Objective: To determine the frequency of perioperative complications since the introduction of abciximab, we prospectively evaluated our experience in a consecutive series of patients undergoing carotid angioplasty and stent placement (CAS). CAS has been introduced recently for treatment of carotid artery stenosis. A major limitation to this modality is the risk of perioperative thromboembolic and ischemic events. To reduce the risk of ischemic complications, abciximab, a platelet glycoprotein IIb/IIIa receptor inhibitor, has been introduced as adjunctive treatment for high-risk patients.
Methods: Each patient was evaluated by a neurologist before, immediately after, and 24 hours after CAS for identification and classification of new neurological deficits. Bleeding events or other complications during hospitalization were recorded. Bleeding complications were classified as major (hemoglobin decrease,g5 g/dl), minor (hemoglobin decrease, 3-5 g/dl), or insignificant. Abciximab was administered intravenously as a single bolus (0.25 mg/kg) and then via infusion (10 microg/min) for 12 hours as an adjunct to CAS in patients considered to be at high risk for thromboembolic events owing to recent ischemic symptoms and/or complex lesion morphology.
Results: Intravenously administered abciximab was used in 37 patients (mean age, 70 yr; 21 patients were men) as an adjunct to high-risk CAS. Thirty-three other patients underwent CAS performed with standard intraprocedural heparinization (mean age, 69 yr; 17 patients were men). Minor ischemic strokes were observed in 1 of 37 abciximab-treated patients and in 4 of 33 heparin-treated patients. No major ischemic strokes were observed in either group. Transient neurological deficits were observed in nine patients in the abciximab-treated group and in one patient in the heparin-treated group. Transient neurological deficits in abciximab-treated patients were mainly related to hemodynamic factors (associated with balloon inflation in two patients and with hypotension in another two patients) or occurred after completion of infusion (in three patients). Minor bleeding complications were observed in three patients who received abciximab and in four patients who received standard heparinization. Major bleeding complications were observed in four patients from each group. Two patients who received abciximab developed intracerebral hemorrhages; one hemorrhage was fatal.
Conclusion: The frequency of ischemic stroke in high-risk patients (3%) with the use of intravenously administered abciximab was lower, but not significantly so, than rates observed in lower-risk patients (12%), although the benefit was lost because of the high rate of intracranial hemorrhages (5%). Further efforts are required to determine appropriate selection criteria for use of intravenously administered abciximab and the effect of other strategies that involve distal protection devices.