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June 1, 2005

Reviparin in Acute Myocardial Infarction—Reply

Author Affiliations

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

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

In Reply: Dr Buccelletti makes some incorrect assertions that result in a misleading interpretation. It is inappropriate to use a prior distribution that assumes no expectation of benefit (which is the assumption of a noninformative prior). No investigator initiates a trial without prior expectations, and in this case, we expected reviparin to be beneficial based on a meta-analysis of previous trials of low-molecular-weight heparin vs placebo, albeit on a moderate number of patients, which indicated a reduction in myocardial reinfarction (OR, 0.54; 95% CI, 0.33-0.91) and a nonsignificant reduction in deaths (OR, 0.91; 95% CI, 0.59-1.39).1 If we use a prior distribution of benefit in the moderate range (10%, 15%, or 20% RR reduction), the mid-point of the posterior estimate after CREATE is 13.7%, 14.1%, and 14.5%, respectively. In this case, both the frequentist and Bayesian approaches provide similar estimates of the benefits of reviparin. Comparison of the relative effect on reductions in mortality or myocardial reinfarction with the relative effects on bleeding is misleading, as the event rates of the former are approximately 15 times higher than that of the latter. The absolute benefits (18 fewer primary outcomes per 1000 patients treated) of reviparin vastly outweigh the risks (1 more life-threatening bleed per 1000 patients treated).

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