Efficacy and Safety of Combination Antiplatelet Therapies in Patients With Symptomatic Intracranial Atherosclerotic Stenosis
- 1 October 2011
- journal article
- research article
- Published by Ovid Technologies (Wolters Kluwer Health) in Stroke
- Vol. 42 (10), 2883-2890
- https://doi.org/10.1161/strokeaha.110.609370
Abstract
Background and Purpose—: An optimal strategy for management of symptomatic intracranial atherosclerotic stenosis (ICAS) has not yet been established. We compared the efficacy of 2 combinations of antiplatelets, aspirin plus cilostazol (cilostazol group) verus aspirin plus clopidogrel (clopidogrel group), on the progression of ICAS, which is known to be associated with clinical stroke recurrence. Methods—: In this investigator-initiated double-blind trial, 457 patients with acute symptomatic stenosis in the M1 segment of the middle cerebral artery or the basilar artery were randomly allocated into either a cilostazol group or a clopidogrel group. After 7 months of treatment, follow-up MR angiogram and MRI were performed. The primary end point was the progression of ICAS in comparison with stenosis on the baseline MR angiogram. Secondary end points included the occurrence of new ischemic lesions on MRI, composite of cardiovascular events, and major bleeding complications. Results—: Cardiovascular events occurred in 15 of 232 patients (6.4%) in the cilostazol group and 10 of 225 (4.4%) in the clopidogrel group ( P =0.312). Cilostazol did not reduce the progression of symptomatic ICAS (20 of 202) compared to clopidogrel (32 of 207) (odds ratio, 0.61; P =0.092), although favorable changes in serum lipoproteins were observed in the cilostazol group. There were no significant differences between the 2 groups with respect to new ischemic lesions (18.7% versus 12.0%; P =0.078) and major hemorrhagic complications (0.9% versus 2.6%; P =0.163). Conclusions—: This trial failed to show significant difference in preventing progression of ICAS and new ischemic lesions between the 2 combination antiplatelet therapies in the patients with symptomatic ICAS. Clinical Trial Registration—: URL: http://www.clinicaltrials.gov . Unique identifier: NCT00130039.Keywords
This publication has 27 references indexed in Scilit:
- Bleeding Complications With Dual Antiplatelet Therapy Among Patients With Stable Vascular Disease or Risk Factors for Vascular DiseaseCirculation, 2010
- Large Artery Intracranial Occlusive DiseaseStroke, 2008
- The Stroke Outcomes and Neuroimaging of Intracranial Atherosclerosis (SONIA) TrialNeurology, 2007
- Predictors of Ischemic Stroke in the Territory of a Symptomatic Intracranial Arterial StenosisCirculation, 2006
- Coronary Stent Restenosis in Patients Treated With CilostazolCirculation, 2005
- Dual Antiplatelet Therapy With Clopidogrel and Aspirin in Symptomatic Carotid Stenosis Evaluated Using Doppler Embolic Signal DetectionCirculation, 2005
- Cilostazol Prevents the Progression of the Symptomatic Intracranial Arterial StenosisStroke, 2005
- Effects of statin therapy on the progression of carotid atherosclerosis: a systematic review and meta-analysisAtherosclerosis, 2004
- Aspirin and clopidogrel compared with clopidogrel alone after recent ischaemic stroke or transient ischaemic attack in high-risk patients (MATCH): randomised, double-blind, placebo-controlled trialThe Lancet, 2004
- Reduction of remnant lipoprotein cholesterol concentrations by cilostazol in patients with intermittent claudicationAtherosclerosis, 2003