The Clinical Trials of the European Cooperative Study for Recombinant Tissue-Type Plasminogen Activator (rt-PA)
In Table 1 a historical review of the European Cooperative Study Group for rt-PA (ECSG) is listed. The benefit of thrombolytic therapy is conferred by reopening of occluded coronary arteries, leading to limitation of infarct size, preservation of left ventricular function and mortality reduction. Parallel to this pathophysiologic mechanism, the following outcome parameters were considered in the trials of the European Cooperative Study Group: early coronary patency, enzymatic infarct size and left ventricular function. A mortality trial, requiring thousands of patients, was considered unethical without any proof of efficacy of rt-PA in terms of coronary patency and infarct size limitation. Similarly, a trial measuring enzymatic infarct size and left ventricular ejection fraction, requiring several hundreds of patients could not be performed without proof of efficacy of rt-PA in terms of coronary patency. Assessment of the coronary recanalization rate required pre-treatment angiography, which would delay treatment and was therefore rejected. Furthennore, sequential assessment of patency at various times in one patient was omitted to avoid the effect of repeated contrast injections on coronary recanalization.
KeywordsPlacebo Depression Ischemia Titration Aspirin
Unable to display preview. Download preview PDF.
- 5.Serruys PW, Arnold AER, Brower RW, et al for the European Cooperative Study Group for rt-PA. Effect of continued rt-PA administration on the residual stenosis after initial successful recanalization in acute myocardial infarction-a quantitative coronary angiography study of a randomized trial. Eur Heart Journal 1987;8:1172–1181.Google Scholar
- 9.Arnold AER, Serruys PW, Rutsch W, et al for the European Cooperative Study Group for rt-PA. Reasons for no additional benefit of angioplasty immediately after recombinant tissue plasminogen activator for acute myocardial infarction: a regional wall motion analysis. J Am Col Cardiol 1991;17:11–21.CrossRefGoogle Scholar
- 10.de Bono DP, Simoons ML, Tijssen JGP, et al. Effect of early intravenous heparin on coronary patency, infarct size and bleeding complications after alteplase thrombolysis: results of a randomised double blind European Cooperative Study Group trial. Br Heart J 1992;67:122–128.PubMedCrossRefGoogle Scholar
- 12.Rapold HJ, de Bono DP, Arnold AER et al for the European Cooperative Study Group. Plasma fibrinopeptide A levels in patients with acute myocardial infarction treated with alteplase: correlation with concomittant heparin, coronary artery patency, and recurrent ischemia. Circulation 1992;85:928–34.PubMedCrossRefGoogle Scholar
- 13.Arnold AER, Brower RW, Collen D, et al for the European Co-operative Study Group forrt-PA. Fibrin(ogen) degradation products by recombinant human tissue-type plasminogen activator for acute myocardial infarction are related to bleeding complications, but not to coronary patency. J Am Coll Cardiol 1989;14:581–8.PubMedCrossRefGoogle Scholar
- 14.Arnold AER, Simoons ML, Detry JMR, et al for the European Cooperative Study Group. Prediction of mortality after hospital discharge in patients treated with and without recombinant tissue plasminogen activator for myocardial infarction: is there a need for coronary angiography? European Heart Journal 1993;14:306–315.PubMedCrossRefGoogle Scholar
- 15.Willems JL, Willems RJ, Willems GM, Arnold AER, Van de Werf F and Verstraete M, for the European Cooperative Study Group for rt-PA. The significance of initial ST-segment elevation and depression for the management of thrombolytic therapy in acute myocardial infarction. Circulation 1990;82:1147–1158.PubMedCrossRefGoogle Scholar