Bailout Intracranial Angioplasty or Stenting After Thrombectomy for Acute Large Vessel Occlusion: 1-Year Outcomes of ANGEL-REBOOT.

This study compared BAOS with standard therapy in patients with large vessel occlusion with unsuccessful recanalization (expanded Thrombolysis In Cerebral Infarction score 0-2a) or >70% residual stenosis after thrombectomy.

本研究比较了在大血管闭塞患者中，经导管溶栓后未能成功再通（扩展的脑梗死溶栓治疗评分0-2a）或溶栓后残余狭窄>70%的患者中，BAOS与标准治疗的效果。

Methods

ANGEL-REBOOT (Randomized Study of Bailout Intracranial Angioplasty Following Thrombectomy for Acute Large Vessel Occlusion) was a multicenter, open-label, blinded-end point, randomized trial conducted across 36 Chinese hospitals.

ANGEL-REBOOT（针对急性大血管闭塞后的补救性颅内球囊扩张术后的支架取栓的随机研究）是一项在中国36家医院进行的多中心、开放标签、终点盲法的随机试验。

Patients ≥18 years of age with anterior or posterior circulation large vessel occlusion within 24 hours of stroke onset were enrolled.

纳入标准为年龄≥18岁的患者，且在中风发作后24小时内出现前循环或后循环大血管闭塞。

After identification of thrombectomy failure or high-grade residual stenosis, patients were randomly assigned to the BAOS group (intervention) or the standard therapy group (control), in which thrombectomy was continued or terminated.

在确定血栓切除失败或高分级残余狭窄后，患者被随机分配到BAOS组（干预组）或标准治疗组（对照组），在该组中，血栓切除继续或终止。

The use of tirofiban was permitted in both groups during and after the procedure.

在手术过程中及之后，两组均允许使用替罗非班。

In the intention-to-treatpopulation, the primary outcome was analyzed using an assumption-free ordinal analysis (Wilcoxon-Mann-Whitney test) to compare the modified Rankin Scale scores (ordinal variable ranging from 0 to 6) between groups at 1-year follow-up, from which the generalized odds ratio was derived.

在意向治疗人群中，主要结果通过无假设的序数分析（Wilcoxon-Mann-Whitney检验）进行比较，以分析1年随访时两组之间的改良Rankin量表评分（序数变量，范围从0到6），从中得出广义优势比。

Secondary outcomes included stroke recurrence in the treated artery and all-cause mortality within 1 year, analyzed using Cox proportional hazards models.

次要结果包括治疗动脉的中风复发和1年内的全因死亡率，使用Cox比例风险模型进行分析。

Results

A total of 348 patients were randomly assigned (176 to the BAOS group and 172 to the standard therapy group) and followed for 90 days, from December 19, 2021, to June 2, 2023.

共有348名患者被随机分配（BAOS组176人，标准治疗组172人），并从2021年12月19日至2023年6月2日进行了90天的随访。

Of these, 326 patients (166 in the BAOS group and 160 in the standard therapy group) completed the 1-year follow-up.

在这些患者中，326名患者（BAOS组166人，标准治疗组160人）完成了1年的随访。

Compared with standard therapy, BAOS significantly improved the 1-year modified Rankin Scale score distribution (generalized odds ratio, 1.34 [95% CI, 1.05-1.73]; P=0.02).

与标准治疗相比，BAOS显著改善了1年改良Rankin量表评分分布（广义比值比，1.34 [95% 置信区间，1.05-1.73]；P=0.02）。

Fewer stroke recurrences in the treated artery occurred in the BAOS group than in the standard therapy group (7 of 166 [4%] versus 21 of 160 [13%]; hazard ratio, 0.30 [95% CI, 0.13-0.71]; P=0.006).

在BAOS组中，治疗动脉的中风复发次数少于标准治疗组（166例中有7例[4%]对比160例中有21例[13%]；风险比，0.30 [95% 置信区间，0.13-0.71]；P=0.006）。

One-year mortality rates were similar between groups (25 of 166 [15%] versus 27 of 160 [17%]; hazard ratio, 0.87 [95% CI, 0.50-1.50]).

两组的一年死亡率相似（166人中有25人[15%]对比160人中有27人[17%]；风险比为0.87[95%置信区间，0.50-1.50]）。

Conclusions

Among Chinese patients with large vessel occlusion with unsuccessful recanalization or high-grade residual stenosis after thrombectomy, BAOS was associated with reduced disability and stroke recurrence after 1 year compared with standard therapy.

在中国患有大血管闭塞且血栓切除后未能再通或存在高度残余狭窄的患者中，与标准治疗相比，BAOS与一年后残疾程度降低和中风复发减少相关。

registration

URL: https://www.clinicaltrials.gov; Unique identifier: NCT05122286.

网址: https://www.clinicaltrials.gov; 唯一标识符: NCT05122286.