Trial of endovascular thrombectomy for large ischemic strokes

A. Sarraj; A. E. Hassan; M. G. Abraham; S. Ortega-Gutierrez; S. E. Kasner; M. S. Hussain; M. Chen; S. Blackburn; C. W. Sitton; L. Churilov; S. Sundararajan; Y. C. Hu; N. A. Herial; P. Jabbour; D. Gibson; A. N. Wallace; J .F. Arenillas; J. P. Tsai; R. F. Budzik; W. J. Hicks; O. Kozak; B. Yan; D. J. Cordato; N. W. Manning; M. W. Parsons; R. A. Hanel; A. N. Aghaebrahim; T. Y. Wu; P. Cardona-Portela; N. Perez de la Ossa; J. D. Schaafsma; J. Blasco; N. Sangha; S. Warach; C. D. Gandhi; T. J. Kleinig; D. Sahlein; L. Elijovich; W. Tekle; E. A. Samaniego; L. Maali; M. A. Abdulrazzak; M. N. Psychogios; A. Shuaib; D. K. Pujara; F. Shaker; H. Johns; G. Sharma; V. Yogendrakumar; F. C. Ng; M. H. Rahbar; C. Cai; P. Lavori; S. Hamilton; T. Nguyen; J. T. Fifi; S. Davis; L. Wechsler; V. M. Pereira; M. G. Lansberg; M. D. Hill; J. C. Grotta; M. Ribo; B. C. Campbell; G. W. Albers

doi:10.1056/NEJMoa2214403

Trial of endovascular thrombectomy for large ischemic strokes

A. Sarraj, A. E. Hassan, M. G. Abraham, S. Ortega-Gutierrez, S. E. Kasner, M. S. Hussain, M. Chen, S. Blackburn, C. W. Sitton, L. Churilov, S. Sundararajan, Y. C. Hu, N. A. Herial, P. Jabbour, D. Gibson, A. N. Wallace, J .F. Arenillas, J. P. Tsai, R. F. Budzik, W. J. HicksO. Kozak, B. Yan, D. J. Cordato, N. W. Manning, M. W. Parsons, R. A. Hanel, A. N. Aghaebrahim, T. Y. Wu, P. Cardona-Portela, N. Perez de la Ossa, J. D. Schaafsma, J. Blasco, N. Sangha, S. Warach, C. D. Gandhi, T. J. Kleinig, D. Sahlein, L. Elijovich, W. Tekle, E. A. Samaniego, L. Maali, M. A. Abdulrazzak, M. N. Psychogios, A. Shuaib, D. K. Pujara, F. Shaker, H. Johns, G. Sharma, V. Yogendrakumar, F. C. Ng, M. H. Rahbar, C. Cai, P. Lavori, S. Hamilton, T. Nguyen, J. T. Fifi, S. Davis, L. Wechsler, V. M. Pereira, M. G. Lansberg, M. D. Hill, J. C. Grotta, M. Ribo, B. C. Campbell, G. W. Albers

Western Sydney University

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

Abstract

Abstract Background Trials of the efficacy and safety of endovascular thrombectomy in patients with large ischemic strokes have been carried out in limited populations. Methods We performed a prospective, randomized, open-label, adaptive, international trial involving patients with stroke due to occlusion of the internal carotid artery or the first segment of the middle cerebral artery to assess endovascular thrombectomy within 24 hours after onset. Patients had a large ischemic-core volume, defined as an Alberta Stroke Program Early Computed Tomography Score of 3 to 5 (range, 0 to 10, with lower scores indicating larger infarction) or a core volume of at least 50 ml on computed tomography perfusion or diffusion-weighted magnetic resonance imaging. Patients were assigned in a 1:1 ratio to endovascular thrombectomy plus medical care or to medical care alone. The primary outcome was the modified Rankin scale score at 90 days (range, 0 to 6, with higher scores indicating greater disability). Functional independence was a secondary outcome. Results The trial was stopped early for efficacy; 178 patients had been assigned to the thrombectomy group and 174 to the medical-care group. The generalized odds ratio for a shift in the distribution of modified Rankin scale scores toward better outcomes in favor of thrombectomy was 1.51 (95% confidence interval [CI], 1.20 to 1.89; P<0.001). A total of 20% of the patients in the thrombectomy group and 7% in the medical-care group had functional independence (relative risk, 2.97; 95% CI, 1.60 to 5.51). Mortality was similar in the two groups. In the thrombectomy group, arterial access-site complications occurred in 5 patients, dissection in 10, cerebral-vessel perforation in 7, and transient vasospasm in 11. Symptomatic intracranial hemorrhage occurred in 1 patient in the thrombectomy group and in 2 in the medical-care group. Conclusions Among patients with large ischemic strokes, endovascular thrombectomy resulted in better functional outcomes than medical care but was associated with vascular complications. Cerebral hemorrhages were infrequent in both groups. (Funded by Stryker Neurovascular; SELECT2 ClinicalTrials.gov number, NCT03876457.)

