A Randomized Trial of Intraarterial Treatment for Acute Ischemic Stroke

Olvert Berkhemer; Puck Fransen; Debbie Beumer; LA van den Berg; Hester Lingsma; AJ Yoo; WJ Schonewille; JA Vos; PJ Nederkoorn; MJH Wermer; MAA Walderveen; J Staals; J Hofmeijer; JA van Oostayen; GJLA Nijeholt; J Boiten; Patrick Brouwer; Bart Emmer; SF de Bruijn; LC van Dijk; LJ Kappelle; RH Lo; EJ van Dijk; J de Vries; PLM de Kort; WJJ Rooij; JSP van den Berg; BAAM van Hasselt; LAM Aerden; RJ Dallinga; MC Visser; JCJ Bot; PC Vroomen; O Eshghi; THCML Schreuder; RJJ Heijboer; K Keizer; AV Tielbeek; HM den Hertog; DG Gerrits; RM van den Berg-Vos; GB Karas; Ewout Steyerberg; HZ (Zwenneke) Flach; HA Marquering; MES Sprengers; SFM Jenniskens; LFM Beenen; R van den Berg; Peter Koudstaal; WH Zwam; YBWEM Roos; Aad van der Lugt; RJ van Oostenbrugge; CBLM Majoie; Diederik Dippel

doi:10.1056/NEJMoa1411587

A Randomized Trial of Intraarterial Treatment for Acute Ischemic Stroke

Olvert Berkhemer, Puck Fransen, Debbie Beumer, LA van den Berg, Hester Lingsma, AJ Yoo, WJ Schonewille, JA Vos, PJ Nederkoorn, MJH Wermer, MAA Walderveen, J Staals, J Hofmeijer, JA van Oostayen, GJLA Nijeholt, J Boiten, Patrick Brouwer, Bart Emmer, SF de Bruijn, LC van DijkLJ Kappelle, RH Lo, EJ van Dijk, J de Vries, PLM de Kort, WJJ Rooij, JSP van den Berg, BAAM van Hasselt, LAM Aerden, RJ Dallinga, MC Visser, JCJ Bot, PC Vroomen, O Eshghi, THCML Schreuder, RJJ Heijboer, K Keizer, AV Tielbeek, HM den Hertog, DG Gerrits, RM van den Berg-Vos, GB Karas, Ewout Steyerberg, HZ (Zwenneke) Flach, HA Marquering, MES Sprengers, SFM Jenniskens, LFM Beenen, R van den Berg, Peter Koudstaal, WH Zwam, YBWEM Roos, Aad van der Lugt, RJ van Oostenbrugge, CBLM Majoie, Diederik Dippel

Research output: Contribution to journal › Article › Academic › peer-review

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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	Undefined/Unknown
Pages (from-to)	11-20
Number of pages	10
Journal	New England Journal of Medicine
Volume	372
Issue number	1
DOIs	https://doi.org/10.1056/NEJMoa1411587
Publication status	Published - 2015

Research programs

EMC COEUR-09
EMC NIHES-02-65-01
EMC NIHES-03-30-01

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10.1056/NEJMoa1411587

http://hdl.handle.net/1765/91612

Cite this

Berkhemer, O., Fransen, P., Beumer, D., van den Berg, LA., Lingsma, H., Yoo, AJ., Schonewille, WJ., Vos, JA., Nederkoorn, PJ., Wermer, MJH., Walderveen, MAA., Staals, J., Hofmeijer, J., van Oostayen, JA., Nijeholt, GJLA., Boiten, J., Brouwer, P., Emmer, B., de Bruijn, SF., ... Dippel, D. (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{d64ad616817645fd9d8389fe396bb540,

