The European Cooperative Study Group trial of intravenous recombinant tissue-type plasminogen activator (rt-PA) and conservative therapy versus rt-PA and immediate coronary angioplasty

Abstract

This report describes the organization and results of the European Cooperative Study Group trial of intravenous recombinant tissue-type plasminogen activator (rt-PA) plus conservative therapy versus intravenous rt-PA plus immediate intervention (coronary angiography with a view to angioplasty) in patients with acute myocardial infarction. One hundred eighty-four patients were allocated to noninvasive treatment and 183 to an invasive/intervention policy. Immediate angioplasty was attempted in 168 patients (92%) of the latter group. The trial was terminated after a data review by the ethical monitoring committee showed no benefit in the "invasive" group in terms of enzymatic infarct size or left ventricular function, and a trend (although not statistically significant) toward increased mortality in the intervention group. Analysis of coronary patency and residual stenosis at the time of discharge showed no difference in patency rate, but less residual stenosis in the intervention group. The study differed from the Thrombolysis and Angioplasty in Myocardial Infarction (TAMI) and the Thrombolysis in Myocardial Infarction Phase-IIB (TIMI-IIB) trials in that the philosophy of intervention to produce the earliest and most complete reperfusion resulted in a high incidence of angioplasty procedures in vessels not yet reperfused. The reasons for the failure of this philosophy to show benefit are uncertain, but may include an increased risk of reocclusion after angioplasty or reperfusion damage, or both.