Safety of high-dose intravenous eptifibatide as an adjunct to internal carotid artery angioplasty and stent placement: a prospective registry.

Abstract

Eptifibatide, a competitive platelet glycoprotein IIb-IIIa receptor inhibitor with high selectivity for platelet glycoprotein IIb-IIIa receptors and a short half-life, has been shown to reduce the risk of ischemic events associated with coronary interventions, particularly when used in high doses. However, its role in conjunction with neurointerventional procedures needs to be determined. We report the results of an open-label prospective registry to evaluate the safety (in terms of avoiding hemorrhagic complications) and effectiveness (in terms of preventing ischemic complications such as stroke) of administering high-dose eptifibatide during internal carotid artery angioplasty and stent placement (CAS) for extracranial carotid artery stenosis. After femoral artery access was established and intravenous heparin (30 U/kg bolus) was administered, each patient was administered intravenous eptifibatide (two 180-microg/kg single-dose boluses before CAS, then a 2.0-microg/kg/min infusion for 20-24 hours thereafter). The primary end point was the 30-day composite occurrence of death, cerebral infarction, and unplanned or urgent endovascular or surgical intervention. The primary safety end point was bleeding, for which complications were classified according to the Thrombolysis in Myocardial Infarction scheme as major (hemoglobin decrease of more than 5 g/dl), minor (hemoglobin decrease of 3-5 g/dl), or insignificant. Platelet aggregation was measured in 13 consecutive patients with a rapid platelet-function analyzer. Twenty-six patients (mean age, 68.1 +/- 9.4 yr; 16 men) underwent treatment. The infusion and the CAS procedure were discontinued in one patient who developed angioneurotic edema after being administered intravenous heparin and the first bolus dose of eptifibatide. Among the 25 patients who underwent the procedure, no intracerebral hemorrhages and one minor ischemic stroke occurred during the 1-month follow-up period. The minor stroke was observed on postprocedure Day 7 in a patient for whom antiplatelet therapy was discontinued before a coronary artery bypass graft operation was performed. Another patient was discharged after an uncomplicated hospitalization but died as a result of urinary sepsis 12 days after CAS. One episode of major bleeding from the femoral insertion site required surgical repair and blood transfusions. Minor bleeding occurred in one patient. Platelet aggregation measurements obtained in 13 patients revealed a high degree (mean, 96%; range, 86-100%) of platelet inhibition after the administration of the second bolus dose of intravenous eptifibatide. High-dose eptifibatide administered as an adjunct to CAS seems to be safe. Further studies are required to analyze its effectiveness and role in neurointerventional procedures.