Original language	English
Pages (from-to)	1259-1271
Number of pages	13
Journal	New England Journal of Medicine
Volume	388
Issue number	14
DOIs	https://doi.org/10.1056/NEJMoa2214403
Publication status	Published - 2023

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10.1056/NEJMoa2214403

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Sarraj, A., Hassan, A. E., Abraham, M. G., Ortega-Gutierrez, S., Kasner, S. E., Hussain, M. S., Chen, M., Blackburn, S., Sitton, C. W., Churilov, L., Sundararajan, S., Hu, Y. C., Herial, N. A., Jabbour, P., Gibson, D., Wallace, A. N., Arenillas, J. . F., Tsai, J. P., Budzik, R. F., ... Albers, G. W. (2023). Trial of endovascular thrombectomy for large ischemic strokes. New England Journal of Medicine, 388(14), 1259-1271. https://doi.org/10.1056/NEJMoa2214403

@article{d1f7fdd6678e439db57cdc838cc1ac0e,

title = "Trial of endovascular thrombectomy for large ischemic strokes",

abstract = "Abstract Background Trials of the efficacy and safety of endovascular thrombectomy in patients with large ischemic strokes have been carried out in limited populations. Methods We performed a prospective, randomized, open-label, adaptive, international trial involving patients with stroke due to occlusion of the internal carotid artery or the first segment of the middle cerebral artery to assess endovascular thrombectomy within 24 hours after onset. Patients had a large ischemic-core volume, defined as an Alberta Stroke Program Early Computed Tomography Score of 3 to 5 (range, 0 to 10, with lower scores indicating larger infarction) or a core volume of at least 50 ml on computed tomography perfusion or diffusion-weighted magnetic resonance imaging. Patients were assigned in a 1:1 ratio to endovascular thrombectomy plus medical care or to medical care alone. The primary outcome was the modified Rankin scale score at 90 days (range, 0 to 6, with higher scores indicating greater disability). Functional independence was a secondary outcome. Results The trial was stopped early for efficacy; 178 patients had been assigned to the thrombectomy group and 174 to the medical-care group. The generalized odds ratio for a shift in the distribution of modified Rankin scale scores toward better outcomes in favor of thrombectomy was 1.51 (95% confidence interval [CI], 1.20 to 1.89; P<0.001). A total of 20% of the patients in the thrombectomy group and 7% in the medical-care group had functional independence (relative risk, 2.97; 95% CI, 1.60 to 5.51). Mortality was similar in the two groups. In the thrombectomy group, arterial access-site complications occurred in 5 patients, dissection in 10, cerebral-vessel perforation in 7, and transient vasospasm in 11. Symptomatic intracranial hemorrhage occurred in 1 patient in the thrombectomy group and in 2 in the medical-care group. Conclusions Among patients with large ischemic strokes, endovascular thrombectomy resulted in better functional outcomes than medical care but was associated with vascular complications. Cerebral hemorrhages were infrequent in both groups. (Funded by Stryker Neurovascular; SELECT2 ClinicalTrials.gov number, NCT03876457.)",

author = "A. Sarraj and Hassan, {A. E.} and Abraham, {M. G.} and S. Ortega-Gutierrez and Kasner, {S. E.} and Hussain, {M. S.} and M. Chen and S. Blackburn and Sitton, {C. W.} and L. Churilov and S. Sundararajan and Hu, {Y. C.} and Herial, {N. A.} and P. Jabbour and D. Gibson and Wallace, {A. N.} and Arenillas, {J .F.} and Tsai, {J. P.} and Budzik, {R. F.} and Hicks, {W. J.} and O. Kozak and B. Yan and Cordato, {D. J.} and Manning, {N. W.} and Parsons, {M. W.} and Hanel, {R. A.} and Aghaebrahim, {A. N.} and Wu, {T. Y.} and P. Cardona-Portela and {Perez de la Ossa}, N. and Schaafsma, {J. D.} and J. Blasco and N. Sangha and S. Warach and Gandhi, {C. D.} and Kleinig, {T. J.} and D. Sahlein and L. Elijovich and W. Tekle and Samaniego, {E. A.} and L. Maali and Abdulrazzak, {M. A.} and Psychogios, {M. N.} and A. Shuaib and Pujara, {D. K.} and F. Shaker and H. Johns and G. Sharma and V. Yogendrakumar and Ng, {F. C.} and Rahbar, {M. H.} and C. Cai and P. Lavori and S. Hamilton and T. Nguyen and Fifi, {J. T.} and S. Davis and L. Wechsler and Pereira, {V. M.} and Lansberg, {M. G.} and Hill, {M. D.} and Grotta, {J. C.} and M. Ribo and Campbell, {B. C.} and Albers, {G. W.}",

