TY - JOUR
T1 - Outcomes after Endovascular Thrombectomy with or Without Alteplase in Routine Clinical Practice
AU - Smith, Eric E.
AU - Zerna, Charlotte
AU - Solomon, Nicole
AU - Matsouaka, Roland
AU - Mac Grory, Brian
AU - Saver, Jeffrey L.
AU - Hill, Michael D.
AU - Fonarow, Gregg C.
AU - Schwamm, Lee H.
AU - Messé, Steven R.
AU - Xian, Ying
N1 - Funding Information:
reported receiving funding from the American Heart Association Get With The Guidelines–Stroke program. Dr Saver reported receiving consulting fees from Medtronic, Cerenovus, Boehringer Ingelheim, Bayer, Rapid Medical, Stryker, BrainsGate, and BrainQ during the conduct of the study. Dr Hill reported receiving grants from Biogen, Medtronic, NoNO Inc, and Boehringer Ingelheim to the University of Calgary outside the submitted work; having a patent licensed to Circle Neurovascular Inc; serving as director and owning shares in Circle Neurovascular Inc; and serving as director for Canadian Neuroscience Federation and the Canadian Stroke Consortium. Dr Fonarow reported being an employee of the University of California, which has a patent on an endovascular device and serving as Associate Section Editor of JAMA Cardiology. Dr Schwamm reported receiving consulting fees from Genentech regarding trial design in late window thrombolysis and thrombectomy; being member of the Steering Committee for Genentech’s TIMELESS trial and a member of data safety monitoring boards for Penumbra and Diffusion Pharma; serving as national principal investigator for the Stroke AF trial in stroke prevention by Medtronics and the site principal investigator for the New England Regional Coordinating Center for the NINDS StrokeNet Network; providing continuing medical education for Medscape, Mediasphere, and PRIME education; receiving consultant fees from Genentech; and receiving personal fees from Penumbra, Diffusion Pharma, Medscape, PRIME education, and Mediasphere outside the submitted work. Dr Messé reported being cofounder of and having shares in Neuralert Technologies and having a patent pending for monitoring of upper limb movements to detect stroke. Dr Xian reported grants from American Heart Association, Genentech, and the National Institute on Aging and honorarium from Boehringer Ingelheim during the conduct of the study. No other disclosures were reported.
Funding Information:
part from the American Heart Association/ American Stroke Association, which provides support to The Get With The Guidelines–Stroke program. The Get With The Guidelines–Stroke program is sponsored, in part, by Novartis, Boehringer Ingelheim and Eli Lilly Diabetes Alliance, Novo Nordisk, Sanofi, AstraZeneca, Bayer, Tylenol and Alexion Pharmaceuticals.
Publisher Copyright:
© 2022 American Medical Association. All rights reserved.
PY - 2022/8
Y1 - 2022/8
N2 - Importance: The effectiveness and safety of intravenous alteplase given before or concurrently with endovascular thrombectomy (EVT) is uncertain. Randomized clinical trials suggest there is little difference in outcomes but with only modest precision and insufficient power to analyze uncommon outcomes including symptomatic intracranial hemorrhage (sICH). Objective: To determine whether 8 prespecified outcomes are different in patients with acute ischemic stroke treated in routine clinical practice with EVT with alteplase compared with patients treated with EVT alone without alteplase. It was hypothesized that alteplase would be associated with higher risk of sICH. Design, Setting, and Participants: This was an observational cohort study conducted from February 1, 2019, to June 30, 2020, that included adult patients with acute ischemic stroke treated with EVT within 6 hours of time last known well, after excluding patients without information on discharge destination and patients with in-hospital stroke. Participants were recruited from Get With The Guidelines-Stroke, a large nationwide registry of patients with acute ischemic stroke from 555 hospitals in the US. Exposures: Intravenous alteplase or no alteplase. Main Outcomes and Measures: Prespecified outcomes were discharge destination, independent ambulation at discharge, modified Rankin score at discharge, discharge mortality, cerebral reperfusion according to modified Thrombolysis in Cerebral Infarction grade, and sICH. Results: There were 15832 patients treated with EVT (median [IQR] age, 72.0 [61.0-82.0] years; 7932 women [50.1%]); 10548 (66.7%) received alteplase and 5284 (33.4%) did not. Patients treated with alteplase were younger, arrived via Emergency Medical Services sooner, were less likely to have certain comorbidities, including atrial fibrillation, hypertension, and diabetes, but had similar National Institutes of Health Stroke Severity (NIHSS) scores. Compared with patients who did not receive alteplase treatment, patients treated with alteplase were less likely to die (11.1% [1173 of 10548 patients] vs 13.9% [734 of 5284 patients]; adjusted odds ratio [aOR] 0.83; 95% CI, 0.77-0.89; P <.001), more likely to have no major disability based on modified Rankin scale of 2 or less at discharge (28.5% [2415 of 8490 patients] vs 20.7% [894 of 4322 patients]; aOR, 1.36; 95% CI, 1.28-1.45; P <.001), and to have better reperfusion based on modified Thrombolysis in Cerebral Infarction grade 2b or greater (90.9% [8474 of 9318 patients] vs 88.0% [4140 of 4705 patients]; aOR, 1.39; 95% CI, 1.28-1.50; P <.001). However, alteplase treatment was associated with higher risk of sICH (6.5% [685 of 10530 patients] vs 5.3% [279 of 5249 patients]; OR, 1.28; 95% CI, 1.16-1.42; P <.001). Conclusions and Relevance: In this observational cohort study of patients treated with EVT, intravenous alteplase treatment was associated with better in-hospital survival and functional outcomes but higher sICH risk after adjusting for other covariates.
