脑卒中外科治疗经典临床研究之三：MR CLEAN试验

急性缺血性卒中动脉内治疗随机临床试验
A Randomized Trial of Intraarterial Treatment for Acute Ischemic Stroke
背景：近端颅内动脉闭塞所致急性缺血性卒中患者的动脉内介入治疗是高效的急诊血运重建手段，但是目前仍缺乏功能预后获益的相关证据。
BACKGROUND In patients with acute ischemic stroke caused by a proximal intracranial arterial occlusion, intraarterial treatment is highly effective for emergency revascularization. However, proof of a beneficial effect on functional outcome is lacking.
方法：将符合入组标准的患者随机分为动脉内介入治疗联合常规药物治疗组和单纯常规药物治疗组。入组标准确定为起病6小时内，能够接受动脉内介入治疗，且经血管成像确诊为颅内前循环近端动脉闭塞的患者。主要研究终点确定为90天随访改良Rankin量表评分；该分类量表被用于评定功能预后，分值范围自0分（无症状）至6分（死亡）。应用有序Logistic回归分析计算总比值比，再经预先设定的预后因素校正后，进行疗效评价。使用校正后的总比值比评测动脉内介入治疗组改良Rankin量表评分低于常规药物治疗组的可能性（偏移分析）。
METHODS We randomly assigned eligible patients to either intraarterial treatment plus usual care or usual care alone. Eligible patients had a proximal arterial occlusion in the anterior cerebral circulation that was confirmed on vessel imaging and that could be treated intraarterially within 6 hours after symptom onset. The primary outcome was the modified Rankin scale score at 90 days; this categorical scale measures functional outcome, with scores ranging from 0 (no symptoms) to 6 (death). The treatment effect was estimated with ordinal logistic regression as a common odds ratio, adjusted for prespecified prognostic factors. The adjusted common odds ratio measured the likelihood that intraarterial treatment would lead to lower modified Rankin scores, as compared with usual care alone (shift analysis).
结果：本研究招募了荷兰16家医疗中心的500例患者；经随机分组，动脉内治疗组233例，常规药物治疗组267例。全组平均年龄65岁（23-96岁）；入组前接受过静脉注射阿替普酶治疗的患者445例，占89%。在动脉内介入治疗组233例患者中，使用可回收支架治疗者190例，占81.5%。校正后的总比值比为1.67（95%可信区间[CI]：1.21-2.30）。干预组患者功能独立（改良Rankin量表评分0-2分）的比例是32.6%，对照组为19.1%；两组绝对差达13.5个百分点（95% CI：5.9-21.2）。两组死亡率和症状性脑出血发生率无显著性差异。
RESULTS We enrolled 500 patients at 16 medical centers in the Netherlands (233 assigned to intraarterial treatment and 267 to usual care alone). The mean age was 65 years (range, 23 to 96), and 445 patients (89.0%) were treated with intravenous alteplase before randomization. Retrievable stents were used in 190 of the 233 patients (81.5%) assigned to intraarterial treatment. The adjusted common odds ratio was 1.67 (95% confidence interval [CI], 1.21 to 2.30). There was an absolute difference of 13.5 percentage points (95% CI, 5.9 to 21.2) in the rate of functional independence (modified Rankin score, 0 to 2) in favor of the intervention(32.6% vs. 19.1%). There were no significant differences in mortality or the occurrence of symptomatic intracerebral hemorrhage.

结论：对于颅内前循环近端血管闭塞所致急性缺血性卒中患者，起病6小时内给予动脉内介入治疗有效且安全。（本研究由荷兰心脏基金会和其他机构共同资助，MR CLEAN试验荷兰临床试验注册号：NTR1804，同期对照临床试验注册号：ISRCTN10888758。）
CONCLUSIONS In patients with acute ischemic stroke caused by a proximal intracranial occlusion of the anterior circulation, intraarterial treatment administered within 6 hours after stroke onset was effective and safe. (Funded by the Dutch Heart Foundation and others; MR CLEAN Netherlands Trial Registry number, NTR1804, and Current Controlled Trials number, ISRCTN10888758.)
原文出处：Berkhemer OA, Fransen PS, Beumer D, et al. A randomized trial of intraarterial treatment for acute ischemic stroke. N Engl J Med. 2015; 372(1): 11-20.