Trial of Endovascular Thrombectomy for Large Ischemic Strokes.

Humans Brain Ischemia / diagnostic imaging Endovascular Procedures / adverse effects Fibrinolytic Agents / adverse effects Ischemic Stroke / diagnostic imaging Prospective Studies Stroke / diagnostic imaging Thrombectomy / adverse effects Treatment Outcome Infarction, Middle Cerebral Artery / complications Carotid Artery Diseases / complications Recovery of Function Cerebral Hemorrhage / chemically induced

Journal

The New England journal of medicine

ISSN: 1533-4406

Titre abrégé: N Engl J Med

Pays: United States

ID NLM: 0255562

Informations de publication

Date de publication:
06 Apr 2023

Historique:

medline: 7 4 2023

pubmed: 11 2 2023

entrez: 10 2 2023

Statut: ppublish

Résumé

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.).

Sections du résumé

BACKGROUND BACKGROUND

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

METHODS 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 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 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.).

Identifiants

DOI: 10.1056/NEJMoa2214403 PMID: 36762865

pubmed: 36762865

doi: 10.1056/NEJMoa2214403

doi:

Substances chimiques

Fibrinolytic Agents 0

Banques de données

ClinicalTrials.gov

['NCT03876457']

Types de publication

Randomized Controlled Trial Journal Article

Langues

eng

Sous-ensembles de citation

Pagination

1259-1271

Subventions

Organisme : Stryker

ID : NA

Investigateurs

Amrou Sarraj (A)

Sophia Sundararajan (S)

Yin Hu (Y)

Cathy Sila (C)

Anthony Furlan (A)

Amanda Opaskar (A)

Nicholas Bambakidis (N)

Abhishek Ray (A)

Jeffrey Sunshine (J)

Sepideh Amin-Hanjani (S)

Michael DeGeorgia (M)

Wei Xiong (W)

Rose Duncan (R)

Ali Fadhil (A)

Ari M Blitz (AM)

Jennifer E Sommer (JE)

John Hansen (J)

Mohit Patel (M)

Arunit Chugh (A)

Faisal Al-Shaibi (F)

Majed Alomar (M)

Soheil El-Azzouni (S)

Rami B Moussa (RB)

Dasul Jin (D)

Katrina M Nayak (KM)

Yiyi Zhang (Y)

Nikhil S Modak (NS)

Muruj M Jumah (MM)

Deng-Yuan Dean Liou (DD)

Abdullah Alamoudi (A)

Alex Y Chen (AY)

Sean Michael Duke (SM)

Yazid Saidi (Y)

Abdalmalik Khalid Bin Khunayfir (AKB)

Rami Ibrahim (R)

Alexander L Lewis (AL)

Hemani Ticku (H)

Anthony Peter Zampino (AP)

Spiros Blackburn (S)

James C Grotta (JC)

Clark Sitton (C)

Mohammad H Rahbar (MH)

Mark Dannenbaum (M)

Roy Riascos (R)

Gary Spiegel (G)

Andrew Barreto (A)

Anjail Sharieff (A)

Joseph Cochran (J)

Arthur L Day (AL)

Nicole Gonzales (N)

Sujan Reddy (S)

Lauren Fournier (L)

Erica M Jones (EM)

Pamela Zelini (P)

Haris Kamal (H)

Felix Guerra Castanon (F)

Naveed Asim (N)

Michael Abraham (M)

Laith Maali (L)

Koji Ebersole (K)

Jorge Kawano (J)

Colleen Lechtenberg (C)

Sabreena Slavin (S)

Latih Maali (L)

Ernest Madarang (E)

Aparna Pendurthi (A)

Abid Qureshi (A)

Alan Reeves (A)

Lee Rosterman (L)

Yunxia Wang (Y)

Tiffany Thu Barkley (TT)

Husitha Vanguru (H)

Jeremy Paterson (J)

Ricardo Hanel (R)

Amin N Aghaebrahim (AN)

Eric Sauvageau (E)

M Shazam Hussain (MS)

Mohammad A Abdulrazzak (MA)

Ken Uchino (K)

Irene Katzan (I)

Mei Lu (M)

Gabor Toth (G)

Andrew Russman (A)

Dolora Wisco (D)

Jayashree Sundararajan (J)

Andrew Buletko (A)

Mark Bain (M)

Nina Moore (N)

Alex Witek (A)

Marek Cierny (M)

Ashutosh Mahapatra (A)

Ghulum Kharal (G)

Denice Limbert (D)

Tina Resser (T)

Michael Chen (M)

Stephan Munich (S)

Richard Crowley (R)

Elizabeth McLaughlin (E)

Sarah Song (S)

Steven Warach (S)

Truman J Milling (TJ)

Jefferson Miley (J)

Kent Ellington (K)

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Commentaires et corrections

Type : CommentIn

Informations de copyright

Auteurs

Amrou Sarraj (A)

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.).

Classifications MeSH

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questionsmedicales.fr › Maladies cardiovasculaires › Maladies vasculaires › Angiopathies intracrâniennes › Encéphalopathie ischémique › Trial of Endovascular Thrombectomy for Large...

questionsmedicales.fr › Procédures de chirurgie opératoire › Interventions chirurgicales mini-invasives › Procédures endovasculaires › Trial of Endovascular Thrombectomy for Large...

questionsmedicales.fr › Actions chimiques et utilisations › Actions pharmacologiques › Utilisations thérapeutiques › Agents hématologiques › Fibrinolytiques › Trial of Endovascular Thrombectomy for Large...

questionsmedicales.fr › Maladies cardiovasculaires › Maladies vasculaires › Angiopathies intracrâniennes › Accident vasculaire cérébral › Accident vasculaire cérébral ischémique › Trial of Endovascular Thrombectomy for Large...

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questionsmedicales.fr › Maladies cardiovasculaires › Maladies vasculaires › Angiopathies intracrâniennes › Accident vasculaire cérébral › Trial of Endovascular Thrombectomy for Large...

questionsmedicales.fr › Procédures de chirurgie opératoire › Procédures de chirurgie cardiovasculaire › Procédures de chirurgie vasculaire › Thrombectomie › Trial of Endovascular Thrombectomy for Large...

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