year = "2023",

doi = "10.1056/NEJMoa2214403",

language = "English",

volume = "388",

pages = "1259--1271",

journal = "New England Journal of Medicine",

issn = "0028-4793",

publisher = "Massachusetts Medical Society",

number = "14",

}

Sarraj, A, Hassan, AE, Abraham, MG, Ortega-Gutierrez, S, Kasner, SE, Hussain, MS, Chen, M, Blackburn, S, Sitton, CW, Churilov, L, Sundararajan, S, Hu, YC, Herial, NA, Jabbour, P, Gibson, D, Wallace, AN, Arenillas, JF, Tsai, JP, Budzik, RF, Hicks, WJ, Kozak, O, Yan, B, Cordato, DJ, Manning, NW, Parsons, MW, Hanel, RA, Aghaebrahim, AN, Wu, TY, Cardona-Portela, P, Perez de la Ossa, N, Schaafsma, JD, Blasco, J, Sangha, N, Warach, S, Gandhi, CD, Kleinig, TJ, Sahlein, D, Elijovich, L, Tekle, W, Samaniego, EA, Maali, L, Abdulrazzak, MA, Psychogios, MN, Shuaib, A, Pujara, DK, Shaker, F, Johns, H, Sharma, G, Yogendrakumar, V, Ng, FC, Rahbar, MH, Cai, C, Lavori, P, Hamilton, S, Nguyen, T, Fifi, JT, Davis, S, Wechsler, L, Pereira, VM, Lansberg, MG, Hill, MD, Grotta, JC, Ribo, M, Campbell, BC & Albers, GW 2023, 'Trial of endovascular thrombectomy for large ischemic strokes', New England Journal of Medicine, vol. 388, no. 14, pp. 1259-1271. https://doi.org/10.1056/NEJMoa2214403

TY - JOUR

T1 - Trial of endovascular thrombectomy for large ischemic strokes

AU - Sarraj, A.

AU - Hassan, A. E.

AU - Abraham, M. G.

AU - Ortega-Gutierrez, S.

AU - Kasner, S. E.

AU - Hussain, M. S.

AU - Chen, M.

AU - Blackburn, S.

AU - Sitton, C. W.

AU - Churilov, L.

AU - Sundararajan, S.

AU - Hu, Y. C.

AU - Herial, N. A.

AU - Jabbour, P.

AU - Gibson, D.

AU - Wallace, A. N.

AU - Arenillas, J .F.

AU - Tsai, J. P.

AU - Budzik, R. F.

AU - Hicks, W. J.

AU - Kozak, O.

AU - Yan, B.

AU - Cordato, D. J.

AU - Manning, N. W.

AU - Parsons, M. W.

AU - Hanel, R. A.

AU - Aghaebrahim, A. N.

AU - Wu, T. Y.

AU - Cardona-Portela, P.

AU - Perez de la Ossa, N.

AU - Schaafsma, J. D.

AU - Blasco, J.

AU - Sangha, N.

AU - Warach, S.

AU - Gandhi, C. D.

AU - Kleinig, T. J.

AU - Sahlein, D.

AU - Elijovich, L.

AU - Tekle, W.

AU - Samaniego, E. A.

AU - Maali, L.

AU - Abdulrazzak, M. A.

AU - Psychogios, M. N.

AU - Shuaib, A.

AU - Pujara, D. K.

AU - Shaker, F.

AU - Johns, H.

AU - Sharma, G.

AU - Yogendrakumar, V.

AU - Ng, F. C.

AU - Rahbar, M. H.

AU - Cai, C.

AU - Lavori, P.

AU - Hamilton, S.

AU - Nguyen, T.

AU - Fifi, J. T.

AU - Davis, S.

AU - Wechsler, L.

AU - Pereira, V. M.

AU - Lansberg, M. G.

AU - Hill, M. D.

AU - Grotta, J. C.

