Neurosurgery, The Mount Sinai Hospital, New York, New York, USA
Neurosurgery and Radiology and Canon Stroke and Vascular Research Center, University at Buffalo Jacobs School of Medicine and Biomedical Sciences, Buffalo, New York, USA.
J Neurointerv Surg. 2022 Feb;14(2):126-132. doi: 10.1136/neurintsurg-2021-017315. Epub 2021 Feb 25.
The PerfusiOn imaging Selection of Ischemic sTroke patIents for endoVascular thErapy (POSITIVE) trial was designed to evaluate functional outcome in patients with emergent large vessel occlusion (ELVO) presenting within 0-12 hours with pre-specified bifurcated arms of early and late window presentation, who were selected for endovascular thrombectomy with non-vendor specific commercially available perfusion imaging software. Recent trials demonstrating the benefit of thrombectomy up to 16-24 hours following ELVO removed equipoise to randomize late window ELVO patients and therefore the trial was halted.
Up to 200 patients were to be enrolled in this FDA-cleared, prospective, randomized, multicenter international trial to compare thrombectomy and best medical management in patients with ELVO ineligible for or refractory to treatment with IV tissue plasminogen activator (IV-tPA) selected with perfusion imaging and presenting within 0-12 hours of last seen normal. The primary outcome was 90-day clinical outcome as measured by the raw modified Rankin Scale (mRS) with scores 5 and 6 collapsed (mRS shift analysis).
The POSITIVE trial suspended enrollment with the release of results from the DAWN trial and was stopped after the release of the DEFUSE 3 trial results. Thirty-three patients were enrolled (21 for medical management and 12 for thrombectomy). Twelve of the 33 patients were enrolled in the 6-12 hour cohort. Despite the early cessation, the primary outcome demonstrated statistically significant superior clinical outcomes for patients treated with thrombectomy (P=0.0060). The overall proportion of patients achieving an mRS score of 0-2 was 75% in the thrombectomy cohort and 43% in the medical management cohort (OR 4.00, 95% CI 0.84 to 19.2).
POSITIVE supports the already established practice of delayed thrombectomy for appropriately selected patients presenting within 0-12 hours selected by perfusion imaging from any vendor. The results of the POSITIVE trial are consistent with other thrombectomy trials. The statistically significant effect on functional improvement, despite the small number of patients, reinforces the robust benefits of thrombectomy.
NCT01852201.
灌注成像选择缺血性卒中患者进行血管内治疗（POSITIVE）试验旨在评估在出现大血管闭塞（ELVO）后 0-12 小时内出现的紧急情况患者的功能结局，这些患者通过非供应商专用的商业灌注成像软件选择进行血管内血栓切除术。最近的试验证明，在 ELVO 后 16-24 小时内进行血栓切除术的益处，从而消除了对随机分配晚期窗口 ELVO 患者的平衡，并因此停止了试验。
该试验为美国食品和药物管理局批准的前瞻性、随机、多中心国际试验，共纳入 200 名患者，对不符合或对静脉组织型纤溶酶原激活剂（IV-tPA）治疗无反应的 ELVO 患者进行筛选，并通过灌注成像选择进行血管内血栓切除术，这些患者在最后一次正常观察后 0-12 小时内出现 ELVO。主要结局是 90 天临床结局，通过原始改良 Rankin 量表（mRS）进行测量，评分 5 和 6 合并（mRS 移位分析）。
POSITIVE 试验随着 DAWN 试验结果的发布而暂停入组，并在 DEFUSE 3 试验结果发布后停止。共纳入 33 名患者（21 名接受药物治疗，12 名接受血栓切除术）。在 33 名患者中，有 12 名患者入组 6-12 小时组。尽管早期停止试验，但主要结局显示接受血栓切除术治疗的患者临床结局显著改善（P=0.0060）。在血栓切除术组中，有 75%的患者达到 mRS 评分 0-2，而在药物治疗组中，有 43%的患者达到 mRS 评分 0-2（OR 4.00，95%CI 0.84 至 19.2）。
POSITIVE 支持已经建立的延迟性血栓切除术实践，对于通过任何供应商的灌注成像选择的在 0-12 小时内出现的适当患者进行治疗。POSITIVE 试验的结果与其他血栓切除术试验一致。尽管患者数量较少，但功能改善的统计学显著效果，强化了血栓切除术的强大益处。
NCT01852201。
