The rematch trial: Rationale, design, and end points

Eric A. Rose, Alan J. Moskowitz, Milton Packer, Josephine A. Sollano, Deborah L. Williams, Anita R. Tierney, Daniel F. Heitjan, Paul Meier, Deborah Davis Ascheim, Ronald G. Levitan, Alan D. Weinberg, Lynne Warner Stevenson, Peter A. Shapiro, Ronald M. Lazar, John T. Watson, Daniel J. Goldstein, Annetine C. Gelijns

Research output: Contribution to journalArticlepeer-review

303 Scopus citations

Abstract

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.

Original languageEnglish (US)
Pages (from-to)723-730
Number of pages8
JournalAnnals of Thoracic Surgery
Volume67
Issue number3
DOIs
StatePublished - Mar 1999

ASJC Scopus subject areas

  • Surgery
  • Pulmonary and Respiratory Medicine
  • Cardiology and Cardiovascular Medicine

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