Thirty-eight coronary care units (CCUs) in France participated in this double-blind, placebo-controlled, multicentre study to assess the efficacy of flurbiprofen, a non-steroidal anti-inflammatory agent (NSAID) with potent anti-platelet activity (PAA), in the prevention and recurrence of myocardial infarction (MI) and reocclusion of the infarct-related artery (IRA) in patients successfully treated for acute MI by thrombolysis and/or coronary angioplasty within 6 h of onset of symptoms. A coronary angiogram was performed within the first 24 h to confirm successful reperfusion. Two hundred and thirty-three patients (group 1) were randomly allocated to flurbiprofen 50 mg twice daily and 228 patients (group 2) to placebo. All patients complied with the entry criteria, and drug treatment was commenced within 48 h of MI. Patients were assessed at 3 weeks, 3 months and 6 months, data being recorded on major clinical events and survival status. Overall mortality was low (1.1%) and similar for both groups, confirming the benefit of early reperfusion therapy. The reinfarction rate documented during the 6-month follow-up was 3% (7/233) in group 1 and 10.5% (24/228) in group 2 (P < 0.001). The need for coronary angioplasty and/or coronary bypass graft was decreased by 51% (group 1: 39/233 = 17%; group 2: 75/228 = 33%) (P < 0.001). Coronary angiogram at 6 months showed a similar reocclusion rate between treatments. Flurbiprofen appears to be an effective drug for the prevention of reinfarction after coronary reperfusion and in reducing the need for secondary revascularization procedures. It may offer advantages over aspirin, but comparable efficacy remains to be established.
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