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N Engl J Med. 2018 Jan 4;378(1):11-21. doi: 10.1056/NEJMoa1706442. Epub 2017 Nov 11.

Thrombectomy 6 to 24 Hours after Stroke with a Mismatch between Deficit and Infarct.

Collaborators (296)

Jadhav A, Al-Bayati A, Campbell D, Ducruet A, Giurgiutiu D, Gross B, Gulati D, Hammer M, Horev A, Jovin T, Kenmuir C, Limaye K, Molyneaux B, Reddy V, Rocha M, Shoirah H, Starr M, Streib C, Tadi P, Totoraitis V, Walker G, Wechsler L, Amerson L, Anderson A, Belagaje S, Bianchi N, Bouslama M, Dharia R, Gebru M, Grigoryan M, Grossberg J, Hernaiz L, Hinton J, Javalkar V, Katema A, Lahoti S, Lima A, Mahdi N, Patel V, Rangaraju S, Vardaman R, Winningham M, Davis T, Eubank G, Hicks W, Katz B, Pema P, Arquizan C, Ayrignac X, Carlander B, Charif M, Gaillard N, Gascou G, Gény C, Mourand I, Omer E, Riquelme Bareiro C, Gianatasio R, Hansen P, Janardhan V, Venizelos A, Asdaghi N, Bhatt N, Caplan J, Khandelwal P, Peterson E, Saini V, Starke R, Torres L, Wondwossen T, Abdul-Rahman D, Asi K, Bambakidis N, Blackham K, DeGeorgia M, Hu Y, Mao Y, Miller B, Murty P, Nelson J, Pace J, Ramos Estebanez C, Ray A, Singer J, Sundararajan S, Sunshine J, Talhama M, Tarr R, Xiong W, Sauvageau E, Boned S, Coscojuela P, Juega J, Maisterra O, Molina C, Muchada M, Pagola J, Rodriguez-Luna D, Rovira Á, Santamarina E, Tomasello A, Vert C, Albucher J, Bonneville F, Calvas F, Calviere L, Galitzky M, Januel A, Michelozzi C, Raposo N, Tall P, Tricoire A, Viguier A, Davies J, Siddiqui A, Snyder K, Crowley R, Moftakhar R, Kim W, Telischak N, Campbell B, Davis S, Dowling R, Meretoja A, Shah D, Wu T, Zhao H, MillanTorne M, Abraira L, Broto J, Canento T, Castaño C, Ciurans J, Crespo A, Cuadras P, Dorado L, Gomis M, Hernandez M, López-Cancio E, Martín L, Mekkaoui K, Munuera J, Palomeras E, Paré M, Planas A, Puyalto P, Pérez de la Ossa N, Remollo S, Samaniego D, Sorrentino A, Zhu N, Choe H, Herial N, Kozak O, MacKenzie L, Devlin T, Sapkota B, Calvert J, Hawk H, Quarfordt S, Sirelkhatim A, Dimartini G, Duong H, Agid R, Alrasheed D, Casaubon L, Del Campo M, Farb R, Jaigobin C, Jalini S, Krings T, Pikula A, Schaafsma J, Binning M, Hakma Z, Liebman K, Ajani Z, Chao K, Kim J, Mathena P, Noroozi J, Sangha N, Kulhari A, Mehta S, Moussavi M, Panezai S, Patel A, Acosta I, Allen E, Bellew M, Gandhi R, Manda S, Morgan W, Billinger S, Costa C, Ebersole K, Gronseth G, Husman K, LacKamp A, Lechtenberg C, Madarang E, Mittol M, Reeves A, Rippee M, Rosterman L, Rymer M, Shipley C, Wong Y, Aixut S, Aja L, Barranco R, De Miquel M, Lara B, Luttich A, Mora P, Quesada H, Given C, Newman B, Ramsey C, Satti S, Albani B, Black D, Dechant V, Eden T, Kahn E, Moftakhar P, Nomura J, Raser-Schramm J, Sivapatham T, Tai W, Zoarski G, Starkman S, Archer A, Bahr Hosseini M, Chhabra A, Duckwiler G, Frischmann L, Gonzalez N, Hinman J, Jahan R, Malhotra K, Nour M, Rao N, Sharma L, Singh P, Szeder V, Tang X, Tareshima S, Tipirneni A, Yoo B, Gupta R, Dhungana S, Hamilton R, Johnson A, Khaldi A, Koganti A, Owada K, Xavier A, Majjhoo A, Urra X, Amaro S, Blasco J, Chamorro Á, Chirife O, Llull L, López A, Macho J, Macías N, Obach V, Renú A, Rudilosso S, San Roman L, Werner M, Turjman F, Ameli R, Berthezene Y, Chamard L, Cho T, Derex L, Gory B, Hermier M, Labeyrie P, Louis-Tisserand G, Mechtouff L, Nighoghossian N, Ong E, Riva R, Hill M, Goyal M, Jansen O, Gress D, Hetts S, Malisch T, Rai A, Sheth K, Berry S.

