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1. Clinical relevance of intracranial hemorrhage after thrombectomy versus medical management for large core infarct: a secondary analysis of the SELECT2 randomized trial

Author

Chen, Michael, primary, Joshi, Krishna C, additional, Kolb, Bradley, additional, Sitton, Clark W, additional, Pujara, Deep Kiritbhai, additional, Abraham, Michael G, additional, Ortega-Gutierrez, Santiago, additional, Kasner, Scott E, additional, Hussain, Shazam M, additional, Churilov, Leonid, additional, Blackburn, Spiros, additional, Sundararajan, Sophia, additional, Hu, Yin C, additional, Herial, Nabeel, additional, Arenillas, Juan F, additional, Tsai, Jenny P, additional, Budzik, Ronald F, additional, Hicks, William, additional, Kozak, Osman, additional, Yan, Bernard, additional, Cordato, Dennis, additional, Manning, Nathan W, additional, Parsons, Mark, additional, Hanel, Ricardo A, additional, Aghaebrahim, Amin, additional, Wu, Teddy, additional, Cardona Portela, Pere, additional, Gandhi, Chirag D, additional, Al-Mufti, Fawaz, additional, Perez de la Ossa, Natalia, additional, Schaafsma, Joanna, additional, Blasco, Jordi, additional, Sangha, Navdeep, additional, Warach, Steven, additional, Kleinig, Timothy J, additional, Johns, Hannah, additional, Shaker, Faris, additional, Abdulrazzak, Mohammad A, additional, Ray, Abhishek, additional, Sunshine, Jeffery, additional, Opaskar, Amanda, additional, Duncan, Kelsey R, additional, Xiong, Wei, additional, Al-Shaibi, Faisal K, additional, Samaniego, Edgar A, additional, Nguyen, Thanh N, additional, Fifi, Johanna T, additional, Tjoumakaris, Stavropoula I, additional, Jabbour, Pascal, additional, Mendes Pereira, Vitor, additional, Lansberg, Maarten G, additional, Sila, Cathy, additional, Bambakidis, Nicholas C, additional, Davis, Stephen, additional, Wechsler, Lawrence, additional, Albers, Gregory W, additional, Grotta, James C, additional, Ribo, Marc, additional, Hassan, Ameer E, additional, Campbell, Bruce, additional, Hill, Michael D, additional, and Sarraj, Amrou, additional

Published
2024
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5. Endovascular Thrombectomy Treatment Effect in Direct vs Transferred Patients With Large Ischemic Strokes: A Prespecified Analysis of the SELECT2 Trial

Author

Sarraj, Amrou, Hill, Michael D., Hussain, M. Shazam, Abraham, Michael G., Ortega-Gutierrez, Santiago, Chen, Michael, Kasner, Scott E., Churilov, Leonid, Pujara, Deep K., Johns, Hannah, Blackburn, Spiros, Sundararajan, Sophia, Hu, Yin C., Herial, Nabeel A., Budzik, Ronald F., Hicks, William J., Arenillas, Juan F., Tsai, Jenny P., Kozak, Osman, Cordato, Dennis J., Hanel, Ricardo A., Wu, Teddy Y., Portela, Pere Cardona, Gandhi, Chirag D., Al-Mufti, Fawaz, Maali, Laith, Gibson, Daniel, Pérez de la Ossa, Natalia, Schaafsma, Joanna D., Blasco, Jordi, Sangha, Navdeep, Warach, Steven, Kleinig, Timothy J., Shaker, Faris, Sitton, Clark W., Nguyen, Thanh, Fifi, Johanna T., Jabbour, Pascal, Furlan, Anthony, Lansberg, Maarten G., Tsivgoulis, Georgios, Sila, Cathy, Bambakidis, Nicholas, Davis, Stephen, Wechsler, Lawrence, Albers, Greg W., Grotta, James C., Ribo, Marc, Campbell, Bruce C., Hassan, Ameer E., Vora, Nirav, Manning, Nathan W., Cheung, Andrew, Aghaebrahim, Amin N., Paipa Merchán, Andres J., Sahlein, Daniel, Requena Ruiz, Manuel, Elijovich, Lucas, Arthur, Adam, Al-Shaibi, Faisal, Samaniego, Edgar A., Duncan, Kelsey R., Opaskar, Amanda, Ray, Abhishek, Xiong, Wei, Sunshine, Jeffery, DeGeorgia, Michael, Tjoumakaris, Stavropoula, and Mendes Pereira, Vitor

