氯吡格雷联合阿司匹林治疗对轻型卒中与短暂性脑缺血发作患者功能预后的影响:CHANCE与POINT试验联合分析

Effect of Clopidogrel plus Aspirin Therapy on Functional Outcome in Minor Stroke or Transient Ischemic Attack:Pooled Analysis of CHANCE and POINT

目的评价氯吡格雷联合阿司匹林双抗治疗对轻型缺血性卒中与TIA患者功能预后的影响。方法提取CHANCE和POINT试验所有的个体数据。这两项试验中,所有纳入患者在症状发作12 h(POINT)或24 h(CHANCE)以内随机接受氯吡格雷联用阿司匹林或单用阿司匹林治疗。结局指标为3个月时功能预后不良(mRS≥2),三等级定义卒中复发[致残性或致死性卒中复发(mRS≥2)、非致残性卒中复发(mRS 0或1)、无卒中复发]。结果共10013例患者纳入分析,其中来自CHANCE试验5132例(51.3%),来自POINT试验4881例(48.7%);氯吡格雷联用阿司匹林组4995例(49.9%),单用阿司匹林组5018例(50.1%)。氯吡格雷联用阿司匹林组3个月时功能预后不良的患者比例低于单用阿司匹林组(11.6%vs 12.6%,校正OR 0.82,95%CI 0.72~0.94,P=0.005)。氯吡格雷联用阿司匹林组致残性或致死性卒中复发(4.6%vs 6.1%,校正OR 0.73,95%CI 0.61~0.87,P<0.001)、非致残性卒中复发(1.9%vs 3.0%,校正OR 0.62,95%CI 0.47~0.80,P<0.001)和卒中复发的整体致残性(校正cOR 0.70,95%CI 0.60~0.81,P<0.001)低于单用阿司匹林组。结论与单用阿司匹林治疗相比,氯吡格雷联用阿司匹林治疗可进一步改善轻型缺血性卒中和TIA患者3个月时功能预后,减少致残性卒中复发。

Objective To evaluate the effect of clopidogrel plus aspirin dual antiplatelet therapy on functional outcome in patients with minor stroke or TIA.Methods Individual patient-level data from the CHANCE and POINT trial were extracted and pooled.In the 2 trials,the patients were randomly given clopidogrel plus aspirin or aspirin alone within 12 hours(POINT)or 24 hours(CHANCE)from symptom onset.The main outcome were poor functional outcome(mRS≥2),and 3-level ordinal stroke scale[classified as disabling or fatal recurrent stroke(mRS≥2),nondisabling recurrent stroke(mRS 0 or 1)and no recurrent stroke].Results This analysis included individual data from 10013 patients,of which 5132 patients(51.3%)were derived from the CHANCE trial and 4881(48.7%)were derived from the POINT trial,with 4995(49.9%)cases were in clopidogrel plus aspirin group and 5018(50.1%)were in aspirin alone group.The proportion of patients with poor functional outcome at 3 months in clopidogrel plus aspirin group was lower than that in aspirin alone group(11.6%vs 12.6%,adjusted OR 0.82,95%CI 0.72-0.94,P=0.005).Compared with the aspirin alone group,the dual antiplatelet therapy group also had lower risk of disabling or fatal recurrent stroke(4.6%vs 6.1%,adjusted OR 0.73,95%CI 0.61-0.87,P<0.001),nondisabling recurrent stroke(1.9%vs 3.0%,adjusted OR 0.62,95%CI 0.47-0.80,P<0.001)and the overall disability for recurrent stroke(adjusted common OR 0.70,95%CI 0.60-0.81,P<0.001).Conclusions Compared to aspirin alone,clopidogrel plus aspirin dual antiplatelet therapy can further improved functional outcome and reduced disabling recurrent stroke at 3 months in patients with minor ischemic stroke or TIA.