Randomized assessment of rapid endovascular treatment of ischemic stroke

Mayank Goyal, Andrew M. Demchuk, Bijoy K. Menon, Muneer Eesa, Jeremy L. Rempel, John Thornton, Daniel Roy, Tudor G. Jovin, Robert A. Willinsky, Biggya L. Sapkota, Dar Dowlatshahi, Donald F. Frei, Noreen R. Kamal, Walter J. Montanera, Alexandre Y. Poppe, Karla J. Ryckborst, Frank L. Silver, Ashfaq Shuaib, Donatella Tampieri, David WilliamsOh Young Bang, Blaise W. Baxter, Paul A. Burns, Hana Choe, Ji Hoe Heo, Christine A. Holmstedt, Brian Jankowitz, Michael Kelly, Guillermo Linares, Jennifer L. Mandzia, Jai Shankar, Sung Il Sohn, Richard H. Swartz, Philip A. Barber, Shelagh B. Coutts, Eric E. Smith, William F. Morrish, Alain Weill, Suresh Subramaniam, Alim P. Mitha, John H. Wong, Mark W. Lowerison, Tolulope T. Sajobi, M. D. Hill

Research output: Contribution to journalArticle

2500 Citations (Scopus)

Abstract

Background: Among patients with a proximal vessel occlusion in the anterior circulation, 60 to 80% of patients die within 90 days after stroke onset or do not regain functional independence despite alteplase treatment. We evaluated rapid endovascular treatment in addition to standard care in patients with acute ischemic stroke with a small infarct core, a proximal intracranial arterial occlusion, and moderate-to-good collateral circulation. Methods: We randomly assigned participants to receive standard care (control group) or standard care plus endovascular treatment with the use of available thrombectomy devices (intervention group). Patients with a proximal intracranial occlusion in the anterior circulation were included up to 12 hours after symptom onset. Patients with a large infarct core or poor collateral circulation on computed tomography (CT) and CT angiography were excluded. Workflow times were measured against predetermined targets. The primary outcome was the score on the modified Rankin scale (range, 0 [no symptoms] to 6 [death]) at 90 days. A proportional odds model was used to calculate the common odds ratio as a measure of the likelihood that the intervention would lead to lower scores on the modified Rankin scale than would control care (shift analysis). Results: The trial was stopped early because of efficacy. At 22 centers worldwide, 316 participants were enrolled, of whom 238 received intravenous alteplase (120 in the intervention group and 118 in the control group). In the intervention group, the median time from study CT of the head to first reperfusion was 84 minutes. The rate of functional independence (90-day modified Rankin score of 0 to 2) was increased with the intervention (53.0%, vs. 29.3% in the control group; P<0.001). The primary outcome favored the intervention (common odds ratio, 2.6; 95% confidence interval, 1.7 to 3.8; P<0.001), and the intervention was associated with reduced mortality (10.4%, vs. 19.0% in the control group; P = 0.04). Symptomatic intracerebral hemorrhage occurred in 3.6% of participants in intervention group and 2.7% of participants in control group (P = 0.75). Conclusions: Among patients with acute ischemic stroke with a proximal vessel occlusion, a small infarct core, and moderate-to-good collateral circulation, rapid endovascular treatment improved functional outcomes and reduced mortality. (Funded by Covidien and others; ESCAPE ClinicalTrials.gov number, NCT01778335.)

Original languageEnglish
Pages (from-to)1019-1030
Number of pages12
JournalNew England Journal of Medicine
Volume372
Issue number11
DOIs
Publication statusPublished - 2015 Mar 12

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Stroke
Collateral Circulation
Control Groups
Tissue Plasminogen Activator
Odds Ratio
Tomography
Therapeutics
Thrombectomy
Time and Motion Studies
Workflow
Mortality
Cerebral Hemorrhage
Reperfusion
Patient Care
Head
Confidence Intervals
Equipment and Supplies

All Science Journal Classification (ASJC) codes

  • Medicine(all)

