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Войти в исследования A randomized trial of intraarterial treatment for acute ischemic stroke.
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Berkhemer Olvert A, Fransen Puck S S, Beumer Debbie, van den Berg Lucie A, Lingsma Hester F, Yoo Albert J, Schonewille Wouter J, Vos Jan Albert, Nederkoorn Paul J, Wermer Marieke J H, van Walderveen Marianne A A, Staals Julie, Hofmeijer Jeannette, van Oostayen Jacques A, Lycklama à Nijeholt Geert J, Boiten Jelis, Brouwer Patrick A, Emmer Bart J, de Bruijn Sebastiaan F, van Dijk Lukas C, Kappelle L Jaap, Lo Rob H, van Dijk Ewoud J, de Vries Joost, de Kort Paul L M, van Rooij Willem Jan J, van den Berg Jan S P, van Hasselt Boudewijn A A M, Aerden Leo A M, Dallinga René J, Visser Marieke C, Bot Joseph C J, Vroomen Patrick C, Eshghi Omid, Schreuder Tobien H C M L, Heijboer Roel J J, Keizer Koos, Tielbeek Alexander V, den Hertog Heleen M, Gerrits Dick G, van den Berg-Vos Renske M, Karas Giorgos B, Steyerberg Ewout W, Flach H Zwenneke, Marquering Henk A, Sprengers Marieke E S, Jenniskens Sjoerd F M, Beenen Ludo F M, van den Berg René, Koudstaal Peter J, van Zwam Wim H, Roos Yvo B W E M, van der Lugt Aad, van Oostenbrugge Robert J, Majoie Charles B L M, Dippel Diederik W J, MR CLEAN Investigators
Аннотация
METHODS: We randomly assigned eligible patients to either intraarterial treatment plus usual care or usual care alone. Eligible patients had a proximal arterial occlusion in the anterior cerebral circulation that was confirmed on vessel imaging and that could be treated intraarterially within 6 hours after symptom onset. The primary outcome was the modified Rankin scale score at 90 days; this categorical scale measures functional outcome, with scores ranging from 0 (no symptoms) to 6 (death). The treatment effect was estimated with ordinal logistic regression as a common odds ratio, adjusted for prespecified prognostic factors. The adjusted common odds ratio measured the likelihood that intraarterial treatment would lead to lower modified Rankin scores, as compared with usual care alone (shift analysis).
RESULTS: We enrolled 500 patients at 16 medical centers in The Netherlands (233 assigned to intraarterial treatment and 267 to usual care alone). The mean age was 65 years (range, 23 to 96), and 445 patients (89.0%) were treated with intravenous alteplase before randomization. Retrievable stents were used in 190 of the 233 patients (81.5%) assigned to intraarterial treatment. The adjusted common odds ratio was 1.67 (95% confidence interval [CI], 1.21 to 2.30). There was an absolute difference of 13.5 percentage points (95% CI, 5.9 to 21.2) in the rate of functional independence (modified Rankin score, 0 to 2) in favor of the intervention (32.6% vs. 19.1%). There were no significant differences in mortality or the occurrence of symptomatic intracerebral hemorrhage.
CONCLUSIONS: In patients with acute ischemic stroke caused by a proximal intracranial occlusion of the anterior circulation, intraarterial treatment administered within 6 hours after stroke onset was effective and safe. (Funded by the Dutch Heart Foundation and others; MR CLEAN Netherlands Trial Registry number, NTR1804, and Current Controlled Trials number, ISRCTN10888758.).