Nobuyuki Sakai1, Hiroshi Yamagami2, Yoshihiro Matsubara3, Masayuki Ezura4, Akio Hyodo5, Yuji Matsumaru6, Shigeru Miyachi7, Yasushi Okada8, Tomoaki Terada9, Hiroyoshi Yokoi10, Mitusugu Nakamura11, Yasushi Matsumoto12, Chiaki Sakai13. 1. Department of Neurosurgery and KCGH Comprehensive Stroke Center, Kobe City Medical Center General Hospital, Kobe. Electronic address: nbyksakai@gmail.com. 2. Department of Stroke and Cerebrovascular Diseases, National Cerebral and Cardiovascular Center, Suita. 3. Department of Statistical Analysis, Translational Research Informatics Center, Kobe. 4. Department of Neurosurgery, Sendai Medical Center, Sendai. 5. Department of Neurosurgery, Dokkyo Medical University Koshigaya Hospital, Koshigaya. 6. Department of Neuroendovascular Therapy, Toranomon Hospital, Tokyo. 7. Department of Neurosurgery, Nagoya University, Nagoya. 8. Department of Stroke Neurology, Kyushu Medical Center, Fukuoka. 9. Department of Neurosurgery, Wakayama Rosai Hospital, Wakayama. 10. Department of Cardiology, Kokura Memorial Hospital, Kitakyushu. 11. Department of Neurosurgery, Hyogo Brain and Heart Center at Himeji, Himeji. 12. Department of Intravascular Neurosurgery, Konan Hospital, Sendai. 13. Division of Neuroendovascular Therapy, Institute of Biomedical Research and Innovation, Kobe.
Abstract
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.
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 stenosispatients 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.