COMPARATIVE STUDY
JOURNAL ARTICLE
MULTICENTER STUDY
RANDOMIZED CONTROLLED TRIAL

A randomized trial of intraarterial treatment for acute ischemic stroke

Olvert A Berkhemer, Puck S S Fransen, Debbie Beumer, Lucie A van den Berg, Hester F Lingsma, Albert J Yoo, Wouter J Schonewille, Jan Albert Vos, Paul J Nederkoorn, Marieke J H Wermer, Marianne A A van Walderveen, Julie Staals, Jeannette Hofmeijer, Jacques A van Oostayen, Geert J Lycklama à Nijeholt, Jelis Boiten, Patrick A Brouwer, Bart J Emmer, Sebastiaan F de Bruijn, Lukas C van Dijk, L Jaap Kappelle, Rob H Lo, Ewoud J van Dijk, Joost de Vries, Paul L M de Kort, Willem Jan J van Rooij, Jan S P van den Berg, Boudewijn A A M van Hasselt, Leo A M Aerden, René J Dallinga, Marieke C Visser, Joseph C J Bot, Patrick C Vroomen, Omid Eshghi, Tobien H C M L Schreuder, Roel J J Heijboer, Koos Keizer, Alexander V Tielbeek, Heleen M den Hertog, Dick G Gerrits, Renske M van den Berg-Vos, Giorgos B Karas, Ewout W Steyerberg, H Zwenneke Flach, Henk A Marquering, Marieke E S Sprengers, Sjoerd F M Jenniskens, Ludo F M Beenen, René van den Berg, Peter J Koudstaal, Wim H van Zwam, Yvo B W E M Roos, Aad van der Lugt, Robert J van Oostenbrugge, Charles B L M Majoie, Diederik W J Dippel
New England Journal of Medicine 2015 January 1, 372 (1): 11-20
25517348

BACKGROUND: In patients with acute ischemic stroke caused by a proximal intracranial arterial occlusion, intraarterial treatment is highly effective for emergency revascularization. However, proof of a beneficial effect on functional outcome is lacking.

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.).

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