Abstract

IMPORTANCE: Patients with large ischemic core stroke have poor clinical outcomes and are frequently not considered for interfacility transfer for endovascular thrombectomy (EVT). OBJECTIVE: To assess EVT treatment effects in transferred vs directly presenting patients and to evaluate the association between transfer times and neuroimaging changes with EVT clinical outcomes. DESIGN, SETTING, AND PARTICIPANTS: This prespecified secondary analysis of the SELECT2 trial, which evaluated EVT vs medical management (MM) in patients with large ischemic stroke, evaluated adults aged 18 to 85 years with acute ischemic stroke due to occlusion of the internal carotid or middle cerebral artery (M1 segment) as well as an Alberta Stroke Program Early CT Score (ASPECTS) of 3 to 5, core of 50 mL or greater on imaging, or both. Patients were enrolled between October 2019 and September 2022 from 31 EVT-capable centers in the US, Canada, Europe, Australia, and New Zealand. Data were analyzed from August 2023 to January 2024. INTERVENTIONS: EVT vs MM. MAIN OUTCOMES AND MEASURES: Functional outcome, defined as modified Rankin Scale (mRS) score at 90 days with blinded adjudication. RESULTS: A total of 958 patients were screened and 606 patients were excluded. Of 352 enrolled patients, 145 (41.2%) were female, and the median (IQR) age was 66.5 (58-75) years. A total of 211 patients (59.9%) were transfers, while 141 (40.1%) presented directly. The median (IQR) transfer time was 178 (136-230) minutes. The median (IQR) ASPECTS decreased from the referring hospital (5 [4-7]) to an EVT-capable center (4 [3-5]). Thrombectomy treatment effect was observed in both directly presenting patients (adjusted generalized odds ratio [OR], 2.01; 95% CI, 1.42-2.86) and transferred patients (adjusted generalized OR, 1.50; 95% CI, 1.11-2.03) without heterogeneity (P for interaction = .14). Treatment effect point estimates favored EVT among 82 transferred patients with a referral hospital ASPECTS of 5 or less (44 received EVT; adjusted generalized OR, 1.52; 95% CI, 0.89-2.58). ASPECTS loss was associated with numerically worse EVT outcomes (adjusted generalized OR per 1-ASPECTS point loss, 0.89; 95% CI, 0.77-1.02). EVT treatment effect estimates were lower in patients with transfer times of 3 hours or more (adjusted generalized OR, 1.15; 95% CI, 0.73-1.80). CONCLUSIONS AND RELEVANCE: Both directly presenting and transferred patients with large ischemic stroke in the SELECT2 trial benefited from EVT, including those with low ASPECTS at referring hospitals. However, the association of EVT with better functional outcomes was numerically better in patients presenting directly to EVT-capable centers. Prolonged transfer times and evolution of ischemic change were associated with worse EVT outcomes. These findings emphasize the need for rapid identification of patients suitable for transfer and expedited transport. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03876457

Published
2024
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6. Abstract WMP91: The Penumbra Salvage Index (PSI) As A Novel Measure Of Successful Reperfusion

Author

Al-Shaibi, Faisal, primary, Pujara, Deep, additional, Saidi, Yazid, additional, Hassan, Ameer E, additional, Abraham, Michael G, additional, sitton, clark, additional, Shaker, Faris, additional, Duncan, Kelsey R, additional, Chugh, Arunit S, additional, Sundararajan, Sophia, additional, Hu, Yin, additional, Abhishek, Ray, additional, Sila, Cathy A, additional, Bambakidis, Nicholas C, additional, Albers, Gregory W, additional, Campbell, Bruce, additional, and Sarraj, Amrou, additional

Published
2023
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7. Abstract WP56: Improvement In Motor And Language Domains Mediates Most Of The Effect Of 24h NIHSS Improvement On Functional Independence

