美国克利夫兰大学医学中心Amrou Sarraj团队研究了大面积缺血性脑卒中血管内取栓治疗的疗效与安全性。2023年2月10日出版的《新英格兰医学杂志》发表了这项成果。

血管内取栓治疗严重缺血性脑卒中患者的有效性和安全性的试验已在有限人群中进行。

研究组进行了一项前瞻性、随机、开放标签、适应性的国际试验，招募因颈内动脉或大脑中动脉第一段闭塞而卒中的患者，以评估发病后24小时内的血管内取栓术。患者缺血核体积较大，定义为阿尔伯塔脑卒中计划早期计算机断层评分为3至5（范围为0至10，分数越低表明梗死更大）或计算机断层灌注或扩散加权磁共振成像中核体积至少为50毫升。患者按1:1的比例被随机分配到血管内取栓加医疗护理组或单独接受医疗护理组。主要结局为90天的改良Rankin量表评分（范围0-6，分数越高表明残疾程度越高）。功能独立性是次要结局。

试验因疗效问题提前终止；178例患者被分配到取栓组，174例被分配到医疗护理组。取栓组的改良Rankin量表评分显著优于医疗护理组，广义优势比为1.51。取栓组中20%的患者和医疗护理组中7%的患者具有功能独立性，相对风险为2.97。两组的死亡率相似。取栓组发生动脉通路并发症5例、夹层10例，脑血管穿孔7例，短暂性血管痉挛11例。取栓组有1例出现症状性颅内出血，医疗护理组有2例。

研究结果表明，对于重度缺血性中风患者，血管内取栓的功能效果优于内科治疗，但与血管并发症相关。两组脑出血发生率均较低。

附：英文原文

Title: Trial of Endovascular Thrombectomy for Large Ischemic Strokes | NEJM

Author: Amrou Sarraj, M.D.,, Ameer E. Hassan, D.O.,, Michael G. Abraham, M.D.,, Santiago Ortega-Gutierrez, M.D.,, Scott E. Kasner, M.D.,, M. Shazam Hussain, M.D.,, Michael Chen, M.D.,, Spiros Blackburn, M.D.,, Clark W. Sitton, M.D.,, Leonid Churilov, Ph.D.,, Sophia Sundararajan, M.D.,, Yin C. Hu, M.D.,, Nabeel A. Herial, M.D.,, Pascal Jabbour, M.D.,, Daniel Gibson, M.D.,, Adam N. Wallace, M.D.,, Juan F. Arenillas, M.D., Ph.D.,, Jenny P. Tsai, M.D.,, Ronald F. Budzik, M.D.,, William J. Hicks, M.D.,, Osman Kozak, M.D.,, Bernard Yan, M.B., B.S.,, Dennis J. Cordato, Ph.D.,, Nathan W. Manning, M.B., B.S.,, Mark W. Parsons, Ph.D.,, Ricardo A. Hanel, M.D.,, Amin N. Aghaebrahim, M.D.,, Teddy Y. Wu, Ph.D.,, Pere Cardona-Portela, M.D.,, Natalia Pérez de la Ossa, M.D., Ph.D.,, Joanna D. Schaafsma, M.D.,, Jordi Blasco, M.D., Ph.D.,, Navdeep Sangha, M.D.,, Steven Warach, M.D.,, Chirag D. Gandhi, M.D.,, Timothy J. Kleinig, Ph.D.,, Daniel Sahlein, M.D.,, Lucas Elijovich, M.D.,, Wondwossen Tekle, M.D.,, Edgar A. Samaniego, M.D.,, Laith Maali, M.D.,, M. Ammar Abdulrazzak, M.D.,, Marios N. Psychogios, M.D.,, Ashfaq Shuaib, M.D.,, Deep K. Pujara, M.B., B.S.,, Faris Shaker, M.B., Ch.B.,, Hannah Johns, Ph.D.,, Gagan Sharma, M.C.A.,, Vignan Yogendrakumar, M.D.,, Felix C. Ng, Ph.D.,, Mohammad H. Rahbar, Ph.D.,, Chunyan Cai, Ph.D.,, Philip Lavori, Ph.D.,, Scott Hamilton, Ph.D.,, Thanh Nguyen, M.D.,, Johanna T. Fifi, M.D.,, Stephen Davis, M.D.,, Lawrence Wechsler, M.D.,, Vitor M. Pereira, M.D.,, Maarten G. Lansberg, M.D.,, Michael D. Hill, M.D.,, James C. Grotta, M.D.,, Marc Ribo, M.D.,, Bruce C. Campbell, Ph.D.,, and Gregory W. Albers, M.D.

Issue&Volume: 2023-02-10

Abstract:

Background

Trials of the efficacy and safety of endovascular thrombectomy in patients with large ischemic strokes have been carried out in limited populations.

Methods

We performed a prospective, randomized, open-label, adaptive, international trial involving patients with stroke due to occlusion of the internal carotid artery or the first segment of the middle cerebral artery to assess endovascular thrombectomy within 24 hours after onset. Patients had a large ischemic-core volume, defined as an Alberta Stroke Program Early Computed Tomography Score of 3 to 5 (range, 0 to 10, with lower scores indicating larger infarction) or a core volume of at least 50 ml on computed tomography perfusion or diffusion-weighted magnetic resonance imaging. Patients were assigned in a 1:1 ratio to endovascular thrombectomy plus medical care or to medical care alone. The primary outcome was the modified Rankin scale score at 90 days (range, 0 to 6, with higher scores indicating greater disability). Functional independence was a secondary outcome.

Results

The trial was stopped early for efficacy; 178 patients had been assigned to the thrombectomy group and 174 to the medical-care group. The generalized odds ratio for a shift in the distribution of modified Rankin scale scores toward better outcomes in favor of thrombectomy was 1.51 (95% confidence interval [CI], 1.20 to 1.89; P<0.001). A total of 20% of the patients in the thrombectomy group and 7% in the medical-care group had functional independence (relative risk, 2.97; 95% CI, 1.60 to 5.51). Mortality was similar in the two groups. In the thrombectomy group, arterial access-site complications occurred in 5 patients, dissection in 10, cerebral-vessel perforation in 7, and transient vasospasm in 11. Symptomatic intracranial hemorrhage occurred in 1 patient in the thrombectomy group and in 2 in the medical-care group.

Conclusions

Among patients with large ischemic strokes, endovascular thrombectomy resulted in better functional outcomes than medical care but was associated with vascular complications. Cerebral hemorrhages were infrequent in both groups.

DOI: 10.1056/NEJMoa2214403

Source: https://www.nejm.org/doi/full/10.1056/NEJMoa2214403