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机械取栓与非 DEFUSE3 非 DAWN 患者晚期时间窗内最佳药物治疗的比较:一项多中心队列研究。

Mechanical Thrombectomy Versus Best Medical Treatment in the Late Time Window in Non-DEFUSE-Non-DAWN Patients: A Multicenter Cohort Study.

机构信息

Department of Neurology, University Hospital Basel and University of Basel, Switzerland (T.D.D., L.F.K., S.R., A.Z., A.A.P., C.T., S.T., B.W., V.L.A., I.P., H.G., S.T.E., P.A.L., M.K., N.P., L.H.B., U.F., G.M.D.M.).

Department of Neuroradiology, University Hospital Basel, Switzerland (P.B.S., A.N., M.P.).

出版信息

Stroke. 2023 Mar;54(3):722-730. doi: 10.1161/STROKEAHA.122.039793. Epub 2023 Jan 31.

Abstract

BACKGROUND

We assessed the efficacy and safety of mechanical thrombectomy (MT) in adult stroke patients with anterior circulation large vessel occlusion presenting in the late time window not fulfilling the DEFUSE-3 (Thrombectomy for Stroke at 6 to 16 Hours With Selection by Perfusion Imaging trial) and DAWN (Thrombectomy 6 to 24 Hours After Stroke With a Mismatch Between Deficit and Infarct trial) inclusion criteria.

METHODS

Cohort study of adults with anterior circulation large vessel occlusion admitted between 6 and 24 hours after last-seen-well at 5 participating Swiss stroke centers between 2014 and 2021. Mismatch was assessed by computer tomography or magnetic resonance imaging perfusion with automated software (RAPID or OLEA). We excluded patients meeting DEFUSE-3 and DAWN inclusion criteria and compared those who underwent MT with those receiving best medical treatment alone by inverse probability of treatment weighting using the propensity score. The primary efficacy end point was a favorable functional outcome at 90 days, defined as a modified Rankin Scale score shift toward lower categories. The primary safety end point was symptomatic intracranial hemorrhage within 7 days of stroke onset; the secondary was all-cause mortality within 90 days.

RESULTS

Among 278 patients with anterior circulation large vessel occlusion presenting in the late time window, 190 (68%) did not meet the DEFUSE-3 and DAWN inclusion criteria and thus were included in the analyses. Of those, 102 (54%) received MT. In the inverse probability of treatment weighting analysis, patients in the MT group had higher odds of favorable outcomes compared with the best medical treatment alone group (modified Rankin Scale shift: acOR, 1.46 [1.02-2.10]; =0.04) and lower odds of all-cause mortality within 90 days (aOR, 0.59 [0.37-0.93]; =0.02). There were no significant differences in symptomatic intracranial hemorrhage (MT versus best medical treatment alone: 5% versus 2%, =0.63).

CONCLUSIONS

Two out of 3 patients with anterior circulation large vessel occlusion presenting in the late time window did not meet the DEFUSE-3 and DAWN inclusion criteria. In these patients, MT was associated with higher odds of favorable functional outcomes without increased rates of symptomatic intracranial hemorrhage. These findings support the enrollment of patients into ongoing randomized trials on MT in the late window with more permissive inclusion criteria.

摘要

背景

我们评估了机械取栓术(MT)在满足 DEFUSE-3(血栓切除术治疗 6 至 16 小时的卒中伴灌注成像试验)和 DAWN(卒中后 6 至 24 小时的血栓切除术伴不匹配试验)纳入标准的前循环大血管闭塞成人患者中晚期时间窗内的疗效和安全性。

方法

这是一项在 2014 年至 2021 年间,瑞士 5 家卒中中心连续纳入的前循环大血管闭塞、发病后 6 至 24 小时、不符合 DEFUSE-3 和 DAWN 纳入标准的成人患者的队列研究。通过计算机断层扫描或磁共振成像灌注,使用自动软件(RAPID 或 OLEA)评估不匹配情况。我们排除了符合 DEFUSE-3 和 DAWN 纳入标准的患者,并通过倾向评分的逆概率处理加权法,比较接受 MT 治疗和单独接受最佳药物治疗的患者。主要疗效终点是 90 天时的良好功能结局,定义为改良 Rankin 量表评分向较低类别转变。主要安全性终点是卒中发病后 7 天内的症状性颅内出血;次要终点是 90 天内的全因死亡率。

结果

在 278 例前循环大血管闭塞的晚期患者中,190 例(68%)不符合 DEFUSE-3 和 DAWN 纳入标准,因此纳入分析。其中,102 例(54%)接受了 MT。在逆概率处理加权分析中,与单独接受最佳药物治疗的患者相比,MT 组患者有更高的良好结局几率(改良 Rankin 量表评分变化:优势比,1.46 [1.02-2.10];=0.04)和更低的 90 天内全因死亡率几率(优势比,0.59 [0.37-0.93];=0.02)。两组患者的症状性颅内出血发生率无显著差异(MT 组与单独最佳药物治疗组:5%比 2%;=0.63)。

结论

在晚期时间窗内,3 例前循环大血管闭塞患者中,有 2 例不符合 DEFUSE-3 和 DAWN 纳入标准。在这些患者中,MT 与更高的良好功能结局几率相关,而症状性颅内出血发生率没有增加。这些发现支持将更多宽松纳入标准的晚期时间窗 MT 患者纳入正在进行的随机试验。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ca39/10561685/94fdd8d68d6c/str-54-722-g001.jpg

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