Author information

1
From the Marcus Stroke and Neuroscience Center, Grady Memorial Hospital, and the Department of Neurology, Emory University School of Medicine, Atlanta (R.G.N., D.C.H., M.R.F.); the Stroke Institute, Departments of Neurology (A.P.J., T.G.J.) and Neurosurgery (B.T.J.), University of Pittsburgh Medical Center, Pittsburgh, and Abington Health, Abington (Q.A.S.) - both in Pennsylvania; the Department of Neuroradiology, Hôpital Gui-de-Chauliac, Montpellier (A.B., V.C.), and the Department of Diagnostic and Therapeutic Neuroradiology (C.C.) and the Neuroimaging Center and Center for Clinical Investigations (J.-M.O.), University Hospital of Toulouse, Toulouse - both in France; OhioHealth Riverside Methodist Hospital, Columbus (R.F.B., N.A.V.), and University Hospitals of Cleveland, Cleveland (C.A.S., A.J.F.) - both in Ohio; Texas Stroke Institute, Dallas-Fort Worth (P.B., A.J.Y.), the Department of Neuroscience, Valley Baptist Medical Center, Harlingen (A.E.H., W.G.T.), and Berry Consultants, Austin (T.G., R.J.L.) - all in Texas; the Department of Neurology and Neurosurgery, University of Miami Miller School of Medicine-Jackson Memorial Hospital, Miami (D.R.Y., A.M.M.), Baptist Health, Jacksonville (R.A.H., A.A.), Memorial Regional Hospital, Hollywood (B.P.M.), and Florida Hospital, Orlando (F.R.H.) - all in Florida; the Stroke Unit, Hospital Vall d'Hebrón (M. Ribo, M. Rubiera), and Hospital Universitari de Bellvitge (P.C.), Barcelona, and the Department of Neuroscience, Hospital Germans Trias i Pujol, Universitat Autònoma de Barcelona, Badalona (M.M.) - all in Spain; the Department of Neurosurgery, State University of New York at Buffalo, Buffalo (E.I.L.); the Department of Interventional Neuroradiology, Royal Melbourne Hospital, Victoria (P.M.); the Departments of Neurology (M.C.) and Neurosurgery (D.K.L.), Rush University Medical Center, Chicago; California Pacific Medical Center (J.D.E.) and the Department of Neurology, University of California, San Francisco (W.S.S.), San Francisco, the Department of Neuroradiology, Kaiser Permanente (L.F.), and the Neurovascular Imaging Research Core, Department of Neurology and Comprehensive Stroke Center (D.S.L.), David Geffen School of Medicine, University of California, Los Angeles (UCLA) (D.S.L., J.L.S.), Los Angeles, Stryker Neurovascular, Fremont (R.S.), and Los Angeles County Harbor-UCLA Medical Center, Torrance (R.J.L.) - all in California; the Departments of Medical Imaging and Surgery (F.L.S., V.M.P.) and Neurology (V.M.P.), Toronto Western Hospital, University Health Network, University of Toronto, Toronto; the Department of Radiology, Erlanger Hospital at the University of Tennessee, Chattanooga (B.W.B.); the Department of Neurology, University of Kansas Medical Center, Kansas City (M.G.A.); and the Neuroscience Center, Capital Health Hospital, Trenton (E.V.), and the JFK Medical Center, Edison (J.F.K.) - both in New Jersey.

Abstract

BACKGROUND:

The effect of endovascular thrombectomy that is performed more than 6 hours after the onset of ischemic stroke is uncertain. Patients with a clinical deficit that is disproportionately severe relative to the infarct volume may benefit from late thrombectomy.

METHODS:

We enrolled patients with occlusion of the intracranial internal carotid artery or proximal middle cerebral artery who had last been known to be well 6 to 24 hours earlier and who had a mismatch between the severity of the clinical deficit and the infarct volume, with mismatch criteria defined according to age (<80 years or ≥80 years). Patients were randomly assigned to thrombectomy plus standard care (the thrombectomy group) or to standard care alone (the control group). The coprimary end points were the mean score for disability on the utility-weighted modified Rankin scale (which ranges from 0 [death] to 10 [no symptoms or disability]) and the rate of functional independence (a score of 0, 1, or 2 on the modified Rankin scale, which ranges from 0 to 6, with higher scores indicating more severe disability) at 90 days.

RESULTS:

A total of 206 patients were enrolled; 107 were assigned to the thrombectomy group and 99 to the control group. At 31 months, enrollment in the trial was stopped because of the results of a prespecified interim analysis. The mean score on the utility-weighted modified Rankin scale at 90 days was 5.5 in the thrombectomy group as compared with 3.4 in the control group (adjusted difference [Bayesian analysis], 2.0 points; 95% credible interval, 1.1 to 3.0; posterior probability of superiority, >0.999), and the rate of functional independence at 90 days was 49% in the thrombectomy group as compared with 13% in the control group (adjusted difference, 33 percentage points; 95% credible interval, 24 to 44; posterior probability of superiority, >0.999). The rate of symptomatic intracranial hemorrhage did not differ significantly between the two groups (6% in the thrombectomy group and 3% in the control group, P=0.50), nor did 90-day mortality (19% and 18%, respectively; P=1.00).

CONCLUSIONS:

Among patients with acute stroke who had last been known to be well 6 to 24 hours earlier and who had a mismatch between clinical deficit and infarct, outcomes for disability at 90 days were better with thrombectomy plus standard care than with standard care alone. (Funded by Stryker Neurovascular; DAWN ClinicalTrials.gov number, NCT02142283 .).

PMID:
29129157
DOI:
10.1056/NEJMoa1706442
[Indexed for MEDLINE]
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