TY - JOUR
T1 - Endovascular Thrombectomy Versus Medical Management in Isolated M2 Occlusions
T2 - Pooled Patient-Level Analysis from the EXTEND-IA Trials, INSPIRE, and SELECT Studies
AU - Sarraj, Amrou
AU - Parsons, Mark
AU - Bivard, Andrew
AU - Hassan, Ameer E.
AU - Abraham, Michael G.
AU - Wu, Teddy
AU - Kleinig, Timothy
AU - Lin, Longting
AU - Chen, Chushuang
AU - Levi, Christopher
AU - Dong, Qiang
AU - Cheng, Xin
AU - Butcher, Ken S.
AU - Choi, Philip
AU - Yassi, Nawaf
AU - Shah, Darshan
AU - Sharma, Gagan
AU - Pujara, Deep
AU - Shaker, Faris
AU - Blackburn, Spiros
AU - Dewey, Helen
AU - Thijs, Vincent
AU - Sitton, Clark W.
AU - Donnan, Geoffrey A.
AU - Mitchell, Peter J.
AU - Yan, Bernard
AU - Grotta, James G.
AU - Albers, Gregory W.
AU - Davis, Stephen M.
AU - Campbell, Bruce
AU - SELECT Investigators, the EXTEND-IA Investigators, the EXTEND-IA TNK Investigators, the EXTEND-IA TNK Part II Investigators, and the INSPIRE Study Group
N1 - Funding Information:
The SELECT study was funded by a grant from Stryker Neurovascular to the University of Texas McGovern Medical School at Houston. The EXTEND‐IA and EXTEND‐IA TNK, and EXTEND‐IA TNK Part II trials were supported by grants from the Australian National Health and Medical Research Council of Australia, Royal Australasian College of Physicians, Royal Melbourne Hospital Foundation, the National Heart Foundation of Australia, and the National Stroke Foundation of Australia, and by infrastructure funding from the state government of Victoria. For EXTEND‐IA, the Solitaire FR device and trial infrastructure were provided under an unrestricted grant from Covidien. The EXTEND‐IA TNK trial was also supported by an unrestricted grant from Medtronic. The INSPIRE Stroke registry was funded by the National Health and Medical Research Council Partnership Project. The funders had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.
Funding Information:
The SELECT study was funded by a grant from Stryker Neurovascular to the University of Texas McGovern Medical School at Houston. The EXTEND-IA and EXTEND-IA TNK, and EXTEND-IA TNK Part II trials were supported by grants from the Australian National Health and Medical Research Council of Australia, Royal Australasian College of Physicians, Royal Melbourne Hospital Foundation, the National Heart Foundation of Australia, and the National Stroke Foundation of Australia, and by infrastructure funding from the state government of Victoria. For EXTEND-IA, the Solitaire FR device and trial infrastructure were provided under an unrestricted grant from Covidien. The EXTEND-IA TNK trial was also supported by an unrestricted grant from Medtronic. The INSPIRE Stroke registry was funded by the National Health and Medical Research Council Partnership Project. The funders had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.
Publisher Copyright:
© 2022 American Neurological Association.
