Prospective registry of carotid artery stenting in Japan--investigation on device and antiplatelet for carotid artery stenting.

Background: Carotid artery stenting (CAS) is minimally invasive but may cause perioperative cerebral infarction associated with distal embolization. We conducted a multicenter prospective observational study on the onset of vascular events after CAS to find out the efficacy and safety of CAS in Japan and to investigate the effects of antiplatelet drugs administered before and after CAS on efficacy and safety of CAS.
Methods: A total of 949 patients with cervical carotid artery stenosis were enrolled at 43 institutions in Japan; 934 who had undergone CAS with antiplatelet drugs and followed for 1 year were analyzed. Primary end point was the incidence of the first event of death, ischemic stroke, hemorrhagic stroke, transient ischemic attack, myocardial infarction, or serious hemorrhage within 1 year after enrollment. Comparison of the incidences of events according to antiplatelet drugs was also conducted.
Results: The primary end point was observed in 69 patients (7.4%) within 30 days of enrollment and in 40 patients (4.3%) between 31 days and 1 year after enrollment. The incidence of the first event for aspirin+cilostazol was significantly lower than that for aspirin+clopidogrel (P=.01), aspirin+clopidogrel+cilostazol (P=.01), and antiplatelet monotherapy (P<.01). Patient age (P=.01), presence of ischemic cerebrovascular disease (P=.02), presence of antidiabetic drugs (P<.01), femoral artery puncture (P=.02), guiding catheter used (P=.02), and Angioguard XP used (P=.01) were also correlated with the primary end point.
Conclusion: Incidences of the primary end point within 30 days and 1 year of enrollment were comparable with previous reports, suggesting that CAS is a useful alternative for carotid endarterectomy in carotid stenosis patients with high risk for carotid endarterectomy. Further randomized controlled studies are needed to determine whether differences in mechanism of action of antiplatelet drugs might have contributed to the results of the present study.
(Copyright © 2014 National Stroke Association. Published by Elsevier Inc. All rights reserved.)