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. 2024 Feb 8;81(4):327-335.
doi: 10.1001/jamaneurol.2024.0206. Online ahead of print.

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

Amrou Sarraj  1 , Michael D Hill  2 , M Shazam Hussain  3 , Michael G Abraham  4 , Santiago Ortega-Gutierrez  5 , Michael Chen  6 , Scott E Kasner  7 , Leonid Churilov  8 , Deep K Pujara  1 , Hannah Johns  8 , Spiros Blackburn  9 , Sophia Sundararajan  1 , Yin C Hu  10 , Nabeel A Herial  11 , Ronald F Budzik  12 , William J Hicks  13 , Juan F Arenillas  14 , Jenny P Tsai  15 , Osman Kozak  16 , Dennis J Cordato  17 , Ricardo A Hanel  18 , Teddy Y Wu  19 , Pere Cardona Portela  20 , Chirag D Gandhi  21 , Fawaz Al-Mufti  21 , Laith Maali  4 , Daniel Gibson  22 , Natalia Pérez de la Ossa  23 , Joanna D Schaafsma  24 , Jordi Blasco  25 , Navdeep Sangha  26 , Steven Warach  27 , Timothy J Kleinig  28 , Faris Shaker  9 , Clark W Sitton  29 , Thanh Nguyen  30 , Johanna T Fifi  31 , Pascal Jabbour  11 , Anthony Furlan  1 , Maarten G Lansberg  32 , Georgios Tsivgoulis  33 , Cathy Sila  1 , Nicholas Bambakidis  10 , Stephen Davis  34 , Lawrence Wechsler  35 , Greg W Albers  32 , James C Grotta  36 , Marc Ribo  37 , Bruce C Campbell  38 , Ameer E Hassan  39 ; SELECT2 Investigators; SELECT2 Collaborators; Nirav Vora  12 , Nathan W Manning  40 , Andrew Cheung  40 , Amin N Aghaebrahim  18 , Andres J Paipa Merchán  41 , Daniel Sahlein  42 , Manuel Requena Ruiz  43 , Lucas Elijovich  44 , Adam Arthur  44 , Faisal Al-Shaibi  1 , Edgar A Samaniego  45 , Kelsey R Duncan  1 , Amanda Opaskar  1 , Abhishek Ray  10 , Wei Xiong  1 , Jeffery Sunshine  10 , Michael DeGeorgia  1 , Stavropoula Tjoumakaris  11 , Vitor Mendes Pereira  46 ; SELECT2 Collaborators
Collaborators, Affiliations

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

Amrou Sarraj et al. JAMA Neurol. .

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.

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Conflict of interest statement