PY - 2022/5
Y1 - 2022/5
N2 - Objective: The objective of this study was to evaluate functional and safety outcomes of endovascular thrombectomy (EVT) versus medical management (MM) in patients with M2 occlusion and examine their association with perfusion imaging mismatch and stroke severity. Methods: In a pooled, patient-level analysis of 3 randomized controlled trials (EXTEND-IA, EXTEND-and IA-TNK parts 1 and 2) and 2 prospective nonrandomized studies (INSPIRE and SELECT), we evaluated EVT association with 90-day functional independence (modified Rankin Scale [mRS] = 0–2) in isolated M2 occlusions as compared to medical management overall and in subgroups by mismatch profile status and stroke severity. Results: We included 517 patients (EVT = 195 and MM = 322), baseline median (interquartile range [IQR]) National Institutes of Health Stroke Scale (NIHSS) was 13 (8–19) in EVT versus 10 (6–15) in MM, p < 0.001. Pretreatment ischemic core did not differ (EVT = 10 [0–24] ml vs MM = 9 [3–21] ml, p = 0.59). Compared to MM, EVT was more frequently associated with functional independence (68.3 vs 61.6%, adjusted odds ratio [aOR] = 2.42, 95% confidence interval [CI] = 1.25–4.67, p = 0.008, inverse probability of treatment weights [IPTW]-OR = 1.75, 95% CI = 1.00–3.75, p = 0.05) with a shift toward better mRS outcomes (adjusted cOR = 2.02, 95% CI:1.23–3.29, p = 0.005), and lower mortality (5 vs 10%, aOR = 0.32, 95% CI = 0.12–0.87, p = 0.025). EVT was associated with higher functional independence in patients with a perfusion mismatch profile (EVT = 70.7% vs MM = 61.3%, aOR = 2.29, 95% CI = 1.09–4.79, p = 0.029, IPTW-OR = 2.02, 1.08–3.78, p = 0.029), whereas no difference was found in those without mismatch (EVT = 43.8% vs MM = 62.7%, p = 0.17, IPTW-OR: 0.71, 95% CI = 0.18–2.78, p = 0.62). Functional independence was more frequent with EVT in patients with moderate or severe strokes, as defined by baseline NIHSS above any thresholds from 6 to 10, whereas there was no difference between groups with milder strokes below these thresholds. Interpretation: In patients with M2 occlusion, EVT was associated with improved clinical outcomes when compared to MM. This association was primarily observed in patients with a mismatch profile and those with higher stroke severity. ANN NEUROL 2022;91:629–639.
AB - Objective: The objective of this study was to evaluate functional and safety outcomes of endovascular thrombectomy (EVT) versus medical management (MM) in patients with M2 occlusion and examine their association with perfusion imaging mismatch and stroke severity. Methods: In a pooled, patient-level analysis of 3 randomized controlled trials (EXTEND-IA, EXTEND-and IA-TNK parts 1 and 2) and 2 prospective nonrandomized studies (INSPIRE and SELECT), we evaluated EVT association with 90-day functional independence (modified Rankin Scale [mRS] = 0–2) in isolated M2 occlusions as compared to medical management overall and in subgroups by mismatch profile status and stroke severity. Results: We included 517 patients (EVT = 195 and MM = 322), baseline median (interquartile range [IQR]) National Institutes of Health Stroke Scale (NIHSS) was 13 (8–19) in EVT versus 10 (6–15) in MM, p < 0.001. Pretreatment ischemic core did not differ (EVT = 10 [0–24] ml vs MM = 9 [3–21] ml, p = 0.59). Compared to MM, EVT was more frequently associated with functional independence (68.3 vs 61.6%, adjusted odds ratio [aOR] = 2.42, 95% confidence interval [CI] = 1.25–4.67, p = 0.008, inverse probability of treatment weights [IPTW]-OR = 1.75, 95% CI = 1.00–3.75, p = 0.05) with a shift toward better mRS outcomes (adjusted cOR = 2.02, 95% CI:1.23–3.29, p = 0.005), and lower mortality (5 vs 10%, aOR = 0.32, 95% CI = 0.12–0.87, p = 0.025). EVT was associated with higher functional independence in patients with a perfusion mismatch profile (EVT = 70.7% vs MM = 61.3%, aOR = 2.29, 95% CI = 1.09–4.79, p = 0.029, IPTW-OR = 2.02, 1.08–3.78, p = 0.029), whereas no difference was found in those without mismatch (EVT = 43.8% vs MM = 62.7%, p = 0.17, IPTW-OR: 0.71, 95% CI = 0.18–2.78, p = 0.62). Functional independence was more frequent with EVT in patients with moderate or severe strokes, as defined by baseline NIHSS above any thresholds from 6 to 10, whereas there was no difference between groups with milder strokes below these thresholds. Interpretation: In patients with M2 occlusion, EVT was associated with improved clinical outcomes when compared to MM. This association was primarily observed in patients with a mismatch profile and those with higher stroke severity. ANN NEUROL 2022;91:629–639.
UR - http://www.scopus.com/inward/record.url?scp=85128493911&partnerID=8YFLogxK
U2 - 10.1002/ana.26331
DO - 10.1002/ana.26331
M3 - Article
C2 - 35184327
AN - SCOPUS:85128493911
SN - 0364-5134
VL - 91
SP - 629
EP - 639
JO - Annals of Neurology
JF - Annals of Neurology
IS - 5
ER -