AB - Importance: The effectiveness and safety of intravenous alteplase given before or concurrently with endovascular thrombectomy (EVT) is uncertain. Randomized clinical trials suggest there is little difference in outcomes but with only modest precision and insufficient power to analyze uncommon outcomes including symptomatic intracranial hemorrhage (sICH). Objective: To determine whether 8 prespecified outcomes are different in patients with acute ischemic stroke treated in routine clinical practice with EVT with alteplase compared with patients treated with EVT alone without alteplase. It was hypothesized that alteplase would be associated with higher risk of sICH. Design, Setting, and Participants: This was an observational cohort study conducted from February 1, 2019, to June 30, 2020, that included adult patients with acute ischemic stroke treated with EVT within 6 hours of time last known well, after excluding patients without information on discharge destination and patients with in-hospital stroke. Participants were recruited from Get With The Guidelines-Stroke, a large nationwide registry of patients with acute ischemic stroke from 555 hospitals in the US. Exposures: Intravenous alteplase or no alteplase. Main Outcomes and Measures: Prespecified outcomes were discharge destination, independent ambulation at discharge, modified Rankin score at discharge, discharge mortality, cerebral reperfusion according to modified Thrombolysis in Cerebral Infarction grade, and sICH. Results: There were 15832 patients treated with EVT (median [IQR] age, 72.0 [61.0-82.0] years; 7932 women [50.1%]); 10548 (66.7%) received alteplase and 5284 (33.4%) did not. Patients treated with alteplase were younger, arrived via Emergency Medical Services sooner, were less likely to have certain comorbidities, including atrial fibrillation, hypertension, and diabetes, but had similar National Institutes of Health Stroke Severity (NIHSS) scores. Compared with patients who did not receive alteplase treatment, patients treated with alteplase were less likely to die (11.1% [1173 of 10548 patients] vs 13.9% [734 of 5284 patients]; adjusted odds ratio [aOR] 0.83; 95% CI, 0.77-0.89; P <.001), more likely to have no major disability based on modified Rankin scale of 2 or less at discharge (28.5% [2415 of 8490 patients] vs 20.7% [894 of 4322 patients]; aOR, 1.36; 95% CI, 1.28-1.45; P <.001), and to have better reperfusion based on modified Thrombolysis in Cerebral Infarction grade 2b or greater (90.9% [8474 of 9318 patients] vs 88.0% [4140 of 4705 patients]; aOR, 1.39; 95% CI, 1.28-1.50; P <.001). However, alteplase treatment was associated with higher risk of sICH (6.5% [685 of 10530 patients] vs 5.3% [279 of 5249 patients]; OR, 1.28; 95% CI, 1.16-1.42; P <.001). Conclusions and Relevance: In this observational cohort study of patients treated with EVT, intravenous alteplase treatment was associated with better in-hospital survival and functional outcomes but higher sICH risk after adjusting for other covariates.
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U2 - 10.1001/jamaneurol.2022.1413
DO - 10.1001/jamaneurol.2022.1413
M3 - Article
C2 - 35696198
AN - SCOPUS:85132815335
SN - 2168-6149
VL - 79
SP - 768
EP - 776
JO - JAMA neurology
JF - JAMA neurology
IS - 8
ER -