血管内与内科治疗急性基底动脉闭塞的对比：一项随机临床试验的二次分析。

Endovascular vs Medical Management of Acute Basilar Artery Occlusion: A Secondary Analysis of a Randomized Clinical Trial.

机构信息

Department of Neurology, The First Affiliated Hospital of USTC, Division of Life Sciences and Medicine, University of Science and Technology of China, Hefei, China.

Department of Neurology, Linyi People's Hospital, Linyi, China.

出版信息

JAMA Neurol. 2024 Oct 1;81(10):1043-1050. doi: 10.1001/jamaneurol.2024.2652.

DOI:10.1001/jamaneurol.2024.2652

PMID:39186280

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11348088/

Abstract

IMPORTANCE

In several randomized clinical trials, endovascular thrombectomy led to better functional outcomes than conventional treatment at 90 days poststroke in patients with acute basilar artery occlusion. However, the long-term clinical outcomes of these patients have not been well delineated.

OBJECTIVE

To evaluate 1-year clinical outcomes in patients with acute basilar artery occlusion following endovascular thrombectomy vs control.

DESIGN, SETTING, AND PARTICIPANTS: This study is an extension of the ATTENTION trial, a multicenter, randomized clinical trial. Patients were included between February 2021 and January 2022, with 1-year follow-up through April 2023. This multicenter, population-based study was conducted at 36 comprehensive stroke sites. Patients with acute basilar artery occlusion within 12 hours of estimated symptom onset were included. Of the 342 patients randomized in the ATTENTION trial, 330 (96.5%) had 1-year follow-up information available.

EXPOSURES

Endovascular thrombectomy (thrombectomy group) vs best medical treatment (control group).

MAIN OUTCOMES AND MEASURES

The primary outcome was defined as a score of 0 to 3 on the modified Rankin Scale (mRS) at 1 year. Secondary outcomes were functional independence (mRS score 0-2), excellent outcome (mRS score 0-1), level of disability (distribution of all 7 mRS scores), mortality, and health-related quality of life at 1 year.

RESULTS

Among 330 patients who had 1-year follow-up data, 227 (68.8%) were male, and the mean (SD) age was 67.0 (10.7) years. An mRS score 0 to 3 at 1 year was achieved by 99 of 222 patients (44.6%) in the thrombectomy group and 21 of 108 (19.4%) in the control group (adjusted rate ratio, 2.23; 95% CI, 1.51-3.29). Mortality at 1 year compared with 90 days was more frequent in both the thrombectomy group (101 of 222 [45.5%] vs 83 of 226 [36.7%]) and the control group (69 of 108 [63.9%] vs 63 of 114 [55.3%]). Excellent outcome (mRS score 0-1) at 1 year compared with 90 days increased in the thrombectomy group (62 of 222 [27.9%] vs 45 of 226 [19.9%]) but not in the control group (9 of 108 [8.3%] vs 9 of 114 [7.9%]) resulting in a magnified treatment benefit.

CONCLUSIONS AND RELEVANCE

Among patients with basilar artery occlusion within 12 hours of onset, the benefits of endovascular thrombectomy at 1 year compared with 90 days were sustained for favorable (mRS score 0-3) outcome and enhanced for excellent (mRS score 0-1) outcome.

摘要

重要性

在几项随机临床试验中，与传统治疗相比，血管内血栓切除术在急性基底动脉闭塞的患者中在 90 天后导致更好的功能结局。然而，这些患者的长期临床结局尚未得到很好的描述。

目的

评估急性基底动脉闭塞患者血管内血栓切除术与对照组相比的 1 年临床结局。

设计、地点和参与者：这项研究是 ATTENTION 试验的扩展，是一项多中心随机临床试验。2021 年 2 月至 2022 年 1 月期间入组患者，2023 年 4 月进行 1 年随访。这项多中心、基于人群的研究在 36 个综合卒中站点进行。纳入起病后 12 小时内急性基底动脉闭塞的患者。在 ATTENTION 试验中随机分组的 342 例患者中，有 330 例（96.5%）有 1 年随访信息。

暴露

血管内血栓切除术（血栓切除术组）与最佳药物治疗（对照组）。

主要结局和测量指标

主要结局定义为 1 年时改良 Rankin 量表（mRS）评分为 0 至 3。次要结局为功能独立（mRS 评分 0-2）、良好结局（mRS 评分 0-1）、残疾程度（所有 7 个 mRS 评分的分布）、死亡率和 1 年时的健康相关生活质量。

结果

在有 1 年随访数据的 330 例患者中，227 例（68.8%）为男性，平均（SD）年龄为 67.0（10.7）岁。在血栓切除术组中，1 年时 mRS 评分为 0 至 3 的患者为 222 例中的 99 例（44.6%），对照组为 108 例中的 21 例（19.4%）（调整后率比，2.23；95%CI，1.51-3.29）。与 90 天相比，1 年时血栓切除术组（222 例中的 101 例[45.5%]）和对照组（108 例中的 69 例[63.9%]）的死亡率更高。与 90 天相比，1 年时血栓切除术组的良好结局（mRS 评分 0-1）（222 例中的 62 例[27.9%]）增加，但对照组没有（108 例中的 9 例[8.3%]），这导致治疗效果更加显著。