A trial of imaging selection and endovascular treatment for ischemic stroke

Stella Kidwell, Reza Jahan, Jeffrey Gornbein, Jeffry R. Alger, Val Nenov, Zahra Ajani, Lei Feng, Brett C. Meyer, Scott Olson, Lee H. Schwamm, Albert J. Yoo, Randolph S. Marshall, Philip M. Meyers, Dileep R. Yavagal, Max Wintermark, Judy Guzy, Sidney Starkman, Jeffrey L. Saver

Research output: Contribution to journalArticle

940 Citations (Scopus)

Abstract

BACKGROUND: Whether brain imaging can identify patients who are most likely to benefit from therapies for acute ischemic stroke and whether endovascular thrombectomy improves clinical outcomes in such patients remains unclear. METHODS: In this study, we randomly assigned patients within 8 hours after the onset of large-vessel, anterior-circulation strokes to undergo mechanical embolectomy (Merci Retriever or Penumbra System) or receive standard care. All patients underwent pretreatment computed tomography or magnetic resonance imaging of the brain. Randomization was stratified according to whether the patient had a favorable penumbral pattern (substantial salvageable tissue and small infarct core) or a non-penumbral pattern (large core or small or absent penumbra). We assessed outcomes using the 90-day modified Rankin scale, ranging from 0 (no symptoms) to 6 (dead). RESULTS: Among 118 eligible patients, the mean age was 65.5 years, the mean time to enrollment was 5.5 hours, and 58% had a favorable penumbral pattern. Revascularization in the embolectomy group was achieved in 67% of the patients. Ninety-day mortality was 21%, and the rate of symptomatic intracranial hemorrhage was 4%; neither rate differed across groups. Among all patients, mean scores on the modified Rankin scale did not differ between embolectomy and standard care (3.9 vs. 3.9, P = 0.99). Embolectomy was not superior to standard care in patients with either a favorable penumbral pattern (mean score, 3.9 vs. 3.4; P = 0.23) or a nonpenumbral pattern (mean score, 4.0 vs. 4.4; P = 0.32). In the primary analysis of scores on the 90-day modified Rankin scale, there was no interaction between the pretreatment imaging pattern and treatment assignment (P = 0.14). CONCLUSIONS: A favorable penumbral pattern on neuroimaging did not identify patients who would differentially benefit from endovascular therapy for acute ischemic stroke, nor was embolectomy shown to be superior to standard care. (Funded by the National Institute of Neurological Disorders and Stroke; MR RESCUE ClinicalTrials.gov number, NCT00389467.)

Original languageEnglish (US)
Pages (from-to)914-923
Number of pages10
JournalNew England Journal of Medicine
Volume368
Issue number10
DOIs
StatePublished - Mar 7 2013
Externally publishedYes

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Stroke
Embolectomy
Therapeutics
Neuroimaging
National Institute of Neurological Disorders and Stroke
Thrombectomy
Intracranial Hemorrhages
Random Allocation
Patient Care
Tomography
Magnetic Resonance Imaging
Mortality
Brain

ASJC Scopus subject areas

  • Medicine(all)

Cite this

Kidwell, S., Jahan, R., Gornbein, J., Alger, J. R., Nenov, V., Ajani, Z., ... Saver, J. L. (2013). A trial of imaging selection and endovascular treatment for ischemic stroke. New England Journal of Medicine, 368(10), 914-923. https://doi.org/10.1056/NEJMoa1212793

A trial of imaging selection and endovascular treatment for ischemic stroke. / Kidwell, Stella; Jahan, Reza; Gornbein, Jeffrey; Alger, Jeffry R.; Nenov, Val; Ajani, Zahra; Feng, Lei; Meyer, Brett C.; Olson, Scott; Schwamm, Lee H.; Yoo, Albert J.; Marshall, Randolph S.; Meyers, Philip M.; Yavagal, Dileep R.; Wintermark, Max; Guzy, Judy; Starkman, Sidney; Saver, Jeffrey L.

In: New England Journal of Medicine, Vol. 368, No. 10, 07.03.2013, p. 914-923.

Research output: Contribution to journalArticle

Kidwell, S, Jahan, R, Gornbein, J, Alger, JR, Nenov, V, Ajani, Z, Feng, L, Meyer, BC, Olson, S, Schwamm, LH, Yoo, AJ, Marshall, RS, Meyers, PM, Yavagal, DR, Wintermark, M, Guzy, J, Starkman, S & Saver, JL 2013, 'A trial of imaging selection and endovascular treatment for ischemic stroke', New England Journal of Medicine, vol. 368, no. 10, pp. 914-923. https://doi.org/10.1056/NEJMoa1212793
Kidwell, Stella ; Jahan, Reza ; Gornbein, Jeffrey ; Alger, Jeffry R. ; Nenov, Val ; Ajani, Zahra ; Feng, Lei ; Meyer, Brett C. ; Olson, Scott ; Schwamm, Lee H. ; Yoo, Albert J. ; Marshall, Randolph S. ; Meyers, Philip M. ; Yavagal, Dileep R. ; Wintermark, Max ; Guzy, Judy ; Starkman, Sidney ; Saver, Jeffrey L. / A trial of imaging selection and endovascular treatment for ischemic stroke. In: New England Journal of Medicine. 2013 ; Vol. 368, No. 10. pp. 914-923.
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AU - Kidwell, Stella

AU - Jahan, Reza

AU - Gornbein, Jeffrey

AU - Alger, Jeffry R.

