A Randomized Trial of Intraarterial Treatment for Acute Ischemic Stroke

O. A. Berkhemer; P. S. S. Fransen; D. Beumer; L. A. van den Berg; H. F. Lingsma; A. J. Yoo; W. J. Schonewille; J. A. Vos; P. J. Nederkoorn; M. J. H. Wermer; M. A. A. van Walderveen; J. Staals; J. Hofmeijer; J. A. van Oostayen; G. J. Lycklama A. Nijeholt; J. Boiten; P. A. Brouwer; B. J. Emmer; S. F. de Bruijn; L. C. van Dijk; L. J. Kappelle; R. H. Lo; E. J. Van Dijk; J. de Vries; P. L. M. de Kort; W. J. J. van Rooij; J. S. P. van den Berg; B. A. A. M. van Hasselt; L. A. M. Aerden; R. J. Dallinga; M. C. Visser; J. C. J. Bot; P. C. Vroomen; O. Eshghi; T. H. C. M. L. Schreuder; R. J. J. Heijboer; K. Keizer; A. V. Tielbeek; H. M. den Hertog; D. G. Gerrits; R. M. van den Berg-Vos; G. B. Karas; E. W. Steyerberg; H. Z. Flach; H. A. Marquering; M. E. S. Sprengers; S. F. M. Jenniskens; L. F. M. Beenen; R. van den Berg; P. J. Koudstaal; W. H. van Zwam; Y. B. W. E. M. Roos; A. van der Lugt; R. J. van Oostenbrugge; C. B. L. M. Majoie; D. W. J. Dippel

doi:10.1056/NEJMoa1411587

A Randomized Trial of Intraarterial Treatment for Acute Ischemic Stroke

O. A. Berkhemer, P. S. S. Fransen, D. Beumer, L. A. van den Berg, H. F. Lingsma, A. J. Yoo, W. J. Schonewille, J. A. Vos, P. J. Nederkoorn, M. J. H. Wermer, M. A. A. van Walderveen, J. Staals, J. Hofmeijer, J. A. van Oostayen, G. J. Lycklama A. Nijeholt, J. Boiten, P. A. Brouwer, B. J. Emmer, S. F. de Bruijn, L. C. van DijkL. J. Kappelle, R. H. Lo, E. J. Van Dijk, J. de Vries, P. L. M. de Kort, W. J. J. van Rooij, J. S. P. van den Berg, B. A. A. M. van Hasselt, L. A. M. Aerden, R. J. Dallinga, M. C. Visser, J. C. J. Bot, P. C. Vroomen, O. Eshghi, T. H. C. M. L. Schreuder, R. J. J. Heijboer, K. Keizer, A. V. Tielbeek, H. M. den Hertog, D. G. Gerrits, R. M. van den Berg-Vos, G. B. Karas, E. W. Steyerberg, H. Z. Flach, H. A. Marquering, M. E. S. Sprengers, S. F. M. Jenniskens, L. F. M. Beenen, R. van den Berg, P. J. Koudstaal, W. H. van Zwam, Y. B. W. E. M. Roos, A. van der Lugt, R. J. van Oostenbrugge, C. B. L. M. Majoie, D. W. J. Dippel^*

^*Corresponding author for this work

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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.)

Original language	English
Pages (from-to)	11-20
Journal	New England Journal of Medicine
Volume	372
Issue number	1
DOIs	https://doi.org/10.1056/NEJMoa1411587
Publication status	Published - 1 Jan 2015

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10.1056/NEJMoa1411587

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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., Nijeholt, G. J. L. A., 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, 372(1), 11-20. https://doi.org/10.1056/NEJMoa1411587

@article{13581a2e83a94356aed911c003394077,

title = "A Randomized Trial of Intraarterial Treatment for Acute Ischemic Stroke",

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.)",

author = "Berkhemer, {O. A.} and Fransen, {P. S. S.} and D. Beumer and {van den Berg}, {L. A.} and Lingsma, {H. F.} and Yoo, {A. J.} and Schonewille, {W. J.} and Vos, {J. A.} and Nederkoorn, {P. J.} and Wermer, {M. J. H.} and {van Walderveen}, {M. A. A.} and J. Staals and J. Hofmeijer and {van Oostayen}, {J. A.} and Nijeholt, {G. J. Lycklama A.} and J. Boiten and Brouwer, {P. A.} and Emmer, {B. J.} and {de Bruijn}, {S. F.} and {van Dijk}, {L. C.} and Kappelle, {L. J.} and Lo, {R. H.} and {Van Dijk}, {E. J.} and {de Vries}, J. and {de Kort}, {P. L. M.} and {van Rooij}, {W. J. J.} and {van den Berg}, {J. S. P.} and {van Hasselt}, {B. A. A. M.} and Aerden, {L. A. M.} and Dallinga, {R. J.} and Visser, {M. C.} and Bot, {J. C. J.} and Vroomen, {P. C.} and O. Eshghi and Schreuder, {T. H. C. M. L.} and Heijboer, {R. J. J.} and K. Keizer and Tielbeek, {A. V.} and {den Hertog}, {H. M.} and Gerrits, {D. G.} and {van den Berg-Vos}, {R. M.} and Karas, {G. B.} and Steyerberg, {E. W.} and Flach, {H. Z.} and Marquering, {H. A.} and Sprengers, {M. E. S.} and Jenniskens, {S. F. M.} and Beenen, {L. F. M.} and {van den Berg}, R. and Koudstaal, {P. J.} and {van Zwam}, {W. H.} and Roos, {Y. B. W. E. M.} and {van der Lugt}, A. and {van Oostenbrugge}, {R. J.} and Majoie, {C. B. L. M.} and Dippel, {D. W. J.}",

