2- AND 3-YEAR RESULTS OF THE THROMBOLYSIS IN MYOCARDIAL-INFARCTION (TIMI) PHASE-II CLINICAL-TRIAL

Objectives. This report describes the survival and reinfarction rates for 2- and 3-year follow up in the Thrombolysis in Myocardial Infarcti on (TIMI) Phase II clinical trial. Background. Patients enrolled in TI MI II were randomly assigned to an invasive (1,681 patients) or a cons ervative (1,658 patients) management strategy to follow receipt of int ravenous recombinant tissue-type plasminogen activator for acute myoca rdial infarction. Methods. Eligibility required presentation within 4 h of onset of symptoms and at least 1-mV ST segment elevation in two c ontiguous electrocardiographic leads. The invasive strategy group unde rwent cardiac catheterization 18 to 48 h after study entry and, when a ppropriate, percutaneous transluminal coronary angioplasty or coronary artery bypass grafting. In the conservative strategy group these diag nostic and revascularization procedures were reserved for recurrent sp ontaneous ischemia or ischemia on low level exercise at the time of ho spital discharge. Results. Complete 2-year follow-up data are availabl e for 3,187 patients (95.4%). Cumulative life-table rates of death or reinfarction were 17.6% for the invasive strategy group and 17.9% for the conservative strategy group (p=NS) and mortality was 8.9% and 8.7% (p=NS), respectively. Complete data are available for 1,959 (90.1%) o f the 2,174 patients enrolled for 3 years, Rates of death or reinfarct ion were 21.0% for the invasive strategy group and 20.0% for the conse rvative strategy group (p=NS), with mortality of 11.5% and 11.0% (p=NS ), respectively. In this cohort, the mortality was 1.3% in the 2nd yea r and 1.7% in the 3rd year from study entry. Conclusions. TIMI II inva sive and conservative strategies resulted is similar favorable outcome s after 2 and 3 years. Mortality and reinfarction rates in the two str ategies were com parable. Deaths were infrequent in the 2nd and 3rd ye ars from study entry.