大型缺血性卒中血管内血栓切除术试验

Trial of Endovascular Thrombectomy for Large Ischemic Strokes.

作者信息

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

机构信息

From the Departments of Neurology (A. Sarraj, S.S., D.K.P.) and Neurosurgery (Y.C.H.), University Hospitals Cleveland Medical Center-Case Western Reserve University, and the Cerebrovascular Center, Cleveland Clinic (M.S.H., J.P.T., M.A.A.), Cleveland, and the Departments of Neurointerventional Radiology (R.F.B.) and Neurology (W.J.H.), OhioHealth-Riverside Methodist Hospital, Columbus - all in Ohio; the Neuroscience Institute, Valley Baptist Medical Center, Harlingen (A.E.H., W.T.), the Departments of Neurosurgery (S.B., F.S.), Diagnostic and Interventional Imaging (C.W.S.), and Internal Medicine (M.H.R., C.C.), McGovern Medical School at UTHealth, and the Mobile Stroke Unit, Memorial Hermann Hospital (J.C.G.), Houston, and the Department of Neurology, Dell Medical School at the University of Texas at Austin, Austin (S.W.) - all in Texas; the Department of Neurology, University of Kansas Medical Center, Kansas City (M.G.A., L.M.); the Departments of Neurosurgery and Radiology (S.O.-G.) and Neurology (E.A.S.), University of Iowa Hospitals and Clinics, Iowa City; the Division of Vascular Neurology, University of Pennsylvania (S.E.K.), the Department of Neurosurgery, Thomas Jefferson University Hospital (N.A.H., P.J.), and the Department of Neurology, Hospital of the University of Pennsylvania (L.W.), Philadelphia, and Neurovascular Associates of Abington, Jefferson Health, Abington (O.K.) - all in Pennsylvania; the Department of Neurosurgery, Rush University Medical Center, Chicago (M.C.); Melbourne Medical School, University of Melbourne (L.C., H.J.), the Melbourne Brain Centre, Royal Melbourne Hospital, and the Department of Medicine, University of Melbourne (B.Y., G.S., V.Y., F.C.N., S.D., B.C.C.), and the Florey Institute of Neuroscience and Mental Health (L.C., B.C.C.), Parkville, VIC, the Departments of Neurology (D.J.C., M.W.P.) and Neurosurgery (N.W.M.), Liverpool Hospital, and the Department of Neurology, University of New South Wales (M.W.P.), Liverpool, and the Neurology Service, Royal Adelaide Hospital, Adelaide, SA (T.J.K.) - all in Australia; the Department of Neurosurgery, Ascension Columbia St. Mary's Hospital, Milwaukee (D.G., A.N.W.); the Department of Internal Medicine, Hospital Clínico Universitario de Valladolid, Valladolid (J.F.A.), the Department of Neurology, Bellvitge University Hospital (P.C.-P.), the Department of Interventional Radiology, Hospital Clínic de Barcelona (J.B.), and the Department of Neurology, Hospital Vall d'Hebrón (M.R.), Barcelona, and the Department of Neurology, Hospital Universitari Germans Trias i Pujol, Badalona (N.P.O.) - all in Spain; Neurosurgery, Corewell Health, Grand Rapids, MI (J.P.T.); Lyerly Neurosurgery, Baptist Medical Center Jacksonville, Jacksonville, FL (R.A.H., A.N.A.); the Department of Neurology, Christchurch Hospital, Christchurch, New Zealand (T.Y.W.); the Divisions of Internal Medicine and Neurology, Toronto Western Hospital (J.D.S.), and the Division of Neurology, St. Michael's Hospital (V.M.P.), Toronto, the Divisions of Internal Medicine and Neurology, University of Alberta, Edmonton (A. Shuaib), and the Department of Clinical Neurosciences, University of Calgary, Calgary, AB (M.D.H.) - all in Canada; Neurological Services, Kaiser Permanente Southern California, Los Angeles (N.S.), the Departments of Biomedical Data Science (P.L.) and Neurology (M.G.L., G.W.A.), Stanford University, Stanford, and MAPS Public Benefit Corporation, San Jose (S.H.) - all in California; the Department of Neurosurgery, Westchester Medical Center and New York Medical College, Valhalla (C.D.G.), and the Department of Neurology, Icahn School of Medicine at Mount Sinai, New York (J.T.F.) - both in New York; Interventional Neuroradiology, Goodman Campbell Brain and Spine, Carmel, IN (D.S.); Neurology, Semmes Murphey Clinic, Memphis, TN (L.E.); Neuroradiology, University Hospital Basel, Basel, Switzerland (M.N.P.); and the Neurology Department, Boston Medical Center, Boston (T.N.).

出版信息

N Engl J Med. 2023 Apr 6;388(14):1259-1271. doi: 10.1056/NEJMoa2214403. Epub 2023 Feb 10.

DOI:10.1056/NEJMoa2214403

PMID:36762865

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. (Funded by Stryker Neurovascular; SELECT2 ClinicalTrials.gov number, NCT03876457.).

摘要

背景

血管内血栓切除术治疗大面积缺血性卒中患者的疗效和安全性试验仅在有限人群中开展。

方法

我们进行了一项前瞻性、随机、开放标签、适应性国际试验，纳入因颈内动脉或大脑中动脉M1段闭塞导致卒中的患者，以评估发病24小时内的血管内血栓切除术。患者存在大面积缺血核心区域，定义为阿尔伯塔卒中项目早期计算机断层扫描评分3至5分（范围0至10分，分数越低梗死面积越大），或计算机断层扫描灌注成像或扩散加权磁共振成像显示核心区域体积至少50ml。患者按1:1比例随机分配至血管内血栓切除术联合药物治疗组或单纯药物治疗组。主要结局为90天时的改良Rankin量表评分（范围0至6分，分数越高残疾程度越高）。功能独立性为次要结局。

结果

该试验因疗效显著提前终止；178例患者被分配至血栓切除术组，174例被分配至药物治疗组。改良Rankin量表评分分布向更好结局偏移、支持血栓切除术的广义优势比为1.51（95%置信区间[CI]，1.20至1.89；P<0.001）。血栓切除术组20%的患者和药物治疗组7%的患者实现功能独立（相对风险，2.97；95%CI，1.60至5.51）。两组死亡率相似。血栓切除术组中，5例患者出现动脉穿刺部位并发症，血管夹层10例，脑血管穿孔7例，短暂性血管痉挛11例。血栓切除术组1例患者出现症状性颅内出血，药物治疗组2例。