Cite this

Goyal, M., Demchuk, A. M., Menon, B. K., Eesa, M., Rempel, J. L., Thornton, J., ... Hill, M. D. (2015). Randomized assessment of rapid endovascular treatment of ischemic stroke. New England Journal of Medicine, 372(11), 1019-1030. https://doi.org/10.1056/NEJMoa1414905
Goyal, Mayank ; Demchuk, Andrew M. ; Menon, Bijoy K. ; Eesa, Muneer ; Rempel, Jeremy L. ; Thornton, John ; Roy, Daniel ; Jovin, Tudor G. ; Willinsky, Robert A. ; Sapkota, Biggya L. ; Dowlatshahi, Dar ; Frei, Donald F. ; Kamal, Noreen R. ; Montanera, Walter J. ; Poppe, Alexandre Y. ; Ryckborst, Karla J. ; Silver, Frank L. ; Shuaib, Ashfaq ; Tampieri, Donatella ; Williams, David ; Bang, Oh Young ; Baxter, Blaise W. ; Burns, Paul A. ; Choe, Hana ; Heo, Ji Hoe ; Holmstedt, Christine A. ; Jankowitz, Brian ; Kelly, Michael ; Linares, Guillermo ; Mandzia, Jennifer L. ; Shankar, Jai ; Sohn, Sung Il ; Swartz, Richard H. ; Barber, Philip A. ; Coutts, Shelagh B. ; Smith, Eric E. ; Morrish, William F. ; Weill, Alain ; Subramaniam, Suresh ; Mitha, Alim P. ; Wong, John H. ; Lowerison, Mark W. ; Sajobi, Tolulope T. ; Hill, M. D. / Randomized assessment of rapid endovascular treatment of ischemic stroke. In: New England Journal of Medicine. 2015 ; Vol. 372, No. 11. pp. 1019-1030.
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abstract = "Background: Among patients with a proximal vessel occlusion in the anterior circulation, 60 to 80{\%} of patients die within 90 days after stroke onset or do not regain functional independence despite alteplase treatment. We evaluated rapid endovascular treatment in addition to standard care in patients with acute ischemic stroke with a small infarct core, a proximal intracranial arterial occlusion, and moderate-to-good collateral circulation. Methods: We randomly assigned participants to receive standard care (control group) or standard care plus endovascular treatment with the use of available thrombectomy devices (intervention group). Patients with a proximal intracranial occlusion in the anterior circulation were included up to 12 hours after symptom onset. Patients with a large infarct core or poor collateral circulation on computed tomography (CT) and CT angiography were excluded. Workflow times were measured against predetermined targets. The primary outcome was the score on the modified Rankin scale (range, 0 [no symptoms] to 6 [death]) at 90 days. A proportional odds model was used to calculate the common odds ratio as a measure of the likelihood that the intervention would lead to lower scores on the modified Rankin scale than would control care (shift analysis). Results: The trial was stopped early because of efficacy. At 22 centers worldwide, 316 participants were enrolled, of whom 238 received intravenous alteplase (120 in the intervention group and 118 in the control group). In the intervention group, the median time from study CT of the head to first reperfusion was 84 minutes. The rate of functional independence (90-day modified Rankin score of 0 to 2) was increased with the intervention (53.0{\%}, vs. 29.3{\%} in the control group; P<0.001). The primary outcome favored the intervention (common odds ratio, 2.6; 95{\%} confidence interval, 1.7 to 3.8; P<0.001), and the intervention was associated with reduced mortality (10.4{\%}, vs. 19.0{\%} in the control group; P = 0.04). Symptomatic intracerebral hemorrhage occurred in 3.6{\%} of participants in intervention group and 2.7{\%} of participants in control group (P = 0.75). Conclusions: Among patients with acute ischemic stroke with a proximal vessel occlusion, a small infarct core, and moderate-to-good collateral circulation, rapid endovascular treatment improved functional outcomes and reduced mortality. (Funded by Covidien and others; ESCAPE ClinicalTrials.gov number, NCT01778335.)",
author = "Mayank Goyal and Demchuk, {Andrew M.} and Menon, {Bijoy K.} and Muneer Eesa and Rempel, {Jeremy L.} and John Thornton and Daniel Roy and Jovin, {Tudor G.} and Willinsky, {Robert A.} and Sapkota, {Biggya L.} and Dar Dowlatshahi and Frei, {Donald F.} and Kamal, {Noreen R.} and Montanera, {Walter J.} and Poppe, {Alexandre Y.} and Ryckborst, {Karla J.} and Silver, {Frank L.} and Ashfaq Shuaib and Donatella Tampieri and David Williams and Bang, {Oh Young} and Baxter, {Blaise W.} and Burns, {Paul A.} and Hana Choe and Heo, {Ji Hoe} and Holmstedt, {Christine A.} and Brian Jankowitz and Michael Kelly and Guillermo Linares and Mandzia, {Jennifer L.} and Jai Shankar and Sohn, {Sung Il} and Swartz, {Richard H.} and Barber, {Philip A.} and Coutts, {Shelagh B.} and Smith, {Eric E.} and Morrish, {William F.} and Alain Weill and Suresh Subramaniam and Mitha, {Alim P.} and Wong, {John H.} and Lowerison, {Mark W.} and Sajobi, {Tolulope T.} and Hill, {M. D.}",
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Goyal, M, Demchuk, AM, Menon, BK, Eesa, M, Rempel, JL, Thornton, J, Roy, D, Jovin, TG, Willinsky, RA, Sapkota, BL, Dowlatshahi, D, Frei, DF, Kamal, NR, Montanera, WJ, Poppe, AY, Ryckborst, KJ, Silver, FL, Shuaib, A, Tampieri, D, Williams, D, Bang, OY, Baxter, BW, Burns, PA, Choe, H, Heo, JH, Holmstedt, CA, Jankowitz, B, Kelly, M, Linares, G, Mandzia, JL, Shankar, J, Sohn, SI, Swartz, RH, Barber, PA, Coutts, SB, Smith, EE, Morrish, WF, Weill, A, Subramaniam, S, Mitha, AP, Wong, JH, Lowerison, MW, Sajobi, TT & Hill, MD 2015, 'Randomized assessment of rapid endovascular treatment of ischemic stroke', New England Journal of Medicine, vol. 372, no. 11, pp. 1019-1030. https://doi.org/10.1056/NEJMoa1414905

