J, Gelijns A C
International Center for Health Outcomes and Innovation Research, Columbia University, New York, New York 10032, USA.
Ann Thorac Surg. 1999 Mar;67(3):723-30. doi: 10.1016/s0003-4975(99)00042-9.
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.
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).
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.
由于最近美国食品药品监督管理局已批准左心室辅助装置用于支持等待心脏移植的终末期心力衰竭患者的循环，这些装置越来越被视为生物心脏替代的潜在替代品。充血性心力衰竭机械辅助治疗随机评估（REMATCH）试验是一项由美国国立心肺血液研究所支持的多中心研究，旨在比较左心室辅助装置长期植入与最佳药物治疗对需要但不符合心脏移植条件的终末期心力衰竭患者的效果。
我们讨论了开展REMATCH试验的基本原理、设计该试验及其他随机外科试验的障碍、开展多中心试点研究的经验教训以及REMATCH研究设计的特点（目标、目标人群、治疗方法、终点、分析和试验组织）。
我们思考将从REMATCH试验中学到什么、对扩大左心室辅助装置使用的期望以及评估临床程序的未来方向。
