Endovascular treatment for medium or distal vessel occlusion stroke (DISTAL): 12-month outcomes of a multicentre, open-label, randomised trial.

Three out of four randomised trials reported no benefit of endovascular treatment over best medical treatment at 90 days.

四项随机试验中有三项报告，在90天时血管内治疗与最佳药物治疗相比没有优势。

We aimed to assess efficacy of endovascular treatment plus best medical treatment versus best medical treatment alone at 12 months in patients enrolled in the DISTAL trial, as well as overall survival.

我们的目标是在DISTAL试验中评估接受血管内治疗加最佳药物治疗与仅接受最佳药物治疗的患者在12个月时的疗效，以及总生存。

Methods

DISTAL was an open-label, randomised trial with blinded endpoint assessment conducted at 55 hospitals in Europe and the Middle East.

DISTAL是一项在欧洲和中东55家医院进行的开放标签、随机试验，终点评估为盲法。

Adults (≥18 years) with acute ischaemic stroke due to medium or distal vessel occlusion (occlusion of co-dominant or non-dominant M2 or M3-M4 middle cerebral artery, A1-A3 anterior cerebral artery, or P1-P3 posterior cerebral artery) presenting from home within 6 h of last known well, or between 6 h and 24 h if neuroimaging demonstrated potentially salvageable tissue, were randomly assigned (1:1) through a centralised web-based system to endovascular treatment plus best medical treatment or best medical treatment alone.

成年患者（≥18岁）因中段或远端血管闭塞（共优势或非优势M2段或M3-M4中脑动脉、A1-A3前脑动脉或P1-P3后脑动脉闭塞）导致的急性缺血性中风，在最后已知良好状态后6小时内从家中到达，或如果神经影像学显示有潜在可挽救的组织，在6小时至24小时之间，通过中心化的基于网络的系统随机分配（1:1）接受血管内治疗加最佳药物治疗或仅最佳药物治疗。

The prespecified primary outcome at 12 months was disability measured by use of the ordinal modified Rankin Scale (mRS; scores 5 and 6 combined) in the intention-to-treatpopulation.

12个月时的预设主要结局指标是通过使用序数改良Rankin量表（mRS；将5和6分合并）测量的残疾，在意向治疗人群中。

The only safety outcome was overall survival. The trial is registered on ClinicalTrials.gov (NCT05029414) and is completed.

唯一的安全性结果是总生存。该试验已在ClinicalTrials.gov上注册（NCT05029414），并已完成。

Results

Between Dec 16, 2021, and July 10, 2024, we enrolled 553 patients.

从2021年12月16日到2024年7月10日，我们共招募了553名患者。

Ten patients declined post-hoc consent, leaving 543 participants in the analysis (239 [44%] females and 304 [56%] males; median age 77 years, IQR 68-84). 271 (50%) were assigned to endovascular treatment plus best medical treatment and 272 (50%) to best medical treatment alone.

十名患者拒绝了事后的同意，分析中剩余543名参与者（239名[44%]女性和304名[56%]男性；中位年龄77岁，四分位数间距68-84）。271名（50%）被分配到血管内治疗加最佳药物治疗组，另外272名（50%）仅接受最佳药物治疗。

The median NIHSS score at admission was 6 (IQR 5-9); 355 (65%) participants received intravenous thrombolysis.

入院时的NIHSS评分中位数为6（四分位数间距5-9）；355名（65%）参与者接受了静脉溶栓治疗。

Predominant occlusion locations were the M2 (239 [44%]), M3 (146 [27%]), P2 (73 [13%]), and P1 (30 [6%]) segments. 12-month data were available for 524 (97%) participants.

主要闭塞位置是M2段（239例，占44%）、M3段（146例，占27%）、P2段（73例，占13%）和P1段（30例，占6%）。524名（97%）参与者有12个月的数据可用。

The median mRS score was 2 (IQR 1-4) in the endovascular treatment plus best medical treatment group and 2 (1-4) in the best medical treatment alone group.

在血管内治疗加最佳药物治疗组中，中位数mRS评分为2（四分位数间距1-4），而在仅接受最佳药物治疗组中，中位数mRS评分为2（四分位数间距1-4）。

There was no difference in 12-month mRS distribution between endovascular treatment plus best medical treatment and best medical treatment alone (adjusted common odds ratio for better functional outcome 0·81, 95% CI 0·59-1·12; p=0·20).

在血管内治疗加最佳药物治疗与仅最佳药物治疗之间，12个月改良Rankin量表（mRS）分布没有差异（调整后的共同比值比为更好的功能结果0.81，95%置信区间0.59-1.12；p=0.20）。

Overall survivalwas similar between the two groups (hazard ratio1·46, 95% CI 0·93-2·30; p=0·10).

两组之间的总生存率相似（风险比1.46，95%置信区间0.93-2.30；p=0.10）。

interpretation

In patients with a medium or distal vessel occlusion stroke, endovascular treatment plus best medical treatment was not associated with a reduction of disability or death at 12 months compared with best medical treatment.

在中段或远端血管闭塞型卒中患者中，血管内治疗加最佳药物治疗与单纯最佳药物治疗相比，并未在12个月时降低残疾或死亡率。

These results are consistent with the 90-day results.

这些结果与90天的结果一致。

Routine endovascular treatment is therefore not supported for patients with mild-to-moderate medium or distal vessel occlusion stroke.

因此，对于轻度至中度中段或远端血管闭塞的卒中患者，不支持常规进行血管内治疗。

funding

Swiss National Science Foundation, Gottfried und Julia Bangerter-Rhyner-Foundation, Medtronic, Stryker Neurovascular, Phenox, Rapid Medical, and Penumbra.

瑞士国家科学基金会、Gottfried und Julia Bangerter-Rhyner基金会、美敦力、Stryker神经血管、Phenox、Rapid Medical和Penumbra。