Abstract 2782: Prospective Multicenter Study On Prevention Using Cilostazol From Acute Stroke Progression: Kumamoto Pentagon Study
Background and purpose: About 20% of patients with acute ischemic stroke experience symptom progression resulting in poor outcome. We have evaluated the effect of cilostazol compared with aspirin on preventing acute symptom progression, and on clinical outcome.
Methods: A multi-center, open, randomized, prospective comparative study conducted from April 2009 to March 2011. Inclusion criteria: non-cardioembolic ischemic stroke admitted within 48 hours of onset, neurologically stable, and with written informed consent. Exclusion criteria: contraindicated or previous exposure to aspirin and/or cilostazol. Patients were administered either cilostazol 200 mg daily (group C) or aspirin 200 mg daily (group A) within 48 hours of onset. Primary endpoint: occurrence of acute symptom progression (ΔNIHSS ≥2) within 7 days. Secondary endpoints: 3-month outcome (mRS 0-2), occurrence of vascular events (ischemic stroke, brain hemorrhage, myocardial infarction), bleeding events, and other adverse events. UMIN Clinical Trial ID: UMIN000004016.
Results: In total, 209 patients (126 men, 71.2 years, NIHSS median 3) were recruited. After excluding 11 patients with a final diagnosis of cardioembolic stroke or stroke mimics, 104 and 94 patients were allocated to group C and group A, respectively. No statistical differences in clinical backgroud were observed between the groups. Acute symptom progression was observed 10 patients each in group C (9.6%) and group A (10.6%) (n.s). mRS 0-2 at 3 months was achieved in 84.4% (54/64) of group C and 69.1% (38/65) of group A (p=0.07). Subgroup analysis showed that patients with small vessel occlusion (preictal mRS ≤2, n=80) had better clinical outcome with cilostazol (p=0.03). No vascular or bleeding events occurred except for one intraabdominal bleed in group C. One patient in group C experienced headache. Liver dysfunction was reported one each patient in groups A and C.
Conclusions: Effect of cilostazol on preventing symptom progression was comparable with that of aspirin. Cilostazol is one option for acute stroke therapy, especially for patients with small vessel occlusion.
- © 2012 by American Heart Association, Inc.