Author

Pujara, Deep, primary, Churilov, Leonid, additional, Hassan, Ameer E, additional, Abraham, Michael G, additional, sitton, clark, additional, Duncan, Kelsey R, additional, Al-Shaibi, Faisal, additional, Shaker, Faris, additional, Sundararajan, Sophia, additional, Sila, Cathy A, additional, Albers, Gregory W, additional, Campbell, Bruce, additional, and Sarraj, Amrou, additional

Published
2023
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8. Association of Endovascular Thrombectomy vs Medical Management With Functional and Safety Outcomes in Patients Treated Beyond 24 Hours of Last Known Well

Author

Sarraj, Amrou, primary, Kleinig, Timothy J., additional, Hassan, Ameer E., additional, Portela, Pere Cardona, additional, Ortega-Gutierrez, Santiago, additional, Abraham, Michael G., additional, Manning, Nathan W., additional, Siegler, James E., additional, Goyal, Nitin, additional, Maali, Laith, additional, Blackburn, Spiros, additional, Wu, Teddy Y., additional, Blasco, Jordi, additional, Renú, Arturu, additional, Sangha, Navdeep S., additional, Arenillas, Juan F., additional, McCullough-Hicks, Margy E., additional, Wallace, Adam, additional, Gibson, Daniel, additional, Pujara, Deep K., additional, Shaker, Faris, additional, de Lera Alfonso, Mercedes, additional, Olivé-Gadea, Marta, additional, Farooqui, Mudassir, additional, Vivanco Suarez, Juan S., additional, Iezzi, Zachary, additional, Khalife, Jane, additional, Lechtenberg, Colleen G., additional, Qadri, Syed K., additional, Moussa, Rami B., additional, Abdulrazzak, Mohammad A., additional, Almaghrabi, Tareq S., additional, Mir, Osman, additional, Beharry, James, additional, Krishnaiah, Balaji, additional, Miller, Megan, additional, Khalil, Najwa, additional, Sharma, Gagan J., additional, Katsanos, Aristeidis H., additional, Fadhil, Ali, additional, Duncan, Kelsey R., additional, Hu, Yin, additional, Martin-Schild, Sheryl B., additional, Tsivgoulis, Georgios K., additional, Cordato, Dennis, additional, Furlan, Anthony, additional, Churilov, Leonid, additional, Mitchell, Peter J., additional, Arthur, Adam S., additional, Parsons, Mark W., additional, Grotta, James C., additional, Sitton, Clark W., additional, Ribo, Marc, additional, Albers, Gregory W., additional, and Campbell, Bruce C. V., additional

Published
2022
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10. Abstract 36: Endovascular Thrombectomy Beyond 24 Hours From Last Known Well: A Pooled Multicenter International Cohort

Author

Sarraj, Amrou, primary, Hassan, Ameer E, additional, Abraham, Michael G, additional, Cardona Portela, Pere, additional, Manning, Nathan W, additional, Cordato, Dennis, additional, Kleinig, Timothy J, additional, Goyal, Nitin, additional, Blackburn, Spiros, additional, McCullough-Hicks, Margy E, additional, Ribo, Marc, additional, Wu, Teddy Y, additional, Blasco, Jordi, additional, Sangha, Navdeep, additional, Arenillas, Juan F, additional, Wallace, Adam, additional, Pujara, Deep K, additional, Shaker, Faris, additional, de Lera Alfonso, Mercedes, additional, Renu, Arturo, additional, Olivé Gadea, Marta, additional, Gibson, Daniel, additional, Lechtenberg, Colleen G, additional, Maali, Laith N, additional, Abdulrazzak, Mohammad A, additional, Almaghrabi, Tareq S, additional, Beharry, James, additional, Krishnaiah, Balaji, additional, Miller, Megan, additional, Khalil, Najwa, additional, Sharma, Gagan J, additional, Katsanos, Aristeidis H, additional, Fadhil, Ali, additional, Duncan, Kelsey R, additional, Hu, Yin, additional, sitton, clark W, additional, Martin-schild, Sheryl B, additional, Tsivgoulis, Georgios K, additional, Mitchell, Peter J, additional, Arthur, Adam S, additional, Parsons, Mark, additional, Grotta, James C, additional, Campbell, Bruce C, additional, and Albers, Gregory W, additional

