title: 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.
abstract: 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)
authors.affiliation: Department of Cardiology, Cleveland Clinic Foundation, Ohio 44195.
authors.forename: M M
authors.initials: MM
authors.lastname: Bernardi
authors.forename: R M
authors.initials: RM
authors.lastname: Califf
authors.forename: N
authors.initials: N
authors.lastname: Kleiman
authors.forename: S G
authors.initials: SG
authors.lastname: Ellis
authors.forename: E J
authors.initials: EJ
authors.lastname: Topol
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000818:Animals; D001760:Bleeding Time; D005260:Female; D006470:Hemorrhage / Q000097:blood / Q000209:etiology / Q000517:prevention & control*; D006801:Humans; D016014:Linear Models; D008297:Male; D051379:Mice; D008875:Middle Aged; D010865:Pilot Projects; D010980:Platelet Membrane Glycoproteins / Q000187:drug effects / Q000276:immunology* / Q000627:therapeutic use; D011237:Predictive Value of Tests
chemical_list: D010980:Platelet Membrane Glycoproteins