Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2019 Oct 1;76(10):1147-1156.
doi: 10.1001/jamaneurol.2019.2109.

Outcomes of Endovascular Thrombectomy vs Medical Management Alone in Patients With Large Ischemic Cores: A Secondary Analysis of the Optimizing Patient's Selection for Endovascular Treatment in Acute Ischemic Stroke (SELECT) Study

Amrou Sarraj  1 , Ameer E Hassan  2   3   4 , Sean Savitz  1 , Clark Sitton  5 , James Grotta  1 , Peng Chen  6 , Chunyan Cai  7 , Gary Cutter  8 , Bita Imam  1 , Sujan Reddy  1 , Kaushik Parsha  1 , Deep Pujara  1 , Roy Riascos  5 , Nirav Vora  9 , Michael Abraham  10 , Haris Kamal  1 , Diogo C Haussen  11 , Andrew D Barreto  1 , Maarten Lansberg  12 , Rishi Gupta  13 , Gregory W Albers  12
Affiliations

Outcomes of Endovascular Thrombectomy vs Medical Management Alone in Patients With Large Ischemic Cores: A Secondary Analysis of the Optimizing Patient's Selection for Endovascular Treatment in Acute Ischemic Stroke (SELECT) Study

Amrou Sarraj et al. JAMA Neurol. .

Abstract

Importance: The efficacy and safety of endovascular thrombectomy (EVT) in patients with large ischemic cores remains unknown, to our knowledge.

Objective: To compare outcomes in patients with large ischemic cores treated with EVT and medical management vs medical management alone.

Design, setting, and participants: This prespecified analysis of the Optimizing Patient's Selection for Endovascular Treatment in Acute Ischemic Stroke (SELECT) trial, a prospective cohort study of imaging selection that was conducted in 9 US comprehensive stroke centers, enrolled patients between January 2016 and February 2018, and followed them up for 90 days. Patients with moderate to severe stroke and anterior circulation large-vessel occlusion presenting up to 24 hours from the time they were last known to be well were eligible for the cohort. Of these, patients with large ischemic cores on computed tomography (CT) (Alberta Stroke Program Early CT Score <6) or CT perfusion scanning (a volume with a relative cerebral blood flow <30% of ≥50 cm3) were included in analyses.

Exposures: Endovascular thrombectomy with medical management (MM) or MM only.

Main outcomes and measures: Functional outcomes at 90 days per modified Rankin scale; safety outcomes (mortality, symptomatic intracerebral hemorrhage, and neurological worsening).

Results: A total of 105 patients with large ischemic cores on either CT or CT perfusion images were included: 71 with Alberta Stroke Program Early CT Scores of 5 or less (EVT, 37; MM, 34), 74 with cores of 50 cm3 or greater on CT perfusion images (EVT, 39; MM, 35), and 40 who had large cores on both CT and CT perfusion images (EVT, 14; MM, 26). The median (interquartile range) age was 66 (60-75) years; 45 patients (43%) were female. Nineteen of 62 patients (31%) who were treated with EVT achieved functional independence (modified Rankin Scale scores, 0-2) vs 6 of 43 patients (14%) treated with MM only (odds ratio [OR], 3.27 [95% CI, 1.11-9.62]; P = .03). Also, EVT was associated with better functional outcomes (common OR, 2.12 [95% CI, 1.05-4.31]; P = .04), less infarct growth (44 vs 98 mL; P = .006), and smaller final infarct volume (97 vs 190 mL; P = .001) than MM. In the odds of functional independence, there was a 42% reduction per 10-cm3 increase in core volume (adjusted OR, 0.58 [95% CI, 0.39-0.87]; P = .007) and a 40% reduction per hour of treatment delay (adjusted OR, 0.60 [95% CI, 0.36-0.99]; P = .045). Of 10 patients who had EVT with core volumes greater than 100 cm3, none had a favorable outcome.

Conclusions and relevance: Although the odds of good outcomes for patients with large cores who receive EVT markedly decline with increasing core size and time to treatment, these data suggest potential benefits. Randomized clinical trials are needed.

