Cilostazol prevents the progression of the symptomatic intracranial arterial stenosis: the multicenter double-blind placebo-controlled trial of cilostazol in symptomatic intracranial arterial stenosis.
OBJECTIVE
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)


CONCLUSIONS
Our study suggests that symptomatic IAS is a dynamic lesion and cilostazol may prevent its progression.
Kwon
Sun U
SU
Department of Neurology, Asan Medical Center, University of Ulsan, College of Medicine, Seoul, Korea. sunuck@amc.seoul.kr
Cho
Yong-Jin
YJ
Koo
Ja-Seong
JS
Bae
Hee-Joon
HJ
Lee
Yong-Seok
YS
Hong
Keun-Sik
KS
Lee
Jun Hong
JH
Kim
Jong S
JS
D000368:Aged; D000792:Angiography; D001158:Arteries / Q000473:pathology*; D001241:Aspirin / Q000494:pharmacology; D001921:Brain / Q000098:blood supply*; D000077407:Cilostazol; D003251:Constriction, Pathologic / Q000188:drug therapy* / Q000517:prevention & control; D018450:Disease Progression; D004311:Double-Blind Method; D005500:Follow-Up Studies; D006801:Humans; D020244:Infarction, Middle Cerebral Artery / Q000175:diagnosis*; D008279:Magnetic Resonance Imaging; D008297:Male; D018696:Neuroprotective Agents / Q000627:therapeutic use*; D010726:Phosphodiesterase Inhibitors / Q000627:therapeutic use*; D010919:Placebos; D012680:Sensitivity and Specificity; D013777:Tetrazoles / Q000627:therapeutic use*; D013997:Time Factors; D016896:Treatment Outcome
D018696:Neuroprotective Agents; D010726:Phosphodiesterase Inhibitors; D010919:Placebos; D013777:Tetrazoles; D000077407:Cilostazol; D001241:Aspirin