Randomized assessment of rapid endovascular treatment of ischemic stroke. / Goyal, Mayank; Demchuk, Andrew M.; Menon, Bijoy K.; Eesa, Muneer; Rempel, Jeremy L.; Thornton, John; Roy, Daniel; Jovin, Tudor G.; Willinsky, Robert A.; Sapkota, Biggya L.; Dowlatshahi, Dar; Frei, Donald F.; Kamal, Noreen R.; Montanera, Walter J.; Poppe, Alexandre Y.; Ryckborst, Karla J.; Silver, Frank L.; Shuaib, Ashfaq; Tampieri, Donatella; Williams, David; Bang, Oh Young; Baxter, Blaise W.; Burns, Paul A.; Choe, Hana; Heo, Ji Hoe; Holmstedt, Christine A.; Jankowitz, Brian; Kelly, Michael; Linares, Guillermo; Mandzia, Jennifer L.; Shankar, Jai; Sohn, Sung Il; Swartz, Richard H.; Barber, Philip A.; Coutts, Shelagh B.; Smith, Eric E.; Morrish, William F.; Weill, Alain; Subramaniam, Suresh; Mitha, Alim P.; Wong, John H.; Lowerison, Mark W.; Sajobi, Tolulope T.; Hill, M. D.

In: New England Journal of Medicine, Vol. 372, No. 11, 12.03.2015, p. 1019-1030.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Randomized assessment of rapid endovascular treatment of ischemic stroke

AU - Goyal, Mayank

AU - Demchuk, Andrew M.

AU - Menon, Bijoy K.

AU - Eesa, Muneer

AU - Rempel, Jeremy L.

AU - Thornton, John

AU - Roy, Daniel

AU - Jovin, Tudor G.

AU - Willinsky, Robert A.

AU - Sapkota, Biggya L.

AU - Dowlatshahi, Dar

AU - Frei, Donald F.

AU - Kamal, Noreen R.

AU - Montanera, Walter J.

AU - Poppe, Alexandre Y.

AU - Ryckborst, Karla J.

AU - Silver, Frank L.

AU - Shuaib, Ashfaq

AU - Tampieri, Donatella

AU - Williams, David

AU - Bang, Oh Young

AU - Baxter, Blaise W.

AU - Burns, Paul A.

AU - Choe, Hana

AU - Heo, Ji Hoe

AU - Holmstedt, Christine A.

AU - Jankowitz, Brian

AU - Kelly, Michael

AU - Linares, Guillermo

AU - Mandzia, Jennifer L.

AU - Shankar, Jai

AU - Sohn, Sung Il

AU - Swartz, Richard H.

AU - Barber, Philip A.

AU - Coutts, Shelagh B.

AU - Smith, Eric E.

AU - Morrish, William F.

AU - Weill, Alain

AU - Subramaniam, Suresh

AU - Mitha, Alim P.

AU - Wong, John H.

AU - Lowerison, Mark W.

AU - Sajobi, Tolulope T.

AU - Hill, M. D.

