Recombinant tissue-type plasminogen activator and immediate angioplasty in acute myocardial infarction. One-year follow-up. The European Cooperative Study Group.

Abstract

BACKGROUND The European Cooperative Study Group conducted two randomized trials in patients with suspected myocardial infarction to assess the effect of 100 mg single-chain recombinant tissue-type plasminogen activator (rt-PA, alteplase) on enzymatic infarct size, left ventricular function, morbidity and mortality relative to placebo (alteplase/placebo trial) and to assess the effect of immediate percutaneous transluminal coronary angioplasty (PTCA) in addition to alteplase (alteplase/PTCA trial). One-year follow-up results are reported. METHODS AND RESULTS In the alteplase/placebo trial, 721 patients with chest pain of less than 5 hours and extensive ST-segment elevation were allocated at random to 100 mg alteplase or placebo (double-blind) over 3 hours. In the alteplase/PTCA trial, 367 similar patients received alteplase and subsequently were allocated at random to immediate coronary angiography and angioplasty of the infarct-related vessel or control. All patients received aspirin and intravenous heparin. In the alteplase/placebo trial, mortality during the first year was reduced by 36% with alteplase (from 9.3% to 5.6%; difference, -3.7%; 95% confidence interval, -7.5% to 0.2%). Revascularization was performed more frequently after alteplase, and more patients in the alteplase group were in New York Heart Association functional class I or II. Reinfarction tended to occur more frequently after alteplase than after placebo. In the alteplase/PTCA trial, reinfarction was less common after immediate PTCA, and revascularization procedures were less frequent. However, this benefit was offset by a high rate of immediate reocclusion and early recurrent ischemia and by higher mortality at 1 year (9.3% versus 5.4%; difference, 3.9%; 95% confidence interval, -1.5% to 9.2%) in the invasive group. In a multivariate analysis of 1,043 hospital survivors, mortality after discharge was related to coronary anatomy, left ventricular function, age, and previous infarction but not to initial treatment allocation. Reinfarction after hospital discharge tended to be more common after alteplase and related to coronary anatomy. CONCLUSIONS Benefit from treatment with alteplase, heparin, and aspirin is not diminished at 1 year. Routine immediate PTCA does not confer additional benefit. Prognosis after hospital discharge mainly is determined by coronary anatomy and residual left ventricular function and is unrelated to initial treatment assignment.

A perspective on the development of coronary revascularization

“…Thus, the appellation, thrombolytic drugs, is appropriate. It was soon found that intravenous administration of a thrombolytic drug reduced early mortality in patients with STEMI [23][24][25][26][27][28]. Subsequently, numerous randomized patient assignment clinical trials (RCTs) confirmed that reperfusion induced with diverse thrombolytic drugs enhanced early survival (reviewed in [3,4]).…”

Facilitated Percutaneous Coronary Intervention

“…The ECSG study was terminated early due to lack of demonstrated benefit and a non-significant trend toward increased mortality in the immediate invasive group (32). A subgroup analysis of the ECSG study suggested that re-occlusion and re-infarction were responsible for the lack of benefit of the early invasive strategy after t-PA and that perhaps procedural improvements in PTCA would lead to a benefit of immediate PTCA after thrombolysis (33).…”

Pharmacoinvasive Therapy

“…21,74 -76 More than one decade ago, clinicians were discouraged from proceeding to PCI early after fibrinolysis because of lack of benefit of such a strategy and a trend toward worse outcomes in several trials. [77][78][79] Given the advances in PCI described above and …”