Open-label phase I clinical study to assess the safety of intravenous eptifibatide in patients undergoing internal carotid artery angioplasty and stent placement.

Abstract

Eptifibatide, a competitive platelet glycoprotein IIb-IIIa receptor inhibitor with high selectivity and a short half-life, has been demonstrated to reduce the risk of ischemic events associated with coronary interventions. However, its role in neurointerventional procedures needs to be analyzed. We report the results of an open-label Phase I study to evaluate the safety of the use of eptifibatide during carotid angioplasty and stent placement. Each study patient received eptifibatide administered intravenously as a 135-microg/kg single-dose bolus, then a 0.5-microg/kg/min infusion for 20 to 24 hours during carotid angioplasty and stent placement. The primary efficacy end point was the 30-day composite occurrence of death, cerebral infarction, transient ischemic attack, and unplanned or urgent surgical intervention, thrombolysis, or subsequent percutaneous revascularization. The primary safety end point was bleeding. Bleeding complications were classified as major (hemoglobin decrease >5 g/dl), minor (hemoglobin decrease 3-5 g/dl), or insignificant. Ten patients (mean age, 73 yr; four men) were treated by use of the study protocol. One patient developed a minor stroke postprocedurally (National Institutes of Health Stroke Scale score of 21 at 24 h that improved to 1 at 7 d). Three patients underwent scheduled coronary artery bypass graft surgery 4 to 12 days after undergoing carotid angioplasty and stent placement. At 1-month follow-up, no new ischemic events were observed. Major or minor bleeding was not observed in any patient. Insignificant bleeding was observed in two patients. The use of eptifibatide as an adjunct to carotid angioplasty and stent placement seems to be safe. Further studies are required to analyze the effectiveness and role of eptifibatide in neurointerventional procedures.