Cilostazol prevents the progression of the symptomatic intracranial arterial stenosis - The Multicenter double-blind placebo-controlled trial of cilostazol in symptomatic intracranial arterial stenosis

Cilostazol prevents the progression of the symptomatic intracranial arterial stenosis - The Multicenter double-blind placebo-controlled trial of cilostazol in symptomatic intracranial arterial stenosis
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DOI:
10.1161/01.str.0000157667.06542.b7
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发表时间:
2005-04-01
期刊:
影响因子:
8.3
通讯作者:
Kim, JS
Kim, JS
中科院分区:
医学1区
文献类型:
--
作者:
Kwon, SU;Cho, YJ;Kim, JS

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背景和目的-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植入术后的再狭窄率。本研究旨在探讨西洛他唑对颅内动脉狭窄(IAS)进展的影响。方法:我们将135例大脑中动脉或基底动脉M1段急性症状性狭窄患者随机分为西洛他唑200 mg/天组和安慰剂组,为期6个月。所有患者均给予阿司匹林100 mg/d。排除了心脏或颅外动脉中存在潜在栓塞源的患者。在招募时和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和次要结局的症状IAS的进展是临床事件和进展TCD.Results -38例患者提前终止。西洛他唑组和安慰剂组的脱落率和脱落原因相似。西洛他唑组和安慰剂组均无卒中复发,但各组均发生1例死亡和2例冠状动脉事件。西洛他唑组45例症状性IAS中3例(6.7%)进展,11例(24.4%)消退。在安慰剂组中,15例(28.8%)症状性IAS进展,8例(15.4%)消退。西洛他唑组症状性IAS的进展明显低于安慰剂组(P = 0.008)。结论:症状性IAS是一种动态损害,西洛他唑可阻止其进展。
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.