Hospital Universitario La Paz, Madrid, Spain.
Department of Neuroradiology, Universitätsklinikum Schleswig-Holstein, Lübeck, Germany.
Interv Neuroradiol. 2020 Apr;26(2):178-186. doi: 10.1177/1591019919894800. Epub 2019 Dec 17.
BACKGROUND/PURPOSE: The benefit of endovascular thrombectomy in acute ischemic stroke (AIS) therapy of proximal large vessel occlusions (LVO) is established. However, there are few prospective studies evaluating the use of a direct aspiration first pass technique in distal vessel occlusions. This post hoc analysis of the PROMISE study examines the safety and effectiveness of the Penumbra System with the ACE68 and ACE64 Reperfusion Catheters for aspiration thrombectomy in the M1 and M2 segments of the middle cerebral artery.
PROMISE is a prospective, multicenter study that enrolled 204 patients with anterior circulation LVO AIS-treated frontline with ACE68/ACE64 catheters. We compared clinical and angiographic outcomes, complications, and mortality in patients with M1 and M2 occlusions. The association of M1 and M2 location and functional independence or mTICI 2b-3 reperfusion was described in univariable and multivariable analyses.
One hundred sixty-one patients (124 M1 and 37 M2 locations) met the study criteria. Post procedure mTICI 2b-3 reperfusion (93% vs. 92%, = 1.00), functional independence (57% vs. 70%, = 0.18), symptomatic intracranial hemorrhage (1.6% vs. 2.7%, = 0.55), device- or procedure-related serious adverse events at 30 days (4.0% vs. 8.1%, = 0.39), and mortality at 90 days (6.6% vs. 2.7%, = 0.69) were comparable between M1 and M2 occlusions. In multivariable analysis, lower age, lower baseline NIHSS, and shorter time from onset to admission were independent predictors of functional independence.
For frontline aspiration thrombectomy of stroke, use of large-bore ACE68/ACE64 catheters for treatment of M2 occlusions appeared as safe and effective as for M1 occlusions.
背景/目的:血管内血栓切除术治疗急性缺血性脑卒中(AIS)伴近端大血管闭塞(LVO)的益处已得到证实。然而,很少有前瞻性研究评估直接抽吸首过技术在远端血管闭塞中的应用。本研究对 PROMISE 研究进行了事后分析,评估了 Penumbra 系统联合 ACE68 和 ACE64 再通导管抽吸血栓切除术在大脑中动脉 M1 和 M2 段的安全性和有效性。
PROMISE 是一项前瞻性、多中心研究,共纳入 204 例前循环 LVO AIS 患者,一线采用 ACE68/ACE64 导管治疗。我们比较了 M1 和 M2 闭塞患者的临床和血管造影结局、并发症和死亡率。采用单变量和多变量分析描述了 M1 和 M2 部位与功能独立性或 mTICI 2b-3 再通的关系。
符合研究标准的患者共 161 例(124 例 M1 闭塞,37 例 M2 闭塞)。术后 mTICI 2b-3 再通率(93% vs. 92%, = 1.00)、功能独立性(57% vs. 70%, = 0.18)、症状性颅内出血(1.6% vs. 2.7%, = 0.55)、30 天内与器械或操作相关的严重不良事件(4.0% vs. 8.1%, = 0.39)和 90 天死亡率(6.6% vs. 2.7%, = 0.69)在 M1 和 M2 闭塞之间无显著差异。多变量分析显示,年龄较小、基线 NIHSS 评分较低、发病至入院时间较短是功能独立性的独立预测因素。
对于 AIS 患者的一线抽吸血栓切除术,使用大口径 ACE68/ACE64 导管治疗 M2 闭塞与 M1 闭塞同样安全有效。