TY - JOUR
T1 - The rematch trial
T2 - Rationale, design, and end points
AU - Rose, Eric A.
AU - Moskowitz, Alan J.
AU - Packer, Milton
AU - Sollano, Josephine A.
AU - Williams, Deborah L.
AU - Tierney, Anita R.
AU - Heitjan, Daniel F.
AU - Meier, Paul
AU - Ascheim, Deborah Davis
AU - Levitan, Ronald G.
AU - Weinberg, Alan D.
AU - Stevenson, Lynne Warner
AU - Shapiro, Peter A.
AU - Lazar, Ronald M.
AU - Watson, John T.
AU - Goldstein, Daniel J.
AU - Gelijns, Annetine C.
PY - 1999/3
Y1 - 1999/3
N2 - 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.
AB - 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.
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U2 - 10.1016/S0003-4975(99)00042-9
DO - 10.1016/S0003-4975(99)00042-9
M3 - Article
C2 - 10215217
AN - SCOPUS:0032909782
SN - 0003-4975
VL - 67
SP - 723
EP - 730
JO - Annals of Thoracic Surgery
JF - Annals of Thoracic Surgery
IS - 3
ER -