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(Stroke. 2005;36:782.)
© 2005 American Heart Association, Inc.

Original Contributions

Cilostazol Prevents the Progression of the Symptomatic Intracranial Arterial Stenosis

The Multicenter Double-Blind Placebo-Controlled Trial of Cilostazol in Symptomatic Intracranial Arterial Stenosis

Sun U. Kwon, MD, PhD; Yong-Jin Cho, MD, PhD; Ja-Seong Koo, MD; Hee-Joon Bae, MD, PhD; Yong-Seok Lee, MD; Keun-Sik Hong, MD, PhD; Jun Hong Lee, MD Jong S. Kim, MD, PhD

From the Department of Neurology (S.U.K., J.S.K.), Asan Medical Center, University of Ulsan, College of Medicine, Seoul, Korea; the Department of Neurology (Y.-J.C., K.-S.H.), Inje University, Ilsan Paik Hospital, Gyeonggido, Korea; the Department of Neurology (J.-S.K., H.-J.B.), Eulji General Hospital, Eulji University, Seoul, Korea; the Department of Neurology (Y.-S.L.), Seoul Municipal Boramae Hospital, Seoul National University, Seoul, Korea; and the Department of Neurology (J.H.L.), National Health Insurance Corporation Ilsan Hospital, Gyeonggido, Korea.

Correspondence to Dr Sun U. Kwon, Department of Neurology, Asan Medical Center, University of Ulsan, College of Medicine, Seoul, Korea, 138-736. E-mail sunuck{at}amc.seoul.kr

Background and Purpose— Cilostazol, a phosphodiesterase inhibitor, has been reported to reduce restenosis rate after coronary angioplasty and stenting. This study was performed to investigate the effect of cilostazol on the progression of intracranial arterial stenosis (IAS).

Methods— We randomized 135 patients with acute symptomatic stenosis in the M1 segment of middle cerebral artery or the basilar artery to either cilostazol 200 mg per day or placebo for 6 months. Aspirin 100 mg per day was also given to all patients. Patients with potential embolic sources in the heart or extracranial arteries were excluded. IAS was assessed by magnetic resonance angiogram (MRA) and transcranial Doppler (TCD) at the time of recruitment and 6 months later. The primary outcome was the progression of symptomatic IAS on MRA and secondary outcomes were clinical events and progression on TCD.

Results— Thirty-eight patients were prematurely terminated. Dropout rates and reasons for dropouts were similar between the cilostazol and placebo groups. There was no stroke recurrence in either cilostazol or placebo group, but there was 1 death and 2 coronary events in each group. In cilostazol group, 3 (6.7%) of 45 symptomatic IAS progressed and 11 (24.4%) regressed. In placebo group, 15 (28.8%) of symptomatic IAS progressed and 8 (15.4%) regressed. Progression of symptomatic IAS in cilostazol group was significantly lower than that in placebo group (P=0.008)

Conclusion— Our study suggests that symptomatic IAS is a dynamic lesion and cilostazol may prevent its progression.

Key Words: atherosclerosis • cerebrovascular disorders • magnetic resonance angiography

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