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Editor's Note
June 30, 2021

ISAR-REACT 5 Revisited Through the Lens of a Postrandomization Subgroup

Author Affiliations
  • 1Center for Interventional Vascular Therapy, Division of Cardiology, Columbia University Irving Medical Center/NewYork-Presbyterian Hospital and the Cardiovascular Research Foundation, New York, New York
  • 2Associate Editor, JAMA Cardiology
JAMA Cardiol. 2021;6(10):1129. doi:10.1001/jamacardio.2021.2238

Within trials comparing pharmacologic strategies for patients with acute coronary syndromes (ACS), it has become the norm to analyze and publish a subgroup analysis of the primary treatment assignment among patients who go on to undergo percutaneous coronary intervention (PCI) in the trial. Although informative in the sense that an analysis of the PCI subgroup addresses the treatment effect among patients undergoing a very different treatment strategy compared with medical therapy or surgical revascularization, the fact that this subgroup by definition is created and occurs after randomization renders treatment comparisons more challenging to interpret. The methodological issues inherent to postrandomization subgroup analyses in the ACS space have been explored in the literature1 and, at the very least, suggest that one ought to be circumspect in the interpretation of these analyses.

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