Kwon Sun U, Cho Yong-Jin, Koo Ja-Seong, Bae Hee-Joon, Lee Yong-Seok, Hong Keun-Sik, Lee Jun Hong, Kim Jong S
Department of Neurology, Asan Medical Center, University of Ulsan, College of Medicine, Seoul, Korea.
Stroke. 2005 Apr;36(4):782-6. doi: 10.1161/01.STR.0000157667.06542.b7. Epub 2005 Mar 3.
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).
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.
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)
Our study suggests that symptomatic IAS is a dynamic lesion and cilostazol may prevent its progression.
西洛他唑是一种磷酸二酯酶抑制剂,据报道可降低冠状动脉血管成形术和支架置入术后的再狭窄率。本研究旨在探讨西洛他唑对颅内动脉狭窄(IAS)进展的影响。
我们将135例大脑中动脉M1段或基底动脉急性症状性狭窄患者随机分为两组,一组每天服用200毫克西洛他唑,另一组服用安慰剂,为期6个月。所有患者每天还服用100毫克阿司匹林。排除心脏或颅外动脉有潜在栓子来源的患者。在入组时和6个月后,通过磁共振血管造影(MRA)和经颅多普勒(TCD)评估IAS。主要结局是MRA上有症状的IAS进展情况,次要结局是临床事件和TCD上的进展情况。
38例患者提前终止研究。西洛他唑组和安慰剂组的退出率及退出原因相似。西洛他唑组和安慰剂组均未发生中风复发,但每组各有1例死亡和2例冠状动脉事件。在西洛他唑组,45例有症状的IAS中3例(6.7%)进展,11例(24.4%)好转。在安慰剂组,有症状的IAS中15例(28.8%)进展,8例(15.4%)好转。西洛他唑组有症状的IAS进展明显低于安慰剂组(P=0.008)。
我们的研究表明,有症状的IAS是一种动态病变,西洛他唑可能会阻止其进展。