AU - Ribo, M.

AU - Campbell, B. C.

AU - Albers, G. W.

PY - 2023

Y1 - 2023

N2 - Abstract Background Trials of the efficacy and safety of endovascular thrombectomy in patients with large ischemic strokes have been carried out in limited populations. Methods We performed a prospective, randomized, open-label, adaptive, international trial involving patients with stroke due to occlusion of the internal carotid artery or the first segment of the middle cerebral artery to assess endovascular thrombectomy within 24 hours after onset. Patients had a large ischemic-core volume, defined as an Alberta Stroke Program Early Computed Tomography Score of 3 to 5 (range, 0 to 10, with lower scores indicating larger infarction) or a core volume of at least 50 ml on computed tomography perfusion or diffusion-weighted magnetic resonance imaging. Patients were assigned in a 1:1 ratio to endovascular thrombectomy plus medical care or to medical care alone. The primary outcome was the modified Rankin scale score at 90 days (range, 0 to 6, with higher scores indicating greater disability). Functional independence was a secondary outcome. Results The trial was stopped early for efficacy; 178 patients had been assigned to the thrombectomy group and 174 to the medical-care group. The generalized odds ratio for a shift in the distribution of modified Rankin scale scores toward better outcomes in favor of thrombectomy was 1.51 (95% confidence interval [CI], 1.20 to 1.89; P<0.001). A total of 20% of the patients in the thrombectomy group and 7% in the medical-care group had functional independence (relative risk, 2.97; 95% CI, 1.60 to 5.51). Mortality was similar in the two groups. In the thrombectomy group, arterial access-site complications occurred in 5 patients, dissection in 10, cerebral-vessel perforation in 7, and transient vasospasm in 11. Symptomatic intracranial hemorrhage occurred in 1 patient in the thrombectomy group and in 2 in the medical-care group. Conclusions Among patients with large ischemic strokes, endovascular thrombectomy resulted in better functional outcomes than medical care but was associated with vascular complications. Cerebral hemorrhages were infrequent in both groups. (Funded by Stryker Neurovascular; SELECT2 ClinicalTrials.gov number, NCT03876457.)

AB - Abstract Background Trials of the efficacy and safety of endovascular thrombectomy in patients with large ischemic strokes have been carried out in limited populations. Methods We performed a prospective, randomized, open-label, adaptive, international trial involving patients with stroke due to occlusion of the internal carotid artery or the first segment of the middle cerebral artery to assess endovascular thrombectomy within 24 hours after onset. Patients had a large ischemic-core volume, defined as an Alberta Stroke Program Early Computed Tomography Score of 3 to 5 (range, 0 to 10, with lower scores indicating larger infarction) or a core volume of at least 50 ml on computed tomography perfusion or diffusion-weighted magnetic resonance imaging. Patients were assigned in a 1:1 ratio to endovascular thrombectomy plus medical care or to medical care alone. The primary outcome was the modified Rankin scale score at 90 days (range, 0 to 6, with higher scores indicating greater disability). Functional independence was a secondary outcome. Results The trial was stopped early for efficacy; 178 patients had been assigned to the thrombectomy group and 174 to the medical-care group. The generalized odds ratio for a shift in the distribution of modified Rankin scale scores toward better outcomes in favor of thrombectomy was 1.51 (95% confidence interval [CI], 1.20 to 1.89; P<0.001). A total of 20% of the patients in the thrombectomy group and 7% in the medical-care group had functional independence (relative risk, 2.97; 95% CI, 1.60 to 5.51). Mortality was similar in the two groups. In the thrombectomy group, arterial access-site complications occurred in 5 patients, dissection in 10, cerebral-vessel perforation in 7, and transient vasospasm in 11. Symptomatic intracranial hemorrhage occurred in 1 patient in the thrombectomy group and in 2 in the medical-care group. Conclusions Among patients with large ischemic strokes, endovascular thrombectomy resulted in better functional outcomes than medical care but was associated with vascular complications. Cerebral hemorrhages were infrequent in both groups. (Funded by Stryker Neurovascular; SELECT2 ClinicalTrials.gov number, NCT03876457.)

UR - https://hdl.handle.net/1959.7/uws:73490

U2 - 10.1056/NEJMoa2214403

DO - 10.1056/NEJMoa2214403

M3 - Article

SN - 0028-4793

VL - 388

SP - 1259

EP - 1271

JO - New England Journal of Medicine

JF - New England Journal of Medicine

IS - 14

ER -

Trial of endovascular thrombectomy for large ischemic strokes

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