Therapy Immediate Angioplasty Yields No Additional Benefit in Acute MI ... . . . over conventional thrombolytic therapy with plasminogen activator

The European Cooperative Study Group for Recombinant Tissue-Type Plasminogen Activator performed a multlcentre randomlsed trral designed to assess the efficacy and tolerability of a strategy combining thrombolysIs with plasminogen activator, heparrn and aspirin plus Immediate percutaneous translumlnal coronary angloplasty (PTCA) against thrombolytic treatment alone. 367 patients with acute myocardial Infarction (MI) were allocated to either invasive (n = 183) or non-Invasive (n = 184) treatment Within 5 hours of symptom onset, all patients received IV plasminogen activator 100mg over 3 hours, IV aspirin 250mg and IV heparin 5000 IU, followed by continuous heparin infusion at 1000 IU/hour.

Following immediate angioplasty and angiography in 180 patients, 103 patients had < 50% stenosis in the affected vessel compared with 9 patients before treatment. The number of patients with occluded vessels also improved from 72 to 17 following invasive treatment. Corresponding improvements were evident in coronary perfusion. Transient and permanent reocclusion occurred in 22 and 12 patients, respectively. Clinically, there were episodes of recurrent ischaemia (17 vs 36, invasive vs non-invasive treatment), bleeding complications (41 vs 23%), hypotension (31 vs 9%) and ventricular fibrillation (11 vs 3%). Mortality following invasive vs non-invasive treatment was higher at both 14 days (7 vs 3%) and 3 months (8 vs 3%). Immediate angioplasty did not improve global left ventricular ejection fraction as visualised at late angiography, nor did it reduce the infarct size when compared with non-invasive treatment.

'Contrary to what was expected when the study was designed, thrombolytic therapy combined with Immediate PTCA did not appear to be superior to early non-invasive treatment with Intravenous rTPA [recombinant tissue plasminogen activator], heparin, and acetylsalicylic acid [aspirin] in acute myocardial infarction.' The data monitoring and ethical committees prematurely terminated this trial as a result of these findings. Simoons M L, Arnold AER. Betriu A. De Bono D P, Col J. et at. Lancet 1: 197·202,30 Jan 1988

0156-2703/88/0213-0007/0S01.00/0 © ADIS Press INPHARMA' 13 February 1988 7