Effects of MLC601 on Early Vascular Events in Patients After Stroke The CHIMES Study

Effects of MLC601 on Early Vascular Events in Patients After Stroke The CHIMES Study
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DOI：
10.1161/strokeaha.113.003226
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发表时间：
2013-12-01
期刊：
STROKE
影响因子：
8.3
通讯作者：
Bousser, Marie-Germaine
Bousser, Marie-Germaine
中科院分区：
医学1区
文献类型：
--
作者：
Chen, Christopher L. H.;Venketasubramanian, Narayanaswamy;Bousser, Marie-Germaine

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背景和目的早期血管事件是卒中后3个月内发病和死亡的重要原因。我们的目的是研究MLC 601对卒中发病3个月内早期血管事件发生的影响。方法对中国医学神经辅助剂对卒中恢复的疗效（CHIMES）研究中的受试者的数据进行事后分析，该研究是一项随机、安慰剂对照、一项在1099例在前72小时内发生中度缺血性卒中的受试者中比较MLC 601与安慰剂的双盲试验。早期血管事件定义为卒中发作3个月内发生的复发性卒中、急性冠脉综合征和血管性死亡的复合事件。结果3个月随访期间，MLC 601组的早期血管事件频率显著低于安慰剂组（16例[2.9%] vs 31例事件[5.6%];风险差异=-2.7%; 95%置信区间，-5.1%至-0.4%; P=0.025），非血管性死亡未增加。Kaplan-Meier生存分析显示，早在卒中后第一个月，两组之间的血管结局风险就存在差异（对数秩P=0.024;风险比，0.51; 95%置信区间，0.28-0.93）。这种影响的机制需要进一步研究。
Background and Purpose Early vascular events are an important cause of morbidity and mortality in the first 3 months after a stroke. We aimed to investigate the effects of MLC601 on the occurrence of early vascular events within 3 months of stroke onset.Methods Post hoc analysis was performed on data from subjects included in the CHInese Medicine Neuroaid Efficacy on Stroke recovery (CHIMES) study, a randomized, placebo-controlled, double-blinded trial that compared MLC601 with placebo in 1099 subjects with ischemic stroke of intermediate severity in the preceding 72 hours. Early vascular events were defined as a composite of recurrent stroke, acute coronary syndrome, and vascular death occurring within 3 months of stroke onset.Results The frequency of early vascular events during the 3-month follow-up was significantly less in the MLC601 group than in the placebo group (16 [2.9%] versus 31 events [5.6%]; risk difference=-2.7%; 95% confidence interval, -5.1% to -0.4%; P=0.025) without an increase in nonvascular deaths. Kaplan-Meier survival analysis showed a difference in the risk of vascular outcomes between the 2 groups as early as the first month after stroke (Log-rank P=0.024; hazard ratio, 0.51; 95% confidence interval, 0.28-0.93).Conclusions Treatment with MLC601 was associated with reduced early vascular events among subjects in the CHIMES study. The mechanisms for this effect require further study.