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A Randomized Trial of Intraarterial Treatment for Acute Ischemic Stroke

Open access
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.·2015·New England Journal of Medicine

Abstract

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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Authors
Berkhemer, O. A., Fransen, P. S. S., Beumer, D., van den Berg, L. A., Lingsma, H. F., Yoo, A. J., Schonewille, W. J., Vos, J. A., Nederkoorn, P. J., Wermer, M. J. H., van Walderveen, M. A. A., Staals, J., Hofmeijer, J., van Oostayen, J. A., Lycklama à Nijeholt, G. J., Boiten, J., Brouwer, P. A., Emmer, B. J., de Bruijn, S. F., van Dijk, L. C., Kappelle, L. J., Lo, R. H., van Dijk, E. J., de Vries, J., de Kort, P. L. M., van Rooij, W. J. J., van den Berg, J. S. P., van Hasselt, B. A. A. M., Aerden, L. A. M., Dallinga, R. J., Visser, M. C., Bot, J. C. J., Vroomen, P. C., Eshghi, O., Schreuder, T. H. C. M. L., Heijboer, R. J. J., Keizer, K., Tielbeek, A. V., den Hertog, H. M., Gerrits, D. G., van den Berg-Vos, R. M., Karas, G. B., Steyerberg, E. W., Flach, H. Z., Marquering, H. A., Sprengers, M. E. S., Jenniskens, S. F. M., Beenen, L. F. M., van den Berg, R., Koudstaal, P. J., van Zwam, W. H., Roos, Y. B. W. E. M., van der Lugt, A., van Oostenbrugge, R. J., Majoie, C. B. L. M., & Dippel, D. W. J.
Venue
New England Journal of Medicine
Published
2015-01-01
Volume
372
Issue
1
Pages
11-20
ISSN
  • 0028-4793 (ISSN-L)
  • 1533-4406
OpenAlex
W2139621750
Cited by
6,657
References
6
FWCI
424.24
Type
journal article
Language
en
Open access
bronze

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Berkhemer, O. A., Fransen, P. S. S., Beumer, D., van den Berg, L. A., Lingsma, H. F., Yoo, A. J., Schonewille, W. J., Vos, J. A., Nederkoorn, P. J., Wermer, M. J. H., van Walderveen, M. A. A., Staals, J., Hofmeijer, J., van Oostayen, J. A., Lycklama à Nijeholt, G. J., Boiten, J., Brouwer, P. A., Emmer, B. J., de Bruijn, S. F., . . . Dippel, D. W. J. (2015). A Randomized Trial of Intraarterial Treatment for Acute Ischemic Stroke. New England Journal of Medicine. https://doi.org/10.1056/nejmoa1411587

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Contains information from the Semantic Scholar Academic Graph Datasets, made available under the ODC Attribution License (ODC-BY 1.0).

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