PubMed Disclaimer

Conflict of interest statement

Conflict of Interest Disclosures: Dr Sarraj reports serving as the principal investigator of the SELECT 2: A Randomized Controlled Trial to Optimize Patient's Selection for Endovascular Treatment in Acute Ischemic Stroke trial, with an unrestricted grant from Stryker Neurovascular to University of Texas McGovern–Houston; as a consultant, speaker bureau member, and advisory board member for Stryker; and as a site principal investigator for the TREVO Registry and Endovascular Therapy Following Imaging Evaluation for Ischemic Stroke 3 (DEFUSE 3) trials. Dr Hassan is a consultant, speaker bureau member, and proctor for Medtronic and Microvention and a consultant and speaker bureau member for Stryker, Penumbra, GE Healthcare, Balt, and Genentech. Dr Gupta is a consultant for Stryker Neurovascular, Cerenovous, and Rapid Medical, as well as a speaker for Genentech and a recipient of grants from Zoll, outside the submitted work. Dr Cutter is on data and safety monitoring boards for AMO Pharmaceuticals, Biolinerx, Brainstem, Horizon Pharmaceuticals, Hisun Pharmaceuticals, Merck, Merck/Pfizer, Opko Biologics, Neurim, Novartis, Ophazyme, Sanofi-Aventis, Reata Pharmaceuticals, Receptos/Celgene, Teva Pharmaceuticals, the National Heart, Blood, and Lung Institute (Protocol Review Committee), and the Eunice Kennedy Shriver National Institute of Child Health and Human Development (Obstetric-fetal Pharmacology Research Unit oversight committee), as well as consulting or advisory boards for Atara Biotherapeutics, Axon, Biogen, Biotherapeutics, Argenix, Brainstorm Cell Therapeutics, Charleston Labs Inc, Click Therapeutics, Genzyme, Genentech, GW Pharma, Klein-Buendel Incorporated, Medimmune, Medday, Novartis, Osmotica Pharmaceuticals, Perception Neurosciences, Roche, Scifluor, Somahlution, Teva pharmaceuticals, TG Therapeutics, and University of Texas Houston. Dr Cutter is employed by the University of Alabama at Birmingham and is the president of Pythagoras Inc, a private consulting company located in Birmingham, Alabama. Dr Abraham is a consultant for Stryker Neurovascular and Penumbra Inc. Dr Albers has an ownership interest in the iSchemaView and is a consultant or on advisory boards for iSchemaView and Medtronic; in addition, Dr Albers had a patent to automated AIF issued. Dr Chen reports having received research grant funding from Stryker Neurovascular, outside the submitted work. Dr Vora is a speaker bureau member and consultant for Medtronic Neurovascular, Stryker Neurovascular, Microvention Neurovascular, and Elum Technologies. Dr Sitton reported grants from Stryker during the conduct of the study. Dr Lansberg reported personal fees from Novo Nordisk, Genentech, Biogen, Moleac, and NuvOx, outside the submitted work. No other disclosures were reported.

Figures

Figure 1.
Figure 1.. Flowchart of Patients Enrolled in the Optimizing Patient’s Selection for Endovascular Treatment in Acute Ischemic Stroke (SELECT) Study, Patients With Large Cores, and Distribution Based on Treatment and Imaging Profile
The number enrolled refers only to the 445 individuals who were eligible after screening and consented to participate. ASPECTS indicates Alberta Stroke Program Early CT Score; CT, computed tomography; and CTP, computed tomographic perfusion (imaging).
Figure 2.
Figure 2.. Ninety-Day Modified Rankin Scale Score Distribution in Patients Treated With Endovascular Thrombectomy vs Medical Management Only
Percentages do not add up to 100% owing to rounding.
Figure 3.
Figure 3.. Association of Time and Stroke Size With Thrombectomy Outcomes in Patients With Large Core on Computed Tomographic and Computed Tomographic Perfusion Images
A, Association of volume (with a relative cerebral blood flow [rCBF] <30%) and time with the probability of a good outcome (90-day modified Rankin Scale score, 0-2) with endovascular thrombectomy (with ischemic core volume in categories of 50-100 cm3 or >100 cm3). A good outcome is associated with core volume and time of computed tomographic (CT) perfusion imaging. There is a decrease in likelihood of a good outcome with increase in the volume and as the time progresses. B, Association of volume (with rCBF <30%) and time with the probability of good outcome with endovascular thrombectomy (ischemic core volume as a continuous variable). A good outcome is associated with the core volume and time of CT perfusion imaging. There is a decrease in the likelihood of a good outcome with increases in volume and time progression. C, Association of Alberta Stroke Program Early CT Score (ASPECTS) and time with the probability of good outcome (90-day modified Rankin Scale score, 0-2) with endovascular thrombectomy (an ASPECTS of 3, 4, or 5). The probability of good outcome is associated with time but does not differ significantly with ASPECTS. There is a decrease in the likelihood of a good outcome with decrease in the ASPECTS and time progression. D, Association of time only on the probability of good outcome with endovascular thrombectomy in patients with large core. The probability of a good outcome decreases significantly as time progresses, with very low probability (<10%) after 12 hours.
See this image and copyright information in PMC

Comment in

  • doi: 10.1001/jamaneurol.2019.1789

References

    1. Berkhemer OA, Fransen PS, Beumer D, et al. ; MR CLEAN Investigators . A randomized trial of intraarterial treatment for acute ischemic stroke. N Engl J Med. 2015;372(1):11-20. doi:10.1056/NEJMoa1411587 - DOI - PubMed
    1. Saver JL, Goyal M, Bonafe A, et al. ; SWIFT PRIME Investigators . Stent-retriever thrombectomy after intravenous t-PA vs. t-PA alone in stroke. N Engl J Med. 2015;372(24):2285-2295. doi:10.1056/NEJMoa1415061 - DOI - PubMed
    1. Jovin TG, Chamorro A, Cobo E, et al. ; REVASCAT Trial Investigators . Thrombectomy within 8 hours after symptom onset in ischemic stroke. N Engl J Med. 2015;372(24):2296-2306. doi:10.1056/NEJMoa1503780 - DOI - PubMed
    1. Goyal M, Demchuk AM, Menon BK, et al. ; ESCAPE Trial Investigators . Randomized assessment of rapid endovascular treatment of ischemic stroke. N Engl J Med. 2015;372(11):1019-1030. doi:10.1056/NEJMoa1414905 - DOI - PubMed
    1. Campbell BC, Mitchell PJ, Kleinig TJ, et al. ; EXTEND-IA Investigators . Endovascular therapy for ischemic stroke with perfusion-imaging selection. N Engl J Med. 2015;372(11):1009-1018. doi:10.1056/NEJMoa1414792 - DOI - PubMed