Copyright © 2000 by the European Society of Cardiology.
Effect of 48-h intravenous trimetazidine on short- and long-term outcomes of patients with acute myocardial infarction, with and without thrombolytic therapy. A double-blind, placebo-controlled, randomized trial
revised December 21, 1999; accepted December 22, 1999Abstract
Aims To compare the effect of trimetazidine (TMZ) versus placebo administered during the acute phase of myocardial infarction on long- and short-term mortality.
Methods and Results EMIP–FR (European Myocardial Infarction Project–Free Radicals) was a prospective, double-blind, European multicentre trial in which 19725 patients, presenting symptoms of acute myocardial infarction within the previous 24h were randomized. Stratification was according to thrombolytic therapy (56%) or not (44%). An intravenous bolus injection of trimetazidine (40mg) was given just before or simultaneously with thrombolysis, followed by continuous infusion (60mg.24h–1) for 48h. Overall, no difference was found between trimetazidine and placebo for the main end-point, short-term (35-day) mortality, (P=0·98) in an intention-to-treat analysis. This was the result of opposing trends in the two strata. Thrombolysed patients showed a tendency towards more short-term deaths with trimetazidine, compared to placebo (trimetazidine: 11·3%, placebo: 10·5%, P=0·15) and non-thrombolysed patients the converse (trimetazidine: 14·0%, placebo: 15·1%, P=0·14). In a per-protocol analysis the beneficial effect of trimetazidine for non-thrombolysed patients became statistically significant (trimetazidine: 13·3%, placebo: 15·1%,P =0·027).
Conclusion Trimetazidine does not reduce mortality in patients undergoing thrombolytic therapy; however, it might have some beneficial effect for non-thrombolysed patients.
Key Words: Trimetazidine, myocardial infarction, thrombolysis, randomized controlled trial, free radicals
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