PY - 2015/3/12

Y1 - 2015/3/12

N2 - Background: Among patients with a proximal vessel occlusion in the anterior circulation, 60 to 80% of patients die within 90 days after stroke onset or do not regain functional independence despite alteplase treatment. We evaluated rapid endovascular treatment in addition to standard care in patients with acute ischemic stroke with a small infarct core, a proximal intracranial arterial occlusion, and moderate-to-good collateral circulation. Methods: We randomly assigned participants to receive standard care (control group) or standard care plus endovascular treatment with the use of available thrombectomy devices (intervention group). Patients with a proximal intracranial occlusion in the anterior circulation were included up to 12 hours after symptom onset. Patients with a large infarct core or poor collateral circulation on computed tomography (CT) and CT angiography were excluded. Workflow times were measured against predetermined targets. The primary outcome was the score on the modified Rankin scale (range, 0 [no symptoms] to 6 [death]) at 90 days. A proportional odds model was used to calculate the common odds ratio as a measure of the likelihood that the intervention would lead to lower scores on the modified Rankin scale than would control care (shift analysis). Results: The trial was stopped early because of efficacy. At 22 centers worldwide, 316 participants were enrolled, of whom 238 received intravenous alteplase (120 in the intervention group and 118 in the control group). In the intervention group, the median time from study CT of the head to first reperfusion was 84 minutes. The rate of functional independence (90-day modified Rankin score of 0 to 2) was increased with the intervention (53.0%, vs. 29.3% in the control group; P<0.001). The primary outcome favored the intervention (common odds ratio, 2.6; 95% confidence interval, 1.7 to 3.8; P<0.001), and the intervention was associated with reduced mortality (10.4%, vs. 19.0% in the control group; P = 0.04). Symptomatic intracerebral hemorrhage occurred in 3.6% of participants in intervention group and 2.7% of participants in control group (P = 0.75). Conclusions: Among patients with acute ischemic stroke with a proximal vessel occlusion, a small infarct core, and moderate-to-good collateral circulation, rapid endovascular treatment improved functional outcomes and reduced mortality. (Funded by Covidien and others; ESCAPE ClinicalTrials.gov number, NCT01778335.)

AB - Background: Among patients with a proximal vessel occlusion in the anterior circulation, 60 to 80% of patients die within 90 days after stroke onset or do not regain functional independence despite alteplase treatment. We evaluated rapid endovascular treatment in addition to standard care in patients with acute ischemic stroke with a small infarct core, a proximal intracranial arterial occlusion, and moderate-to-good collateral circulation. Methods: We randomly assigned participants to receive standard care (control group) or standard care plus endovascular treatment with the use of available thrombectomy devices (intervention group). Patients with a proximal intracranial occlusion in the anterior circulation were included up to 12 hours after symptom onset. Patients with a large infarct core or poor collateral circulation on computed tomography (CT) and CT angiography were excluded. Workflow times were measured against predetermined targets. The primary outcome was the score on the modified Rankin scale (range, 0 [no symptoms] to 6 [death]) at 90 days. A proportional odds model was used to calculate the common odds ratio as a measure of the likelihood that the intervention would lead to lower scores on the modified Rankin scale than would control care (shift analysis). Results: The trial was stopped early because of efficacy. At 22 centers worldwide, 316 participants were enrolled, of whom 238 received intravenous alteplase (120 in the intervention group and 118 in the control group). In the intervention group, the median time from study CT of the head to first reperfusion was 84 minutes. The rate of functional independence (90-day modified Rankin score of 0 to 2) was increased with the intervention (53.0%, vs. 29.3% in the control group; P<0.001). The primary outcome favored the intervention (common odds ratio, 2.6; 95% confidence interval, 1.7 to 3.8; P<0.001), and the intervention was associated with reduced mortality (10.4%, vs. 19.0% in the control group; P = 0.04). Symptomatic intracerebral hemorrhage occurred in 3.6% of participants in intervention group and 2.7% of participants in control group (P = 0.75). Conclusions: Among patients with acute ischemic stroke with a proximal vessel occlusion, a small infarct core, and moderate-to-good collateral circulation, rapid endovascular treatment improved functional outcomes and reduced mortality. (Funded by Covidien and others; ESCAPE ClinicalTrials.gov number, NCT01778335.)

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U2 - 10.1056/NEJMoa1414905

DO - 10.1056/NEJMoa1414905

M3 - Article

C2 - 25671798

AN - SCOPUS:84924691962

VL - 372

SP - 1019

EP - 1030

JO - New England Journal of Medicine

JF - New England Journal of Medicine

SN - 0028-4793

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Goyal M, Demchuk AM, Menon BK, Eesa M, Rempel JL, Thornton J et al. Randomized assessment of rapid endovascular treatment of ischemic stroke. New England Journal of Medicine. 2015 Mar 12;372(11):1019-1030. https://doi.org/10.1056/NEJMoa1414905