Published
2022
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11. Association of Endovascular Thrombectomy vs Medical Management With Functional and Safety Outcomes in Patients Treated Beyond 24 Hours of Last Known Well: The SELECT Late Study

Author

Sarraj, Amrou, Kleinig, Timothy J., Hassan, Ameer E., Portela, Pere Cardona, Ortega-Gutierrez, Santiago, Abraham, Michael G., Manning, Nathan W., Siegler, James E., Goyal, Nitin, Maali, Laith, Blackburn, Spiros, Wu, Teddy Y., Blasco, Jordi, Renú, Arturu, Sangha, Navdeep S., Arenillas, Juan F., McCullough-Hicks, Margy E., Wallace, Adam, Gibson, Daniel, Pujara, Deep K., Shaker, Faris, de Lera Alfonso, Mercedes, Olivé-Gadea, Marta, Farooqui, Mudassir, Vivanco Suarez, Juan S., Iezzi, Zachary, Khalife, Jane, Lechtenberg, Colleen G., Qadri, Syed K., Moussa, Rami B., Abdulrazzak, Mohammad A., Almaghrabi, Tareq S., Mir, Osman, Beharry, James, Krishnaiah, Balaji, Miller, Megan, Khalil, Najwa, Sharma, Gagan J., Katsanos, Aristeidis H., Fadhil, Ali, Duncan, Kelsey R., Hu, Yin, Martin-Schild, Sheryl B., Tsivgoulis, Georgios K., Cordato, Dennis, Furlan, Anthony, Churilov, Leonid, Mitchell, Peter J., Arthur, Adam S., Parsons, Mark W., Grotta, James C., Sitton, Clark W., Ribo, Marc, Albers, Gregory W., and Campbell, Bruce C. V.

Abstract

IMPORTANCE: The role of endovascular thrombectomy is uncertain for patients presenting beyond 24 hours of the time they were last known well. OBJECTIVE: To evaluate functional and safety outcomes for endovascular thrombectomy (EVT) vs medical management in patients with large-vessel occlusion beyond 24 hours of last known well. DESIGN, SETTING, AND PARTICIPANTS: This retrospective observational cohort study enrolled patients between July 2012 and December 2021 at 17 centers across the United States, Spain, Australia, and New Zealand. Eligible patients had occlusions in the internal carotid artery or middle cerebral artery (M1 or M2 segment) and were treated with EVT or medical management beyond 24 hours of last known well. INTERVENTIONS: Endovascular thrombectomy or medical management (control). MAIN OUTCOMES AND MEASURES: Primary outcome was functional independence (modified Rankin Scale score 0-2). Mortality and symptomatic intracranial hemorrhage (sICH) were safety outcomes. Propensity score (PS)–weighted multivariable logistic regression analyses were adjusted for prespecified clinical characteristics, perfusion parameters, and/or Alberta Stroke Program Early CT Score (ASPECTS) and were repeated in subsequent 1:1 PS-matched cohorts. RESULTS: Of 301 patients (median [IQR] age, 69 years [59-81]; 149 female), 185 patients (61%) received EVT and 116 (39%) received medical management. In adjusted analyses, EVT was associated with better functional independence (38% vs control, 10%; inverse probability treatment weighting adjusted odds ratio [IPTW aOR], 4.56; 95% CI, 2.28-9.09; P < .001) despite increased odds of sICH (10.1% for EVT vs 1.7% for control; IPTW aOR, 10.65; 95% CI, 2.19-51.69; P = .003). This association persisted after PS-based matching on (1) clinical characteristics and ASPECTS (EVT, 35%, vs control, 19%; aOR, 3.14; 95% CI, 1.02-9.72; P = .047); (2) clinical characteristics and perfusion parameters (EVT, 35%, vs control, 17%; aOR, 4.17; 95% CI, 1.15-15.17; P = .03); and (3) clinical characteristics, ASPECTS, and perfusion parameters (EVT, 45%, vs control, 21%; aOR, 4.39; 95% CI, 1.04-18.53; P = .04). Patients receiving EVT had lower odds of mortality (26%) compared with those in the control group (41%; IPTW aOR, 0.49; 95% CI, 0.27-0.89; P = .02). CONCLUSIONS AND RELEVANCE: In this study of treatment beyond 24 hours of last known well, EVT was associated with higher odds of functional independence compared with medical management, with consistent results obtained in PS-matched subpopulations and patients with presence of mismatch, despite increased odds of sICH. Our findings support EVT feasibility in selected patients beyond 24 hours. Prospective studies are warranted for confirmation.

