Thrombolysis or nothing for acute myocardial infarction? It's all the same!

Abstract

AIMS: To assess the reliability of equivalence trials we tested whether the no-thrombolysis approach was equivalent to thrombolysis with streptokinase (SK) in acute myocardial infarction. METHODS: We applied the hypothesis of an equivalence trial of a recombinant plasminogen activator and SK to the GISSI-1 control group. RESULTS: In at least one of three subsets randomly extracted from the GISSI database the equivalence criterion was satisfied, i.e. death rates in patients given SK or not were similar enough to consider the no-thrombolysis regimen equivalent to thrombolytic treatment. Two-thirds of 100 replications of the sampling gave this result. CONCLUSIONS: These findings suggest the unreliability of equivalence trials, which should neither be adopted by the scientific community nor accepted by the regulatory authorities. © 2008 The Authors.