Circulation, Vol 85, 533-542, Copyright © 1992 by American Heart Association
DO Williams, E Braunwald, G Knatterud, J Babb, J Bresnahan, MA Greenberg, A Raizner, A Wasserman, T Robertson and R Ross
BACKGROUND. The Thrombolysis in Myocardial Infarction (TIMI) Phase II Trial
randomized 3,339 patients to either an invasive (INV, n = 1,681) or a
conservative (CON, n = 1,658) strategy after intravenous recombinant
tissue-type plasminogen activator (rt-PA) for acute myocardial infarction.
METHODS AND RESULTS. The patients assigned to the INV strategy routinely
underwent cardiac catheterization, and when anatomically appropriate,
percutaneous transluminal coronary angioplasty (PTCA) or coronary artery
bypass grafting 18-48 hours after infarction. CON patients had these
procedures only in response to the occurrence of spontaneous or provoked
ischemia. One-year follow-up data are available in 3,316 patients (99.3%).
The primary trial end point, death and nonfatal reinfarction, occurred in
14.7% of INV patients and in 15.2% of CON patients (p = NS). When analyzed
individually, there was no difference (p = NS) in death (INV, 6.9%; CON,
7.4%) or recurrent infarction (INV, 9.4%; CON, 9.8%) between the two
groups. Anginal status at 1 year was also similar. Cardiac catheterization
and PTCA were performed more often in INV (98.0% and 61.2%, respectively)
compared with CON (45.2% and 20.5%, respectively) patients. At 1 year, the
cumulative number of patients who underwent coronary bypass surgery (INV,
17.5%; CON, 17.3%) was similar in the two groups. CONCLUSIONS. The INV and
CON strategies resulted in similar favorable outcomes at 1 year of
follow-up. In particular, the rates of mortality and reinfarction were not
different and were impressively low in both groups. One possible advantage
of the INV strategy was detected in subgroup analyses. In patients with a
history of myocardial infarction, the data are suggestive that 1-year
mortality was lower in INV patients (10.3%) than in CON patients (17.0%) (p
= 0.03).
ARTICLES
One-year results of the Thrombolysis in Myocardial Infarction investigation (TIMI) Phase II Trial
Department of Medicine, Rhode Island Hospital, Brown University, Providence.
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