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June 1, 2005

Reviparin in Acute Myocardial Infarction

Author Affiliations

Letters Section Editor: Robert M. Golub, MD, Senior Editor.

JAMA. 2005;293(21):2595-2596. doi:10.1001/jama.293.21.2595-a

To the Editor: The Clinical Trial of Reviparin and Metabolic Modulation in Acute Myocardial Infarction Treatment Evaluation (CREATE)1 concludes that, in patients with acute ST-elevation myocardial infarction (STEMI), reviparin reduces overall mortality and reinfarction at 7 days (P = .005) and 30 days (P = .001). This is a megatrial involving 15 570 patients designed to detect a 15% relative risk (RR) reduction on the composite outcome at 7 days with a power of 93%. Although this conclusion is correct based on the applied analysis, it is important to examine the magnitude of the composite mortality reduction. The CREATE trial is similar to the Facile Interpretation of Statistical Hypotheses (FISH) trial postulated by Diamond and Kaul.2 The CREATE trial shows an absolute reduction in the first coprimary composite outcome at 7 days of 1.4%. Using a Bayesian approach with a noninformative prior (prior log odds ratio [OR] distribution with mean, 0 and SD, 10), as the CREATE trial was the first and only trial of this treatment that had been conducted, the posterior probability for more than 15% benefit is only 41%, whereas it is 95% for a threshold of benefit of 6%.

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