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Circulation, Vol 83, 448-459, Copyright © 1991 by American Heart Association
JM Gore, M Sloan, TR Price, AM Randall, E Bovill, D Collen, S Forman, GL Knatterud, G Sopko and ML Terrin
In the Thrombolysis in Myocardial Infarction, Phase II pilot and clinical
trial, 908 patients [326 (35.9%) in the pilot study and 582 (64.0%) in the
randomized study] were treated with 150 mg recombinant tissue-type
plasminogen (rt-PA) activator in combination with heparin and aspirin, and
3,016 patients [64 (2.1%) in the pilot study and 2,952 (97.9%) in the
randomized study] were treated with 100 mg rt-PA in combination with
heparin and aspirin. Adverse neurological events occurred in 23 patients
treated with 150 mg rt-PA (2.5%) [nine cerebral infarctions (1.0%), 12
intracerebral hemorrhages (1.3%), and two subdural hematomas (0.2%)] and in
33 patients treated with 100 mg rt-PA (1.1%) [20 cerebral infarctions
(0.7%), 11 intracerebral hemorrhages (0.4%), and two subdural hematomas
(0.1%)]. The difference in adverse neurological events observed comparing
the two rt-PA regimens was primarily due to a higher frequency of
intracerebral bleeding among patients treated with 150 mg rt-PA (1.3%
versus 0.4%, p less than 0.01). Patients with recent (within 6 months)
histories of stroke were not eligible for the study, and patients with any
history of cerebrovascular disease were declared ineligible early in the
study. The small number of patients (89, or 2.3%) with any history of
neurological disease, intermittent cerebral ischemic attacks, or stroke who
were enrolled before the stricter eligibility criteria were imposed or on
the basis of incomplete baseline information experienced an increased
frequency of intracerebral hemorrhage compared with patients without such
histories (3.4% versus 0.5%). Mortality at 6 weeks after presentation among
23 patients who had intracerebral hemorrhage was 47.8%. Intracerebral
hemorrhage is a severe but infrequent complication of rt-PA therapy for
acute myocardial infarction. The combined frequency of intracerebral
hemorrhage, subdural hematoma, and cerebral infarction after treatment with
100 mg rt-PA is comparable to that observed in other trials with
thrombolytic agents in acute myocardial infarction.
ARTICLES
Intracerebral hemorrhage, cerebral infarction, and subdural hematoma after acute myocardial infarction and thrombolytic therapy in the Thrombolysis in Myocardial Infarction Study. Thrombolysis in Myocardial Infarction, Phase II, pilot and clinical trial
University of Massachusetts Medical School Worcester.
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