-
Randomized Controlled Trial
Trial of Endovascular Thrombectomy for Large Ischemic Strokes.
- Amrou Sarraj, Ameer E Hassan, Michael G Abraham, Santiago Ortega-Gutierrez, Scott E Kasner, M Shazam Hussain, Michael Chen, Spiros Blackburn, Clark W Sitton, Leonid Churilov, Sophia Sundararajan, Yin C Hu, Nabeel A Herial, Pascal Jabbour, Daniel Gibson, Adam N Wallace, Juan F Arenillas, Jenny P Tsai, Ronald F Budzik, William J Hicks, Osman Kozak, Bernard Yan, Dennis J Cordato, Nathan W Manning, Mark W Parsons, Ricardo A Hanel, Amin N Aghaebrahim, Teddy Y Wu, Pere Cardona-Portela, Natalia Pérez de la Ossa, Joanna D Schaafsma, Jordi Blasco, Navdeep Sangha, Steven Warach, Chirag D Gandhi, Timothy J Kleinig, Daniel Sahlein, Lucas Elijovich, Wondwossen Tekle, Edgar A Samaniego, Laith Maali, M Ammar Abdulrazzak, Marios N Psychogios, Ashfaq Shuaib, Deep K Pujara, Faris Shaker, Hannah Johns, Gagan Sharma, Vignan Yogendrakumar, Felix C Ng, Mohammad H Rahbar, Chunyan Cai, Philip Lavori, Scott Hamilton, Thanh Nguyen, Johanna T Fifi, Stephen Davis, Lawrence Wechsler, Vitor M Pereira, Maarten G Lansberg, Michael D Hill, James C Grotta, Marc Ribo, Bruce C Campbell, Gregory W Albers, and SELECT2 Investigators.
- 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.).
- N. Engl. J. Med. 2023 Apr 6; 388 (14): 125912711259-1271.
BackgroundTrials of the efficacy and safety of endovascular thrombectomy in patients with large ischemic strokes have been carried out in limited populations.MethodsWe 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.ResultsThe 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.ConclusionsAmong 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.).Copyright © 2023 Massachusetts Medical Society.
Notes
Knowledge, pearl, summary or comment to share?You can also include formatting, links, images and footnotes in your notes
- Simple formatting can be added to notes, such as
*italics*
,_underline_
or**bold**
. - Superscript can be denoted by
<sup>text</sup>
and subscript<sub>text</sub>
. - Numbered or bulleted lists can be created using either numbered lines
1. 2. 3.
, hyphens-
or asterisks*
. - Links can be included with:
[my link to pubmed](http://pubmed.com)
- Images can be included with:
![alt text](https://bestmedicaljournal.com/study_graph.jpg "Image Title Text")
- For footnotes use
[^1](This is a footnote.)
inline. - Or use an inline reference
[^1]
to refer to a longer footnote elseweher in the document[^1]: This is a long footnote.
.