Equipoise in the enhanced supression of the platelet IIb/IIIa receptor with integrilin trial (ESPRIT): a critical appraisal.
Enhanced Supression of the Platelet IIb/IIIa Receptor with Integrilin Trial (ESPRIT) was a multicenter randomized controlled clinical trial in which participants were randomized between eptifibatide and placebo. A "clinical hold" was initially placed on the trial by the US Food and Drug Administration (FDA), which was concerned about the placebo-only control arm. The hold was lifted after additional information concerning the use of platelet glycoprotein IIb/IIIa inhibitors in clinical practice, derived from a survey of interventional cardiologists, was provided. The trial's principal investigator and colleagues have described how these issues were resolved, and advance a claim of equipoise for the trial. In this critical appraisal we examine the information and arguments proffered in support of the trial design and conclude that they evidence a misunderstanding of equipoise. We believe that a placebo-only control arm was not justified by the information provided by the trialists.
Mann
Howard
H
Department of Radiology, University of Utah School of Medicine, Salt Lake City, Utah 84132, USA. howard.mann@hsc.utah.edu
London
Alex John
AJ
Mann
Jeffrey
J
D015906:Angioplasty, Balloon, Coronary; D001291:Attitude of Health Personnel; D026661:Clinical Trials Data Monitoring Committees / Q000941:ethics; D003365:Costs and Cost Analysis; D000077542:Eptifibatide; D032984:Ethics, Research; D006801:Humans; D015337:Multicenter Studies as Topic; D018579:Patient Selection; D010455:Peptides / Q000627:therapeutic use*; D010820:Physicians; D010919:Placebos; D010975:Platelet Aggregation Inhibitors / Q000627:therapeutic use*; D019039:Platelet Glycoprotein GPIIb-IIIa Complex / Q000037:antagonists & inhibitors*; D016032:Randomized Controlled Trials as Topic / Q000941:ethics*; D012107:Research Design; D012941:Social Responsibility; D015607:Stents; D014481:United States; D014486:United States Food and Drug Administration
D010455:Peptides; D010919:Placebos; D010975:Platelet Aggregation Inhibitors; D019039:Platelet Glycoprotein GPIIb-IIIa Complex; D000077542:Eptifibatide