Effect of Combined Aspirin and Extended-Release Dipyridamole Versus Clopidogrel on Functional Outcome and Recurrence in Acute, Mild Ischemic Stroke PRoFESS Subgroup Analysis
Effect of Combined Aspirin and Extended-Release Dipyridamole Versus Clopidogrel on Functional Outcome and Recurrence in Acute, Mild Ischemic Stroke PRoFESS Subgroup Analysis
复制标题
DOI：
10.1161/strokeaha.109.564906
复制
发表时间：
2010-04-01
期刊：
影响因子：
8.3
通讯作者：
Roberts, Robin
中科院分区：
文献类型：
--
作者：
Bath, Philip M. W.;Cotton, Daniel;Roberts, Robin
背景和目的--长期抗血小板治疗在减少缺血性卒中后复发方面是有效的。然而，阿司匹林-双嘧达莫或氯吡格雷在急性缺血性中风患者中的相对安全性和有效性尚不清楚。方法：析因式二级预防试验评估了20332名患者的抗血小板和降压策略，其中1360人在缺血性中风后72小时内随机接受阿司匹林(25 mg，2次/d)和缓释剂双嘧达莫(ER-DP，200 mg，2次/d，n=672)或氯吡格雷(75 mg/d，n=688)治疗。这项特殊分组后分析的主要结果是30天后的功能结果；次要结果包括90天前的复发和死亡。分析调整了基线预后变量和血压治疗分配。结果：患者具有整个试验的代表性(年龄67岁，美国国立卫生研究院卒中评分3分，小动脉闭塞59%)，治疗组之间基线变量相似。从中风到招募的平均时间为58小时。到90天时，121名(18%)接受Asp/ER-DP治疗的患者和86名(12.5%)接受氯吡格雷治疗的患者不再接受治疗(P=0.006)。合并死亡或依赖(第30天改良Rankin量表评分的转移分析)在治疗组之间没有差异(优势比[OR]=0.97；95%CI，0.79至1.19)。Asp/ER-DP无明显减少复发(OR=0.56；95%CI，0.26~1.18)和血管事件(OR=0.71；95%CI，0.36~1.37)的趋势。不同治疗组的死亡率、大出血和严重不良事件发生率没有差异。结论：在1360例急性、轻度缺血性卒中患者中，Asp/ER-DP联合治疗与氯吡格雷治疗对功能结局、复发、死亡、出血或严重不良事件的影响没有差异。这两种治疗方法都很实用。(笔划。2010；41：732-738。)
Background and Purpose-Long-term antiplatelet therapy is effective at reducing recurrence after ischemic stroke. However, the relative safety and efficacy of combined aspirin-dipyridamole or clopidogrel are not known in patients with acute ischemic stroke.Methods-The factorial PRoFESS secondary prevention trial assessed antiplatelet and blood pressure-lowering strategies in 20 332 patients, 1360 of whom were randomized within 72 hours of ischemic stroke to combined aspirin (Asp; 25 mg BID) and extended-release dipyridamole (ER-DP; 200 mg BID, n=672) or clopidogrel (75 mg/d, n=688). The primary outcome for this post hoc subgroup analysis was functional outcome at 30 days; secondary outcomes included recurrence and death by 90 days. Analyses were adjusted for baseline prognostic variables and blood pressure treatment assignment.Results-Patients were representative of the whole trial (age 67 years, National Institutes of Health Stroke Scale score 3, small-artery occlusion 59%), and baseline variables were similar between treatment groups. The mean time from stroke to recruitment was 58 hours. By 90 days, treatment was no longer being taken in 121 (18%) patients randomized to Asp/ER-DP and in 86 (12.5%) assigned to clopidogrel (P=0.006). Combined death or dependency (shift analysis of modified Rankin Scale score at day 30) did not differ between treatment groups (odds ratio [OR]=0.97; 95% CI, 0.79 to 1.19). Nonsignificant trends to reduced recurrence (OR=0.56; 95% CI, 0.26 to 1.18) and vascular events (OR=0.71; 95% CI, 0.36 to 1.37) were present with Asp/ER-DP. Rates of death, major bleeding, and serious adverse events did not differ between treatment groups.Conclusions-Treatment with combined Asp/ER-DP vs clopidogrel in 1360 patients with acute, mild ischemic stroke did not differ in terms of effects on functional outcome, recurrence, death, bleeding, or serious adverse events. Both treatments were practical to administer. (Stroke. 2010; 41: 732-738.)