year = "2015",

month = jan,

day = "1",

doi = "10.1056/NEJMoa1411587",

language = "English",

volume = "372",

pages = "11--20",

journal = "New England Journal of Medicine",

issn = "0028-4793",

publisher = "MASSACHUSETTS MEDICAL SOCIETY",

number = "1",

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Berkhemer, OA, Fransen, PSS, Beumer, D, van den Berg, LA, Lingsma, HF, Yoo, AJ, Schonewille, WJ, Vos, JA, Nederkoorn, PJ, Wermer, MJH, van Walderveen, MAA, Staals, J, Hofmeijer, J, van Oostayen, JA, Nijeholt, GJLA, Boiten, J, Brouwer, PA, Emmer, BJ, de Bruijn, SF, van Dijk, LC, Kappelle, LJ, Lo, RH, Van Dijk, EJ, de Vries, J, de Kort, PLM, van Rooij, WJJ, van den Berg, JSP, van Hasselt, BAAM, Aerden, LAM, Dallinga, RJ, Visser, MC, Bot, JCJ, Vroomen, PC, Eshghi, O, Schreuder, THCML, Heijboer, RJJ, Keizer, K, Tielbeek, AV, den Hertog, HM, Gerrits, DG, van den Berg-Vos, RM, Karas, GB, Steyerberg, EW, Flach, HZ, Marquering, HA, Sprengers, MES, Jenniskens, SFM, Beenen, LFM, van den Berg, R, Koudstaal, PJ, van Zwam, WH, Roos, YBWEM, van der Lugt, A, van Oostenbrugge, RJ, Majoie, CBLM & Dippel, DWJ 2015, 'A Randomized Trial of Intraarterial Treatment for Acute Ischemic Stroke', New England Journal of Medicine, vol. 372, no. 1, pp. 11-20. https://doi.org/10.1056/NEJMoa1411587

TY - JOUR

T1 - A Randomized Trial of Intraarterial Treatment for Acute Ischemic Stroke

AU - Berkhemer, O. A.

AU - Fransen, P. S. S.

AU - Beumer, D.

AU - van den Berg, L. A.

AU - Lingsma, H. F.

AU - Yoo, A. J.

AU - Schonewille, W. J.

AU - Vos, J. A.

AU - Nederkoorn, P. J.

AU - Wermer, M. J. H.

AU - van Walderveen, M. A. A.

AU - Staals, J.

AU - Hofmeijer, J.

AU - van Oostayen, J. A.

AU - Nijeholt, G. J. Lycklama A.

AU - Boiten, J.

AU - Brouwer, P. A.

AU - Emmer, B. J.

AU - de Bruijn, S. F.

AU - van Dijk, L. C.

AU - Kappelle, L. J.

AU - Lo, R. H.

AU - Van Dijk, E. J.

AU - de Vries, J.

AU - de Kort, P. L. M.

AU - van Rooij, W. J. J.

AU - van den Berg, J. S. P.

AU - van Hasselt, B. A. A. M.

AU - Aerden, L. A. M.

AU - Dallinga, R. J.

AU - Visser, M. C.

AU - Bot, J. C. J.

AU - Vroomen, P. C.

AU - Eshghi, O.

AU - Schreuder, T. H. C. M. L.

AU - Heijboer, R. J. J.

AU - Keizer, K.

AU - Tielbeek, A. V.

AU - den Hertog, H. M.

AU - Gerrits, D. G.

AU - van den Berg-Vos, R. M.

AU - Karas, G. B.

AU - Steyerberg, E. W.

AU - Flach, H. Z.

AU - Marquering, H. A.

AU - Sprengers, M. E. S.

AU - Jenniskens, S. F. M.

AU - Beenen, L. F. M.

AU - van den Berg, R.

AU - Koudstaal, P. J.

AU - van Zwam, W. H.

AU - Roos, Y. B. W. E. M.

AU - van der Lugt, A.

AU - van Oostenbrugge, R. J.

AU - Majoie, C. B. L. M.

AU - Dippel, D. W. J.

PY - 2015/1/1

Y1 - 2015/1/1

N2 - 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.)

AB - 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.)

U2 - 10.1056/NEJMoa1411587

DO - 10.1056/NEJMoa1411587

M3 - Article

C2 - 25517348

SN - 0028-4793

VL - 372

SP - 11

EP - 20

JO - New England Journal of Medicine

JF - New England Journal of Medicine

IS - 1

ER -