Incidence of intracranial hemorrhage complicating treatment with glycoprotein IIb/IIIa receptor inhibitors: A pooled analysis of major clinical trials

PURPOSE: The major risk of therapy with platelet glycoprotein IIb/IIIa rece ptor inhibitors is bleeding. We reviewed trials using these agents to deter mine if bleeding risks include an increased incidence of intracranial hemor rhage. METHODS: A Medline search identified 14 randomized trials of intravenous pl atelet glycoprotein IIb/IIIa receptor inhibitors for patients undergoing pe rcutaneous coronary intervention or who had an acute coronary syndrome. We compared the incidence of intracranial hemorrhage among 15,850 patients tre ated with glycoprotein IIb/IIIa inhibitors with that among 12,039 patients treated with placebo. RESULTS: The incidence of intracranial hemorrhage with heparin plus any IIb /IIIa inhibitor was similar to placebo with heparin (0.12% vs 0.09%, odds r atio = 1.3, 95% confidence interval: 0.6 to 3.1, P = 0.59). The incidence o f intracranial hemorrhage with glycoprotein IIb/IIIa drugs alone was simila r to that with heparin alone (0.07% vs 0.06%), albeit with a wide confidenc e interval (odds ratio = 1.2, 95% confidence interval: 0.1 to 16, P = 1.0). CONCLUSIONS: Intravenous glycoprotein IIb/IIIa receptor inhibitors alone or in combination with heparin do not cause a statistically significant exces s of intracranial hemorrhage as compared with heparin alone. Because of sma ll numbers, the data do not exclude the possibility of an excess of intracr anial hemorrhage in some groups of patients treated with glycoprotein IIb/I IIa receptor inhibitors. (C) 2000 by Excerpta Medics, Inc.