Primary Composite Outcome Corrected in a Trial of Transfusion Strategy
To the Editor We wish to report corrections to our study of a restrictive vs liberal blood transfusion strategy on major cardiovascular events among patients with acute myocardial infarction and anemia. During secondary analyses of the trial results related to heart failure, it became apparent that the original analysis of the primary composite outcome had mistakenly included heart failure events as a component of the primary outcome (although heart failure events were adjudicated, they were not part of the prespecified primary composite outcome, which included all-cause death, stroke, recurrent myocardial infarction, or emergency revascularization prompted by ischemia at 30 days). In addition, the date of consent withdrawal was recorded incorrectly for 4 patients (before 30 days rather than after 30 days). Thus, as specified in the protocol and statistical analysis plan, they should have been considered missing, but had been coded as “no event.”