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 = "Olvert Berkhemer and Puck Fransen and Debbie Beumer and {van den Berg}, LA and Hester Lingsma and AJ Yoo and WJ Schonewille and JA Vos and PJ Nederkoorn and MJH Wermer and MAA Walderveen and J Staals and J Hofmeijer and {van Oostayen}, JA and GJLA Nijeholt and J Boiten and Patrick Brouwer and Bart Emmer and {de Bruijn}, SF and {van Dijk}, LC and LJ Kappelle and RH Lo and {van Dijk}, EJ and {de Vries}, J and {de Kort}, PLM and WJJ Rooij and {van den Berg}, JSP and {van Hasselt}, BAAM and LAM Aerden and RJ Dallinga and MC Visser and JCJ Bot and PC Vroomen and O Eshghi and THCML Schreuder and RJJ Heijboer and K Keizer and AV Tielbeek and {den Hertog}, HM and DG Gerrits and {van den Berg-Vos}, RM and GB Karas and Ewout Steyerberg and Flach, {HZ (Zwenneke)} and HA Marquering and MES Sprengers and SFM Jenniskens and LFM Beenen and {van den Berg}, R and Peter Koudstaal and WH Zwam and YBWEM Roos and {van der Lugt}, Aad and {van Oostenbrugge}, RJ and CBLM Majoie and Diederik Dippel",

year = "2015",

doi = "10.1056/NEJMoa1411587",

language = "Undefined/Unknown",

volume = "372",

pages = "11--20",

journal = "New England Journal of Medicine",

issn = "0028-4793",

publisher = "Massachussetts Medical Society",

number = "1",

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Berkhemer, O, Fransen, P, Beumer, D, van den Berg, LA, Lingsma, H, Yoo, AJ, Schonewille, WJ, Vos, JA, Nederkoorn, PJ, Wermer, MJH, Walderveen, MAA, Staals, J, Hofmeijer, J, van Oostayen, JA, Nijeholt, GJLA, Boiten, J, Brouwer, P, Emmer, B, de Bruijn, SF, van Dijk, LC, Kappelle, LJ, Lo, RH, van Dijk, EJ, de Vries, J, de Kort, PLM, 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, E, Flach, HZ, Marquering, HA, Sprengers, MES, Jenniskens, SFM, Beenen, LFM, van den Berg, R, Koudstaal, P, Zwam, WH, Roos, YBWEM, van der Lugt, A, van Oostenbrugge, RJ, Majoie, CBLM & Dippel, D 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, Olvert

AU - Fransen, Puck

AU - Beumer, Debbie

AU - van den Berg, LA

AU - Lingsma, Hester

AU - Yoo, AJ

AU - Schonewille, WJ

AU - Vos, JA

AU - Nederkoorn, PJ

AU - Wermer, MJH

AU - Walderveen, MAA

AU - Staals, J

AU - Hofmeijer, J

AU - van Oostayen, JA

AU - Nijeholt, GJLA

AU - Boiten, J

AU - Brouwer, Patrick

AU - Emmer, Bart

AU - de Bruijn, SF

AU - van Dijk, LC

AU - Kappelle, LJ

AU - Lo, RH

AU - van Dijk, EJ

AU - de Vries, J

AU - de Kort, PLM

AU - Rooij, WJJ

AU - van den Berg, JSP

AU - van Hasselt, BAAM

AU - Aerden, LAM

AU - Dallinga, RJ

AU - Visser, MC

AU - Bot, JCJ

AU - Vroomen, PC

AU - Eshghi, O

AU - Schreuder, THCML

AU - Heijboer, RJJ

AU - Keizer, K

AU - Tielbeek, AV

AU - den Hertog, HM

AU - Gerrits, DG

AU - van den Berg-Vos, RM

AU - Karas, GB

AU - Steyerberg, Ewout

AU - Flach, HZ (Zwenneke)

AU - Marquering, HA

AU - Sprengers, MES

AU - Jenniskens, SFM

AU - Beenen, LFM

AU - van den Berg, R

AU - Koudstaal, Peter

AU - Zwam, WH

AU - Roos, YBWEM

AU - van der Lugt, Aad

AU - van Oostenbrugge, RJ

AU - Majoie, CBLM

AU - Dippel, Diederik

PY - 2015

Y1 - 2015

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 -