1. Thrombectomy 6 to 24 Hours after Stroke with a Mismatch between Deficit and Infarct
- Author
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Lei Feng, Brijesh P Mehta, Cathy A. Sila, Demetrius K. Lopes, Todd Graves, Ashutosh P Jadhav, Ameer E Hassan, Erol Veznedaroglu, Amin Aghaebrahim, Dileep R. Yavagal, Elad I. Levy, David S Liebeskind, Marta Rubiera, Mónica Millán, Michael Chen, Wondwossen G Tekle, Nirav Vora, Michael Frankel, Marc Ribo, Anthony J. Furlan, Michael G. Abraham, Vitor Mendes Pereira, Vincent Costalat, Frank L. Silver, Ricardo A. Hanel, Roger J. Lewis, Jeffrey L. Saver, Wade S. Smith, Jean-Marc Olivot, Parita Bhuva, Amer M. Malik, Raul G Nogueira, Diogo C Haussen, Frank R Hellinger, Christophe Cognard, Ryan K. Shields, Pedro Cardona, Joey English, Brian T. Jankowitz, Tudor G Jovin, Albert J Yoo, Blaise Baxter, Peter Mitchell, Alain Bonafe, Jawad F. Kirmani, Qaisar A. Shah, Ronald F. Budzik, Département de Neuroradiologie[Montpellier], Université Montpellier 1 (UM1)-Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier)-Hôpital Gui de Chauliac [Montpellier]-Université de Montpellier (UM), Institut des Neurosciences de Montpellier - Déficits sensoriels et moteurs (INM), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Montpellier (UM), Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier), and Université de Montpellier (UM)
- Subjects
medicine.medical_specialty ,business.industry ,Cerebral infarction ,[SDV]Life Sciences [q-bio] ,General Medicine ,030204 cardiovascular system & hematology ,medicine.disease ,3. Good health ,Surgery ,law.invention ,03 medical and health sciences ,0302 clinical medicine ,Randomized controlled trial ,law ,Modified Rankin Scale ,medicine.artery ,Middle cerebral artery ,Occlusion ,medicine ,cardiovascular diseases ,Internal carotid artery ,business ,Stroke ,030217 neurology & neurosurgery ,Fibrinolytic agent - 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). 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.)
- Published
- 2018
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