Abstract T P338: To Evaluate the Efficacy and Safety of Cilostazol in Ischemic Stroke Patients with Peripheral Arterial Disease (SPAD) Study: Methodology and Baseline Data
Background and Purpose: Ischemic stroke often co-exists with peripheral arterial disease (PAD). Patients with polyvascular diseases carry higher risks of vascular events and death. We initiated a study to evaluate the safety and efficacy of cilostazol in ischemic Stroke patients with PAD (SPAD) and have been taking aspirin for stroke prevention.
Methods: The SPAD study is a prospective, multicenter, national, double-blinded, placebo-controlled, randomized trial. Patients with previous ischemic stroke or TIA who have been taking aspirin (100 mg per day), aged 50 years or older, with PAD in the lower limbs based on ankle-brachial index (ABI) <1.0 were randomized to the treatment group with cilostazol (200 mg/day) or the placebo group with a 1:1 basis. Each patient is periodically followed-up for one year. The primary endpoint of the study is the change in the ABI. The secondary endpoints are the change in the common carotid artery intima-media thickness (IMT); major cardiovascular events, including recurrent stroke, myocardial infarction, unstable angina, other vascular events, and all death; and the safety, including major bleeding events, hemorrhagic stroke, and any death.
Results: From September, 2010 to July, 2012, a total of 800 patients (male, 59.9%; female, 40.1%; average age, 70.4±9.3 years) were enrolled in the SPAD study, including 722 (90.2%) with ischemic stroke or 78 (9.8%) with TIA. Several atherosclerotic risk factors were commonly seen in this study population, including hypertension (88%), diabetes mellitus (48%), hypercholesterolemia (54%), smoking habit (41%), and carotid stenosis (15%). The distribution of baseline ABI were 0.90-0.99 (n=294), 0.70-0.89 (n=371), and <0.70 (n=136). Patients with lower ABI were more frequently associated with old age, lower body mass index, smoking habit, diabetes mellitus, carotid stenosis ≥50%, and higher systolic blood pressure.
Conclusions: The SPAD trial is the first study to evaluate the safety and efficacy of dual antiplatelets, aspirin plus cilostazol, in ischemic stroke patients with PAD. The trial findings are expected to help in choosing better strategy for prevention of vascular events in this polyvascular disease.
Author Disclosures: J. Jeng: None. L. Lien: None. S. Chen: None. C. Hsu: None.
- © 2014 by American Heart Association, Inc.