Endovascular thrombectomy plus medical care versus medical care alone for large ischaemic stroke: 1-year outcomes of the SELECT2 trial

被引:23
|
作者
Sarraj, Amrou [1 ,3 ]
Abraham, Michael G. [5 ]
Hassan, Ameer E. [6 ]
Blackburn, Spiros [7 ]
Kasner, Scott E. [10 ]
Ortega-Gutierrez, Santiago [11 ]
Hussain, Muhammad Shazam [12 ]
Chen, Michael [13 ]
Johns, Hannah [14 ]
Churilov, Leonid [14 ]
Pujara, Deep K. [1 ,3 ]
Shaker, Faris [7 ]
Maali, Laith [5 ]
Portela, Pere Cardona [15 ]
Herial, Nabeel A. [16 ]
Gibson, Daniel [17 ]
Kozak, Osman [18 ]
Arenillas, Juan F. [19 ]
Yan, Bernard [14 ,20 ]
de la Ossa, Natalia Perez [21 ]
Sundararajan, Sophia [1 ,3 ]
Hu, Yin C. [2 ,4 ]
Cordato, Dennis J. [22 ,27 ]
Manning, Nathan W. [23 ]
Hanel, Ricardo A. [24 ]
Aghaebrahim, Amin N. [24 ]
Budzik, Ronald F. [25 ]
Hicks, William J. [26 ]
Blasco, Jordi [27 ]
Wu, Teddy Y. [28 ]
Tsai, Jenny P. [12 ]
Schaafsma, Joanna D. [29 ]
Gandhi, Chirag D. [30 ]
Al-Mufti, Fawaz [30 ]
Sangha, Navdeep [31 ]
Warach, Steven [32 ]
Kleinig, Timothy J. [33 ]
Yogendrakumar, Vignan [20 ]
Ng, Felix [20 ]
Samaniego, Edgar A. [11 ]
Abdulrazzak, Mohammad A. [12 ]
Parsons, Mark W. [22 ]
Rahbar, Mohammad H. [8 ]
Nguyen, Thanh N. [34 ]
Fifi, Johanna T. [35 ]
Pereira, Vitor Mendes [36 ]
Lansberg, Maarten G. [37 ]
Albers, Greg W. [37 ]
Furlan, Anthony J. [1 ,3 ]
Jabbour, Pascal [16 ]
机构
[1] Univ Hosp Cleveland Med Ctr, Dept Neurol, Cleveland, OH 44106 USA
[2] Univ Hosp Cleveland Med Ctr, Dept Neurosurg, Cleveland, OH USA
[3] Case Western Reserve Univ, Dept Neurol, Cleveland, OH USA
[4] Case Western Reserve Univ, Dept Neurosurg, Cleveland, OH USA
[5] Univ Kansas, Med Ctr, Dept Neurol, Kansas City, KS USA
[6] Valley Baptist Med Ctr, Dept Neurosci, Harlingen, TX USA
[7] McGovern Med Sch UTHealth, Dept Neurosurg, Houston, TX USA
[8] UTHlth, Dept Internal Med, McGovern Med Sch, Houston, TX USA
[9] UTHlth, Dept Intervent & Diagnost Imaging, McGovern Med Sch, Houston, TX USA
[10] Univ Penn, Dept Neurol, Philadelphia, PA USA
[11] Univ Iowa Hosp & Clin, Dept Neurosurg & Radiol, Iowa City, IA USA
[12] Cleveland Clin, Cerebrovasc Ctr, Cleveland, OH USA
[13] Rush Univ, Med Ctr, Dept Neurosurg, Chicago, IL USA
[14] Univ Melbourne, Dept Med & Neurol, Parkville, Vic, Australia
[15] Hosp Univ Bellvitge, Dept Neurol, Bellvitge, Spain
[16] Thomas Jefferson Univ Hosp, Dept Neurosurg, Philadelphia, PA USA
[17] Ascension Wisconsin, Dept Neurosurg, Indianapolis, IN USA
[18] Abington Jefferson Hlth, Dept Neurosurg, Abington, PA USA
[19] Univ Valladolid, Hosp Clin Univ Valladolid, Dept Internal Med, Valladolid, Spain
[20] Royal Melbourne Hosp, Melbourne Brain Ctr, Dept Internal Med & Neurol, Parkville, Vic, Australia
[21] Hosp Univ Germans Trias i Pujol, Dept Neurol, Barcelona, Spain
[22] Liverpool Hosp, Dept Neurol, Liverpool, NSW, Australia
[23] Ingham Inst, Dept Neurosurg, Liverpool, NSW, Australia
[24] Baptist Med Ctr Jacksonville, Dept Neurosurg, Jacksonville, FL USA
[25] OhioHlth Riverside Methodist Hosp, Dept Neurointervent Radiol, Columbus, OH USA
[26] OhioHlth Riverside Methodist Hosp, Dept Neurol, Columbus, OH USA
[27] Hosp Clin Barcelona, Dept Intervent Radiol, Barcelona, Spain
[28] Christchurch Hosp, Dept Neurol, Christchurch, New Zealand
[29] Toronto Western Hosp, Dept Internal Med, Toronto, ON, Canada
[30] NY Med Coll, Westchester Med Ctr, Dept Neurosurg, Valhalla, NY USA