AU - Nenov, Val

AU - Ajani, Zahra

AU - Feng, Lei

AU - Meyer, Brett C.

AU - Olson, Scott

AU - Schwamm, Lee H.

AU - Yoo, Albert J.

AU - Marshall, Randolph S.

AU - Meyers, Philip M.

AU - Yavagal, Dileep R.

AU - Wintermark, Max

AU - Guzy, Judy

AU - Starkman, Sidney

AU - Saver, Jeffrey L.

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Y1 - 2013/3/7

N2 - BACKGROUND: Whether brain imaging can identify patients who are most likely to benefit from therapies for acute ischemic stroke and whether endovascular thrombectomy improves clinical outcomes in such patients remains unclear. METHODS: In this study, we randomly assigned patients within 8 hours after the onset of large-vessel, anterior-circulation strokes to undergo mechanical embolectomy (Merci Retriever or Penumbra System) or receive standard care. All patients underwent pretreatment computed tomography or magnetic resonance imaging of the brain. Randomization was stratified according to whether the patient had a favorable penumbral pattern (substantial salvageable tissue and small infarct core) or a non-penumbral pattern (large core or small or absent penumbra). We assessed outcomes using the 90-day modified Rankin scale, ranging from 0 (no symptoms) to 6 (dead). RESULTS: Among 118 eligible patients, the mean age was 65.5 years, the mean time to enrollment was 5.5 hours, and 58% had a favorable penumbral pattern. Revascularization in the embolectomy group was achieved in 67% of the patients. Ninety-day mortality was 21%, and the rate of symptomatic intracranial hemorrhage was 4%; neither rate differed across groups. Among all patients, mean scores on the modified Rankin scale did not differ between embolectomy and standard care (3.9 vs. 3.9, P = 0.99). Embolectomy was not superior to standard care in patients with either a favorable penumbral pattern (mean score, 3.9 vs. 3.4; P = 0.23) or a nonpenumbral pattern (mean score, 4.0 vs. 4.4; P = 0.32). In the primary analysis of scores on the 90-day modified Rankin scale, there was no interaction between the pretreatment imaging pattern and treatment assignment (P = 0.14). CONCLUSIONS: A favorable penumbral pattern on neuroimaging did not identify patients who would differentially benefit from endovascular therapy for acute ischemic stroke, nor was embolectomy shown to be superior to standard care. (Funded by the National Institute of Neurological Disorders and Stroke; MR RESCUE ClinicalTrials.gov number, NCT00389467.)

AB - BACKGROUND: Whether brain imaging can identify patients who are most likely to benefit from therapies for acute ischemic stroke and whether endovascular thrombectomy improves clinical outcomes in such patients remains unclear. METHODS: In this study, we randomly assigned patients within 8 hours after the onset of large-vessel, anterior-circulation strokes to undergo mechanical embolectomy (Merci Retriever or Penumbra System) or receive standard care. All patients underwent pretreatment computed tomography or magnetic resonance imaging of the brain. Randomization was stratified according to whether the patient had a favorable penumbral pattern (substantial salvageable tissue and small infarct core) or a non-penumbral pattern (large core or small or absent penumbra). We assessed outcomes using the 90-day modified Rankin scale, ranging from 0 (no symptoms) to 6 (dead). RESULTS: Among 118 eligible patients, the mean age was 65.5 years, the mean time to enrollment was 5.5 hours, and 58% had a favorable penumbral pattern. Revascularization in the embolectomy group was achieved in 67% of the patients. Ninety-day mortality was 21%, and the rate of symptomatic intracranial hemorrhage was 4%; neither rate differed across groups. Among all patients, mean scores on the modified Rankin scale did not differ between embolectomy and standard care (3.9 vs. 3.9, P = 0.99). Embolectomy was not superior to standard care in patients with either a favorable penumbral pattern (mean score, 3.9 vs. 3.4; P = 0.23) or a nonpenumbral pattern (mean score, 4.0 vs. 4.4; P = 0.32). In the primary analysis of scores on the 90-day modified Rankin scale, there was no interaction between the pretreatment imaging pattern and treatment assignment (P = 0.14). CONCLUSIONS: A favorable penumbral pattern on neuroimaging did not identify patients who would differentially benefit from endovascular therapy for acute ischemic stroke, nor was embolectomy shown to be superior to standard care. (Funded by the National Institute of Neurological Disorders and Stroke; MR RESCUE ClinicalTrials.gov number, NCT00389467.)

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