Conflict of Interest Disclosures: Dr Sarraj reported grants from Stryker Neurovascular during the conduct of the study. Dr Hill reported grants from Medtronic and personal fees from Microvention outside the submitted work. Dr Hussain reported grants from Medtronic Core Lab as well as personal fees from Stryker Neurovascular, Rapid Medical, and Cerenovus outside the submitted work. Dr Abraham consulted for Stryker Neurovascular and Q’Apel outside the submitted work. Dr Ortega-Gutierrez reported grants from Stryker Neurovascular, National Institute of Neurological Disorders and Stroke, and MicroVention as well as personal fees from Medtronic and Stryker Neurovascular outside the submitted work. Dr Kasner reported grants from Stryker during the conduct of the study; grants from Bayer, Bristol Myers Squibb, Diamedica, and Genentech as well as personal fees from NovoNordisk, Artivion, and UpToDate outside the submitted work. Dr Herial reported honorarium from Medtronic outside the submitted work. Dr Budzik reported grants from Stryker Neurovascular during the conduct of the study. Dr Arenillas reported grants from the Spanish Ministry of Science, Spanish Ministry of Science, European Commission, Castilla-Leon Department of Health, University Valladolid, and AstraZeneca as well as personal fees from AstraZeneca, Medtronic, Medtronic, Amgen, BMS-Pfizer, Daiichi Sankyo, and University Valladolid outside the submitted work. Dr Tsai reported personal fees from Medtronic, MicroVention, Cerenovus, Q’Apel, and Imperative Care outside the submitted work. Dr Manning reported personal fees from Medtronic, Stryker, and MicroVention outside the submitted work. Dr Cheung reported personal fees from Medtronic outside the submitted work. Dr Hanel reported grants from the National Institutes of Health, Interline Endowment, MicroVention, Stryker, and CNX; personal fees from Medtronic, Stryker, Cerenovous, MicroVention, Balt, Phenox, Rapid Medical, Q’Apel, MIVI Neuroscience, eLum, Three Rivers Medical, Shape Medical, and Corindus; and holds stock in InNeuroCo, Cerebrotech, eLum, Endostream, Three Rivers Medical, Scientia, RisT, BlinkTBI, Corindus, and NTI outside the submitted work. Dr Gibson serves on the clinical advisory board for iSchemaView outside the submitted work. Dr Sahlein reported grants from MicroVention; personal fees from Medtronic and Kaneka; and holds stock in Scientia, Vasorum, and Emboa outside the submitted work; and has a patent for TRAP pending. Dr Warach reported grants from the University Hospital Cleveland and The University of Texas Health Science Center at Houston during the conduct of the study as well as personal fees from Genentech outside the submitted work. Dr Arthur reported personal fees from Balt, Johnson and Johnson, Medtronic, Microvention, Penumbra, Perfuze, Scientia, Siemens, and Stryker and holds stock in Bendit, Cerebrotech, Magneto, and Vastrax outside the submitted work. Dr Sitton reported grants from Stryker during the conduct of the study. Dr Nguyen serves on the advisory board of Idorsia and Brainomix and is an Associate Editor of Stroke for the American Stroke Association outside the submitted work. Dr Fifi reported personal fees from University of Houston during the conduct of the study; personal fees from Cerenovus, MicroVention, Stryker, MIVI Neuroscience, and Medtronic; and holds stock in Imperative Care outside the submitted work. Dr Tjoumakaris reported personal fees from MicroVention outside the submitted work. Dr Mendes Pereira reported personal fees from Stryker outside the submitted work. Dr Sila reported grants from University Hospitals during the conduct of the study. Dr Bambakidis reported grants from Idorsia outside the submitted work. Dr Davis reported personal fees from Boehringer Ingelheim and Medtronic outside the submitted work. Dr Wechsler reported personal fees from Astellas Pharma, Athersys, Silk Road Medical, and Forest Devices outside the submitted work. Dr Albers reported personal fees from iSchemaView and Genentech outside the submitted work. Dr Hassan reported personal fees from Medtronic, MicroVention, Stryker, Penumbra, Cerenovus, Genentech, GE Healthcare, Scientia, Balt, Viz.ai, Insera Therapeutics, Proximie, NeuroVasc, NovaSignal, Vesalio, Rapid Medical, Imperative Care, Galaxy Therapeutics, Route 92, and Perfuze outside the submitted work. No other disclosures were reported.

Figures

Figure 1.
Figure 1.. Flow Diagram of the Study Participants
ASPECTS indicates Alberta Stroke Program Early CT Score; EVT, endovascular thrombectomy; LKW, last known well; MM, medical management; mRS, modified Rankin Scale; tPA, tissue plasminogen activator.
Figure 2.
Figure 2.. Forest Plot of the Association of Endovascular Thrombectomy (EVT) With Distribution of 90-Day Modified Rankin Scale Scores in Patients Directly Presenting and Transferring to an EVT-Capable Center
ASPECTS, Alberta Stroke Program Early CT Score; CT, computed tomography; ICA, internal carotid artery; LKW, last known well; MCA, middle cerebral artery; MM, medical management; NA, not applicable; NIHSS, National Institutes of Health Stroke Scale; OR, odds ratio.
Figure 3.
Figure 3.. Predicted Marginal Probabilities of Independent Ambulation (Modified Rankin Scale [mRS] Score of 0 to 3) by Transfer Time in Those Receiving Endovascular Thrombectomy and Medical Management
As transfer time increased, the predicted probability of independent ambulation decreased in both arms, but treatment effects were largely preserved. Shaded areas indicate 95% CIs.
Figure 4.
Figure 4.. Predicted Marginal Probabilities of Independent Ambulation (Modified Rankin Scale [mRS] Score of 0 to 3) by Loss of Alberta Stroke Program Early CT Score (ASPECTS) Points During Transfers in Those Receiving Endovascular Thrombectomy and Medical Management
As ASPECTS loss increased, the predicted probability of independent ambulation decreased in arms, but treatment effects were largely preserved. Shaded areas indicate 95% CIs.
See this image and copyright information in PMC

References

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