Published
2023
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14. Anticoagulation Use and Endovascular Thrombectomy in Patients with Large Core Stroke: A Secondary Analysis of the SELECT2 Trial.

Author

Pujara DK, Hussain MS, Abraham MG, Ortega-Gutierrez S, Chen M, Kasner SE, Churilov L, Sitton CW, Blackburn S, Sundararajan S, Hu YC, Herial NA, Budzik RF, Hicks WJ, Arenillas JF, Tsai JP, Kozak O, Cordato DJ, Manning NW, Hanel RA, Aghaebrahim AN, Wu TY, Cardona Portela P, Pérez de la Ossa N, Schaafsma JD, Blasco J, Sangha N, Warach S, Gandhi CD, Al-Mufti F, Kleinig TJ, Al-Shaibi F, Duncan KR, Shaker F, Johns H, Xiong W, DeGeorgia M, Opaskar A, Sunshine J, Ray A, Jabbour P, Bambakidis N, Sila C, Nguyen TN, Grotta JC, Hassan AE, Ribo M, Hill MD, Campbell BC, and Sarraj A

Subjects
Humans, Aged, Female, Male, Middle Aged, Aged, 80 and over, Ischemic Stroke surgery, Stroke surgery, Treatment Outcome, Thrombectomy methods, Endovascular Procedures methods, Anticoagulants therapeutic use, Anticoagulants administration & dosage, Anticoagulants adverse effects
Abstract

Endovascular thrombectomy (EVT) safety and efficacy in patients with large core infarcts receiving oral anticoagulants (OAC) are unknown. In the SELECT2 trial (NCT03876457), 29 of 180 (16%; vitamin K antagonists 15, direct OACs 14) EVT, and 18 of 172 (10%; vitamin K antagonists 3, direct OACs 15) medical management (MM) patients reported OAC use at baseline. EVT was not associated with better clinical outcomes in the OAC group (EVT 6 [4-6] vs MM 5 [4-6], adjusted generalized odds ratio 0.89 [0.53-1.50]), but demonstrated significantly better outcomes in patients without OAC (EVT 4 [3-6] vs MM 5 [4-6], adjusted generalized odds ratio 1.87 [1.45-2.40], p = 0.02). The OAC group had higher comorbidities, including atrial fibrillation (70% vs 17%), congestive heart failure (28% vs 10%), and hypertension (87% vs 72%), suggesting increased frailty. However, the results were consistent after adjustment for these comorbidities, and was similar regardless of the type of OACs used. Whereas any hemorrhage rates were higher in the OAC group receiving EVT (86% in OAC vs 70% in no OAC), no parenchymal hemorrhage or symptomatic intracranial hemorrhage were observed with OAC use in both the EVT and MM arms. Although we did not find evidence that the effect was due to excess hemorrhage or confounded by underlying cardiac disease or older age, OAC use alone should not exclude patients from receiving EVT. Baseline comorbidities and ischemic injury extent should be considered while making individualized treatment decisions. ANN NEUROL 2024;96:887-894., (© 2024 American Neurological Association.)

Published
2024
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15. Endovascular Thrombectomy for Large Ischemic Stroke Across Ischemic Injury and Penumbra Profiles.