[31] Kaiser Permanente Southern Calif, Dept Neurol, Los Angeles, CA USA
[32] Univ Texas Austin Ascension Texas, Dell Med Sch, Dept Neurol, Austin, TX USA
[33] Royal Adelaide Hosp, Dept Neurol, Adelaide, SA, Australia
[34] Boston Med Ctr, Dept Neurol, Boston, MA USA
[35] Icahn Sch Med Mt Sinai, Dept Neurol, New York, NY USA
[36] St Michaels Hosp, Dept Neurol, Toronto, ON, Canada
[37] Stanford Univ, Dept Neurol, Stanford, CA USA
[38] Univ Pittsburgh, Med Ctr, Dept Neurol, Pittsburgh, PA USA
[39] Univ Calgary, Dept Clin Neurosci, Calgary, AB, Canada
[40] Mem Hermann Hosp, Mobile Stroke Unit, Houston, TX USA
[41] Hosp Valle De Hebron, Dept Neurol, Barcelona, Spain
[42] Florey Inst Neurosci & Mental Hlth, Dept Med & Neurol, Parkville, Vic, Australia
来源
LANCET | 2024年 / 403卷 / 10428期
关键词
HUMAN BRAIN;
D O I
10.1016/S0140-6736(24)00050-3
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
Background Multiple randomised trials have shown efficacy and safety of endovascular thrombectomy in patients with large ischaemic stroke. The aim of this study was to evaluate long-term (ie, at 1 year) evidence of benefit of thrombectomy for these patients. Methods SELECT2 was a phase 3, open-label, international, randomised controlled trial with blinded endpoint assessment, conducted at 31 hospitals in the USA, Canada, Spain, Switzerland, Australia, and New Zealand. Patients aged 18-85 years with ischaemic stroke due to proximal occlusion of the internal carotid artery or of the first segment of the middle cerebral artery, showing large ischaemic core on non-contrast CT (Alberta Stroke Program Early Computed Tomographic Score of 3-5 [range 0-10, with lower values indicating larger infarctions]) or measuring 50 mL or more on CT perfusion and MRI, were randomly assigned, within 24 h of ischaemic stroke onset, to thrombectomy plus medical care or to medical care alone. The primary outcome for this analysis was the ordinal modified Rankin Scale (range 0-6, with higher scores indicating greater disability) at 1-year follow-up in an intention-to-treat population. The trial is registered at ClinicalTrials.gov (NCT03876457) and is completed. Findings The trial was terminated early for efficacy at the 90-day follow-up after 352 patients had been randomly assigned (178 to thrombectomy and 174 to medical care only) between Oct 11, 2019, and Sept 9, 2022. Thrombectomy significantly improved the 1-year modified Rankin Scale score distribution versus medical care alone (WilcoxonMann-Whitney probability of superiority 0<middle dot>59 [95% CI 0<middle dot>53-0<middle dot>64]; p=0<middle dot>0019; generalised odds ratio 1<middle dot>43 [95% CI 1<middle dot>14-1<middle dot>78]). At the 1-year follow-up, 77 (45%) of 170 patients receiving thrombectomy had died, compared with 83 (52%) of 159 patients receiving medical care only (1-year mortality relative risk 0<middle dot>89 [95% CI 0<middle dot>71-1<middle dot>11]). Interpretation In patients with ischaemic stroke due to a proximal occlusion and large core, thrombectomy plus medical care provided a significant functional outcome benefit compared with medical care alone at 1-year follow-up. Funding Stryker Neurovascular. Copyright (c) 2024 Elsevier Ltd. All rights reserved.
引用
收藏
页码:731 / 740
页数:10
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