Lack of usefulness of prolonged bleeding times in predicting hemorrhagic events in patients receiving the 7E3 glycoprotein IIb/IIIa platelet antibody. The TAMI Study Group.

Journal Article (Clinical Trial;Journal Article;Multicenter Study)

Hemorrhagic events remain the most worrisome complication in patients receiving drugs that alter hemostasis for treatment of acute coronary syndromes. The 7E3 Fab monoclonal antibody provides a dose-dependent inhibition of platelet aggregation via the glycoprotein IIb/IIIa receptor. This study examines the correlation of hemostatic parameters with bleeding events in patients receiving intravenous 7E3 while enrolled in acute myocardial infarction and high-risk percutaneous transluminal coronary angioplasty pilot studies. Patients with acute myocardial infarction received 100 mg of tissue-type plasminogen activator over 3 hours followed by an escalating intravenous bolus dose of murine 7E3 (0.1 mg/kg [n = 5], 0.2 mg/kg [n = 22], 0.15 mg/kg [n = 13], 0.25 mg/kg [n = 20]). Patients in the high-risk angioplasty trial received a chimeric 7E3 bolus (up to 0.25 mg/kg) with (n = 32) or without (n = 15) intravenous continuous infusion of 7E3 (10 micrograms/min for 6 to 24 hours) after elective angioplasty. Patients in both studies received aspirin therapy (325 mg/day) and partial thromboplastin time-guided (1.5 to 2 times normal) heparin infusion. Bleeding events occurred in 34 of 124 patients (27%). The median template bleeding times (minutes) for patients in the groups with bleeding versus no bleeding events in the trials was 13.5 versus 14 and 30 versus 30, respectively (p = NS). In patients with myocardial infarction, a substantial decline in platelet count at 24 hours was associated with bleeding (p = 0.02).(ABSTRACT TRUNCATED AT 250 WORDS)

Full Text

Duke Authors

Cited Authors

  • Bernardi, MM; Califf, RM; Kleiman, N; Ellis, SG; Topol, EJ

Published Date

  • November 15, 1993

Published In

Volume / Issue

  • 72 / 15

Start / End Page

  • 1121 - 1125

PubMed ID

  • 8237799

Pubmed Central ID

  • 8237799

International Standard Serial Number (ISSN)

  • 0002-9149

Digital Object Identifier (DOI)

  • 10.1016/0002-9149(93)90979-m

Language

  • eng

Conference Location

  • United States