Author

Sarraj A, Hassan AE, Abraham MG, Ortega-Gutierrez S, Kasner SE, Hussain MS, Chen M, Churilov L, Johns H, Sitton CW, Yogendrakumar V, Ng FC, Pujara DK, Blackburn S, Sundararajan S, Hu YC, Herial NA, Arenillas JF, Tsai JP, Budzik RF, Hicks WJ, Kozak O, Yan B, Cordato DJ, Manning NW, Parsons MW, Cheung A, Hanel RA, Aghaebrahim AN, Wu TY, Portela PC, Gandhi CD, Al-Mufti F, Pérez de la Ossa N, Schaafsma JD, Blasco J, Sangha N, Warach S, Kleinig TJ, Shaker F, Al Shaibi F, Toth G, Abdulrazzak MA, Sharma G, Ray A, Sunshine J, Opaskar A, Duncan KR, Xiong W, Samaniego EA, Maali L, Lechtenberg CG, Renú A, Vora N, Nguyen T, Fifi JT, Tjoumakaris SI, Jabbour P, Tsivgoulis G, Pereira VM, Lansberg MG, DeGeorgia M, Sila CA, Bambakidis N, Hill MD, Davis SM, Wechsler L, Grotta JC, Ribo M, Albers GW, and Campbell BC

Subjects
Adult, Humans, Female, Aged, Male, Thrombectomy adverse effects, Thrombectomy methods, Brain diagnostic imaging, Stroke diagnostic imaging, Stroke surgery, Ischemic Stroke diagnostic imaging, Ischemic Stroke surgery, Brain Ischemia diagnostic imaging, Brain Ischemia surgery
Abstract

Importance: Whether endovascular thrombectomy (EVT) efficacy for patients with acute ischemic stroke and large cores varies depending on the extent of ischemic injury is uncertain., Objective: To describe the relationship between imaging estimates of irreversibly injured brain (core) and at-risk regions (mismatch) and clinical outcomes and EVT treatment effect., Design, Setting, and Participants: An exploratory analysis of the SELECT2 trial, which randomized 352 adults (18-85 years) with acute ischemic stroke due to occlusion of the internal carotid or middle cerebral artery (M1 segment) and large ischemic core to EVT vs medical management (MM), across 31 global centers between October 2019 and September 2022., Intervention: EVT vs MM., Main Outcomes and Measures: Primary outcome was functional outcome-90-day mRS score (0, no symptoms, to 6, death) assessed by adjusted generalized OR (aGenOR; values >1 represent more favorable outcomes). Benefit of EVT vs MM was assessed across levels of ischemic injury defined by noncontrast CT using ASPECTS score and by the volume of brain with severely reduced blood flow on CT perfusion or restricted diffusion on MRI., Results: Among 352 patients randomized, 336 were analyzed (median age, 67 years; 139 [41.4%] female); of these, 168 (50%) were randomized to EVT, and 2 additional crossover MM patients received EVT. In an ordinal analysis of mRS at 90 days, EVT improved functional outcomes compared with MM within ASPECTS categories of 3 (aGenOR, 1.71 [95% CI, 1.04-2.81]), 4 (aGenOR, 2.01 [95% CI, 1.19-3.40]), and 5 (aGenOR, 1.85 [95% CI, 1.22-2.79]). Across strata for CT perfusion/MRI ischemic core volumes, aGenOR for EVT vs MM was 1.63 (95% CI, 1.23-2.16) for volumes ≥70 mL, 1.41 (95% CI, 0.99-2.02) for ≥100 mL, and 1.47 (95% CI, 0.84-2.56) for ≥150 mL. In the EVT group, outcomes worsened as ASPECTS decreased (aGenOR, 0.91 [95% CI, 0.82-1.00] per 1-point decrease) and as CT perfusion/MRI ischemic core volume increased (aGenOR, 0.92 [95% CI, 0.89-0.95] per 10-mL increase). No heterogeneity of EVT treatment effect was observed with or without mismatch, although few patients without mismatch were enrolled., Conclusion and Relevance: In this exploratory analysis of a randomized clinical trial of patients with extensive ischemic stroke, EVT improved clinical outcomes across a wide spectrum of infarct volumes, although enrollment of patients with minimal penumbra volume was low. In EVT-treated patients, clinical outcomes worsened as presenting ischemic injury estimates increased., Trial Registration: ClinicalTrials.gov Identifier: NCT03876457.

Published
2024
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