急性缺血性脑卒中的动脉内治疗随机试验。

A randomized trial of intraarterial treatment for acute ischemic stroke.

机构信息

The authors' affiliations are listed in the Appendix.

出版信息

N Engl J Med. 2015 Jan 1;372(1):11-20. doi: 10.1056/NEJMoa1411587. Epub 2014 Dec 17.

DOI:10.1056/NEJMoa1411587

PMID:25517348

Abstract

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.

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).

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.

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.).

摘要

背景

在因近端颅内动脉闭塞导致急性缺血性脑卒中的患者中，动脉内治疗对于紧急血管再通非常有效。然而，其对功能结局的有益影响尚无定论。

方法

我们将符合条件的患者随机分配至动脉内治疗加常规治疗组或单纯常规治疗组。符合条件的患者在前循环近端动脉闭塞，在血管成像上得到证实，并且可以在症状发作后 6 小时内进行动脉内治疗。主要结局是 90 天时改良 Rankin 量表评分；该分类量表衡量功能结局，评分范围为 0（无症状）至 6（死亡）。采用有序逻辑回归作为共同比值比来估计治疗效果，同时调整了预设的预后因素。调整后的共同比值比衡量了与单纯常规治疗相比，动脉内治疗导致改良 Rankin 评分降低的可能性（移位分析）。

结果

我们在荷兰的 16 家医疗中心纳入了 500 名患者（233 名分配至动脉内治疗组，267 名分配至单纯常规治疗组）。患者平均年龄为 65 岁（范围为 23 岁至 96 岁），445 名患者（89.0%）在随机分组前接受了静脉内阿替普酶治疗。233 名分配至动脉内治疗组的患者中有 190 名（81.5%）使用了可回收支架。干预组功能独立性（改良 Rankin 评分 0 至 2）的比率为 32.6%，而对照组为 19.1%，优势比为 1.67（95%置信区间[CI]，1.21 至 2.30），有 13.5 个百分点（95%CI，5.9 至 21.2）的绝对差异有利于干预措施。死亡率或症状性颅内出血的发生率无显著差异。