A randomized double-blind trial of intravenous trimetazidine as adjunctivetherapy to primary angioplasty for acute myocardial infarction

Background: Despite high patency rates, primary angioplasty for myocardial infarction does not necessarily result in optimal myocardial reperfusion an d limitation of infarct size. Experimentally, trimetazidine limits infarct size, decreases platelet aggregation, and reduces leukocyte influx into the infarct zone. To assess trimetazidine as adjunctive therapy to primary ang ioplasty for acute myocardial infarction a prospective, double-blind, place bo-controlled pilot trial was performed, Methods: 94 patients with acute my ocardial infarction were randomized to receive trimetazidine (40 mg bolus f ollowed by 60 mg/day intravenously for 48 h) (n = 44) or placebo (n = 50), starting before recanalization of the infarct vessel by primary angioplasty . Patients underwent continuous ST-segment monitoring to assess return of S T-segment deviation to baseline and presence of ST-segment exacerbation at the time of vessel recanalization. Infarct size was measured enzymatically from serial myoglobin measurements. Left ventricular angiography was perfor med before treatment and repeated at day 14. Results: Blinded ST segment an alysis showed that despite higher initial ST deviation from baseline in the trimetazidine group (355 (32) vs. 278 (29) muV, P = 0.07), there was an ea rlier and more marked return towards baseline within the first 6 h than in the placebo group (P = 0.014) (change: 245 (30) vs. 156 (31) muV respective ly, P = 0.044). There was a trend towards less frequent exacerbation of ST deviation at the time of recanalization in the trimetazidine group (23.3 vs . 42.2%, P = 0.11). There was no difference in left ventricular wall motion at day 14, or in enzymatic infarct size. There was mo side effect from tre atment. Clinical outcomes: were similar between groups. Conclusion: Trimeta zidine was safe and led to earlier resolution of ST-segment elevation in pa tients treated by primary angioplasty for acute myocardial infarction. (C) 2001 Elsevier Science Ireland Ltd. All rights reserved.