Journal article
Trial of Endovascular Thrombectomy for Large Ischemic Strokes
The New England journal of medicine, Vol.388(14), pp.1259-1271
04/06/2023
DOI: 10.1056/NEJMoa2214403
PMID: 36762865
Abstract
Trials of the efficacy and safety of endovascular thrombectomy in patients with large ischemic strokes have been carried out in limited populations.
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.
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.
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.).
Details
- Title: Subtitle
- Trial of Endovascular Thrombectomy for Large Ischemic Strokes
- Creators
- Amrou SarrajSantiago Ortega-GutierrezAmeer E HassanAdam N WallaceMichael G AbrahamEdgar A SamaniegoScott E KasnerM Shazam HussainMichael ChenSpiros BlackburnClark W SittonLeonid ChurilovSophia SundararajanYin C HuNabeel A HerialPascal JabbourDaniel GibsonJuan F ArenillasJenny P TsaiRonald F BudzikWilliam J HicksOsman KozakBernard YanDennis J CordatoNathan W ManningMark W ParsonsRicardo A HanelAmin N AghaebrahimTeddy Y WuPere Cardona-PortelaNatalia Pérez de la OssaJoanna D SchaafsmaJordi BlascoNavdeep SanghaSteven WarachChirag D GandhiTimothy J KleinigDaniel SahleinLucas ElijovichWondwossen TekleLaith MaaliM Ammar AbdulrazzakMarios N PsychogiosAshfaq ShuaibDeep K PujaraFaris ShakerHannah JohnsGagan SharmaVignan YogendrakumarFelix C NgMohammad H RahbarChunyan CaiPhilip LavoriScott HamiltonThanh NguyenJohanna T FifiStephen DavisLawrence WechslerVitor M PereiraMaarten G LansbergMichael D HillJames C GrottaMarc RiboBruce C CampbellGregory W AlbersSELECT2 Investigators
- Resource Type
- Journal article
- Publication Details
- The New England journal of medicine, Vol.388(14), pp.1259-1271
- DOI
- 10.1056/NEJMoa2214403
- PMID
- 36762865
- ISSN
- 0028-4793
- eISSN
- 1533-4406
- Grant note
- DOI: 10.13039/100008894, name: Stryker, award: NA
- Language
- English
- Electronic publication date
- 02/10/2023
- Date published
- 04/06/2023
- Academic Unit
- Neurology; Radiology; Iowa Neuroscience Institute; Neurosurgery
- Record Identifier
- 9984366154802771
Metrics
14 Record Views