Abstract WP423: Final Results of Cilostazol-Aspirin Therapy Against Recurrent Stroke with Intracranial Artery Stenosis (CATHARSIS)

Abstract

Background: The Cilostazol-Aspirin Against Recurrent Stroke with Intracranial Artery Stenosis (CATHARSIS) (Clinicaltrials.gov identifier: NCT 00333164) was a randomized controlled trial to compare cilostazol plus aspirin with aspirin alone in patients with symptomatic intracranial artery stenosis (IAS). We presented final results of CATHARSIS. Methods: Subjects were patients at age of 45-85 years with ischemic stroke after two weeks to six months from onset and >50% stenosis in responsible intracranial arteries on MRA. They were randomly allocated either group of cilostazol 200 mg/day plus aspirin 100 mg/day (CA group) or aspirin 100 mg/day alone (A group), who were followed up for two years. Primary endpoint was progression of IAS after two years. Secondary endopoints included ischemic stroke, all strokes, all vascular events (ischemic stroke, MI, and other vascular events) and new silent brain infarcts. Results: A total of 165 patients (109 males, average 68 years) were randomized. Male (77.1% vs 53.8%), hypertension (83.1% vs 68.8%), and diabetes (48.2% vs 25.0%) were more frequent in CA than A group. There was no difference in the progression of IAS between both groups (9.6% [95 CI 3.9-18.8%] in CA group and 7.6% [95% CI 3.8-13.2%] in A group, p = 0.5326). Stroke recurrence occurred in 2.4%/year in CA group (ischemic 4, hemorrhagic 0) and 5.5%/year in A group (ischemic 6, hemorrhagic 2). Rate of stroke recurrence tended to be lower in CA than C group (adjusted HR 0.439, 95% CI 0.112-1.497, p = 0.191). Rate of vascular events also tended to be lower in CA than A group (adjusted HR 0.390, 95% CI 0.118-1.136, p = 0.085). New silent brain infarcts were observed in 4.8% in CA group and 10.0% in A group at two years (p = 0.2445). Conclusion: Rates of IAS progression and recurrent stroke were unexpectedly low in both treatment groups, which could be due to excellent medical management and have reduced statistical power. There was no difference in the progression of IAS between two groups. Rates of stroke recurrence, vascular events, and new silent brain infarcts tended to be lower in CA than A group.