Abstract Background and aims The DISTAL trial showed no difference in rates of disability and death at 90 days in people with medium or distal vessel occlusion (MDVO) stroke treated with endovascular treatment (EVT) plus best medical treatment (BMT) versus BMT alone. We investigated the safety and efficacy of EVT plus BMT at 1 year in people enrolled in the DISTAL trial. Methods DISTAL was an open-label, blinded endpoint, randomized trial at 55 hospitals. We randomly assigned (1: 1 ratio) people with an isolated MDVO within 24 hours of last seen well to either EVT plus BMT or BMT alone. The primary outcome was the level of disability as assessed with the modified Rankin Scale (mRS) at 90 days. Here, we report the prespecified 12-month follow-up analyses for the level of disability, health related quality of life and overall survival. Results A total of 543 participants (44% female, median age 77 years) were assigned to either EVT plus BMT (271 participants) or BMT alone (272 participants). One-year data was available for 524 (96. 5%) participants. When comparing the EVT plus BMT and BMT alone groups, no significant difference in the mRS distribution at 365 days between the two groups was observed (common odds ratio (OR) 0. 90; 95% confidence interval CI 0. 67–1. 22; p=0. 50). Death from any cause (19. 6% vs 15. 1%) was similar in both groups. Conclusions In people with medium or distal vessel occlusion stroke, endovascular treatment did not reduce disability and death at one year compared to best medical treatment alone. Conflict of interest Alex Brehm: nothing to disclose Marios Psychogios: received research grants from the Swiss National Science Foundation (SNF) and Bangerter-Rhyner Stiftung, received unrestricted grant support from Medtronic Inc. , Rapid Medical Inc. , Penumbra Inc. , Siemens Healthineers AG, Stryker Neurovascular Inc. , Phenox GmbH (paid to institution), received speaker fees from Stryker Neurovascular Inc. , Medtronic Inc. , Penumbra Inc. , Acandis GmbH, Phenox GmbH, Rapid Medical Inc. , Siemens Healthineers AG (paid to institution) and is Sponsor-PI of the DISTAL Trial, SPINNERS Trial, ICARUS Trial. Urs Fischer: research support of the Swiss National Science Foundation and the State Secretariat for Education, Research and Innovation; research support of the Swiss Heart Foundation, the Swiss Brain League and the Horton Foundation; research grants from Medtronic and from Stryker, Rapid medical, Penumbra, Medtronic and Phenox, Boehringer Ingelheim; consultancies for Medtronic, Bayer, Boehringer Ingelheim, Boston Scientific, CSL Behring, Merck, Siemens and Takeda (fees paid to institution). Participation in an advisory board for AstraZeneca (former Alexion/Portola), Auzone, Biogen, AbbVie, Siemens, Corxel (fees paid to institution). Member of a clinical event committee (CEC) of the COATING study (Phenox). Member of the data and safety monitoring committee (DSMB) of the TITAN, RESCIND, LATEMT, IN EXTREMIS and RapidPulse trials. Past president of the Swiss Neurological Society and president-elect of the European Stroke Organisation. Steven Hadju: Nothing to disclose, Daniel Kaiser: Nothing to disclose; Nikki Rommers: Nothing to Disclose. Marc Ribo: Consultant for AptaTargets, Cerenovus, Medtronic Mind Med Inc, Philips, Rapid Pulse, Stryker, Vesalio. Julia Staals: Speaker Fee Medtronic. Daniel Stribian: Consultant AstraZeneca AB, Grant Boeringer Ingelheim. Juan Arenillas: Consultant for AstraZeneca, Daiichi Sankyo Company, Pfizer and Medtronic, Grants from AstraZeneca, European Commission, Gerencia de Salud Castilla y León Figure 1 - belongs to Conclusions
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Urs Fischer
Alex Brehm
Marc Ribo
European Stroke Journal
Maastricht University
Helsinki University Hospital
University Hospital of Bern
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Fischer et al. (Fri,) studied this question.
www.synapsesocial.com/papers/69fd7f0dbfa21ec5bbf076b8 — DOI: https://doi.org/10.1093/esj/aakag023.547