Abstract
Dr Elliott Antman, of Harvard Medical School and Brigham and Women’s Hospital in Boston, Massachusetts, presented the results of the Thrombolysis in Myocardial Infarction (TIMI) 9B study at a Satellite Symposium sponsored by George Washington University immediately prior to the American Heart Association Meetings in Anaheim, California, in November 1995. The TIMI 9 trial was a randomized, double-blind study conducted in 150 clinical centers that was designed to compare the efficacy and safety of intravenous heparin versus the direct-acting thrombin inhibitor hirudin in patients with acute myocardial infarction (<12 hours from onset) treated with a thrombolytic agent (streptokinase or tissue-type plasminogen activator [TPA], at the discretion of the treating physician). The TIMI 9A study (n=757) was suspended in April 1994 because of excessive bleeding in both the heparin and hirudin groups. The TIMI 9B trial was restarted in May 1994 with lower doses of both heparin and hirudin; enrollment (n=3002) continued through August 1995. The primary end point of the study was the 30-day incidence of death, myocardial infarction, congestive heart failure, and shock. At 30 days, there was no significant difference in the primary end point between heparin (11.8%) and hirudin (12.8%) and no difference in the incidence of death and myocardial infarction (9.3% in the heparin group, 9.6% in the hirudin group). Similarly, there was no significant difference in major bleeding events (including intracranial hemorrhage) between treatment groups. The TIMI 9 Investigators concluded that hirudin was equally effective as but not superior to heparin with respect to either clinical outcome or bleeding risk in patients with acute myocardial infarction receiving thrombolytic therapy. Also at the George Washington University Satellite Symposium, Dr Eugene Braunwald, of Harvard Medical School and Brigham and Women’s Hospital in Boston, presented the results of the TIMI 10A phase I trial. TIMI 10A is an …
Published Version
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