TY - JOUR
T1 - Achieving More Rapid Door-to-Needle Times and Improved Outcomes in Acute Ischemic Stroke in a Nationwide Quality Improvement Intervention
AU - Xian, Ying
AU - Xu, Haolin
AU - Smith, Eric E.
AU - Saver, Jeffrey L.
AU - Reeves, Mathew J.
AU - Bhatt, Deepak L.
AU - Hernandez, Adrian F.
AU - Peterson, Eric D.
AU - Schwamm, Lee H.
AU - Fonarow, Gregg C.
N1 - Funding Information:
Dr Xian reports research funding to Duke Clinical Research Institute from the American Heart Association, Genentech; and honoraria from Boehringer Ingelheim. Dr Smith reports consulting fees from Biogen, Bayer and Javelin; and royalties from UpToDate. Dr Saver reports being an employee of the University of California, which has patent rights in retrieval devices for stroke. Dr Saver reports serving as an unpaid site investigator in multicenter trials sponsored by Medtronic, Stryker, Johnson & Johnson, and Boehringer Ingelheim (prevention only), for which the University of California Regents received payments on the basis of clinical trial contracts for the number of patients enrolled; receipt of contracted hourly payments for services as a scientific consultant advising on rigorous trial design and conduct to Medtronic, Stryker, Johnson & Johnson, and Boehringer Ingelheim (prevention only); and contracted stock options for services as a scientific consultant advising on rigorous trial design and conduct to Rapid Medical. Dr Reeves reports receiving salary support from the Michigan Stroke GWTG Registry. Dr Bhatt discloses the following relationships—Advisory Board: Cardax, CellProthera, Cereno Scientific, Elsevier Practice Update Cardology, Janssen, Level Ex, Medscape Cardiology, MyoKardia, Novo Nordisk, PhaseBio, PLx Pharma, Regado Biosciences; Board of Directors: Boston VA Research Institute, Society of Cardiovascular Patient Care, TobeSoft; Chair: American Heart Association Quality Oversight Committee; Data Monitoring Committees: Baim Institute for Clinical Research (formerly Harvard Clinical Research Institute, for the PORTICO trial [Portico Re-sheathable Transcatheter Aortic Valve System US IDE Trial], funded by St Jude Medical, now Abbott), Cleveland Clinic (including for the ExCEED trial [Efficacy of Secukinumab Compared to Adalimumab in Patients With Psoriatic Arthritis], funded by Edwards), Contego Medical (Chair, PERFORMANCE 2 [Protection Against Emboli During Carotid Artery Stenting Using the Neuroguard IEP System]), Duke Clinical Research Institute, Mayo Clinic, Mount Sinai School of Medicine (for the ENVISAGE trial [Edoxaban Compared to Standard Care After Heart Valve Replacement Using a Catheter in Patients With Atrial Fibrillation], funded by Daiichi Sankyo), Population Health Research Institute; Honoraria: American College of Cardiology (Senior Associate Editor, Clinical Trials and News, ACC.org; Chair, ACC Accreditation Committee), Baim Institute for Clinical Research (formerly Harvard Clinical Research Institute; RE-DUAL PCI [Evaluation of Dual Therapy With Dabigatran vs Triple Therapy With Warfarin in Patients With AF That Undergo a PCI With Stenting] clinical trial steering committee funded by Boehringer Ingelheim; AEGIS-II [Study to Investigate CSL112 in Subjects With Acute Coronary Syndrome] executive committee funded by CSL Behring), Belvoir Publications (Editor in Chief, Harvard Heart Letter), Canadian Medical and Surgical Knowledge Translation Research Group (clinical trial steering committees), Duke Clinical Research Institute (clinical trial steering committees, including for the PRONOUNCE trial, funded by Ferring Pharmaceuticals), HMP Global (Editor in Chief, Journal of Invasive Cardiology), Journal of the American College of Cardiology (Guest Editor; Associate Editor), K2P (Co-Chair, interdisciplinary curriculum), Level Ex, Medtelligence/ReachMD (CME steering committees), MJH Life Sciences, Population Health Research Institute (for the COMPASS [Rivaroxaban for the Prevention of Major Cardiovascular Events in Coronary or Peripheral Artery Disease] operations committee, publications committee, steering committee, and USA national co-leader, funded by Bayer), Slack Publications (Chief Medical Editor, Cardiology Today’s Intervention), Society of Cardiovascular Patient Care (Secretary/Treasurer), WebMD (CME steering committees); Other: Clinical Cardiology (Deputy Editor), NCDR-ACTION (National Cardiovascular Data Registry-ACTION) Registry Steering Committee (Chair), VA CART Research and Publications Committee (Chair); Research Funding: Abbott, Afimmune, Amarin, Amgen, AstraZeneca, Bayer, Boehringer Ingelheim, Bristol-Myers Squibb, Cardax, CellProthera, Cereno Scientific, Chiesi, CSL Behring, Eisai, Ethicon, Ferring Pharmaceuticals, Forest Laboratories, Fractyl, Garmin, HLS Therapeutics, Idorsia, Ironwood, Ischemix, Janssen, Lexicon, Lilly, Medtronic, MyoKardia, Novartis, Novo Nordisk, Owkin, Pfizer, PhaseBio, PLx Pharma, Regeneron, Roche, Sanofi, Synaptic, The Medicines Company, 89Bio; Royalties: Elsevier (Editor, Cardiovascular Intervention: A Companion to Braunwald’s Heart Disease); Site Co-Investigator: Abbott, Biotronik, Boston Scientific, CSI, St. Jude Medical (now Abbott), Svelte; Trustee: American College of Cardiology; Unfunded Research: FlowCo, Merck, Takeda. Dr Hernandez reports Research funding from AstraZeneca, Boehringer Ingelheim, Daiichi, Genentech, Lilly, Janssen, Merck, and honorarium from, Amgen, AstraZeneca, Bayer, Boehringer Ingelheim, Lilly, Merck, and Novartis. Dr Peterson reported receipt of grants from Genentech and Regeneron; and grants and personal fees from Sanofi, Astra Zenica, Amarin, and Amgen outside the submitted work. Dr Schwamm reports serving as a scientific consultant to Penumbra (Data and Safety Monitoring Board for MIND trial), Genentech (steering committee [TIMELESS trial (Tenecteplase in Stroke Patients Between 4.5 and 24 Hours)]), Medtronic (Stroke AF trials), Diffusion Pharma (Data and Safety Monitoring Board for PHAST-TSC [Efficacy and Safety of Trans Sodium Crocetinate (TSC) for Treatment of Suspected Stroke]), and providing educational content development or lectures for Boehringer Ingelheim, Medscape, Mediasphere. Dr Fonarow reports being an employee of the University of California that has a patent on an endovascular device. The other authors report no conflicts.
Funding Information:
The Get With The Guidelines–Stroke (GWTG-Stroke) registry and Target: Stroke program are provided by the American Heart Association/American Stroke Association. GWTG-Stroke is sponsored, in part, by Novartis, Boehringer Ingelheim Lilly, Novo Nordisk, Sanofi, AstraZeneca, Bayer, and Portola Pharmaceuticals. The funding organization has no role in 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 Heart Association, Inc.
PY - 2022/4/1
Y1 - 2022/4/1
N2 - Background: The benefits of tPA (tissue-type plasminogen activator) in acute ischemic stroke are time-dependent. However, delivery of thrombolytic therapy rapidly after hospital arrival was initially occurring infrequently in hospitals in the United States, discrepant with national guidelines. Methods: We evaluated door-to-needle (DTN) times and clinical outcomes among patients with acute ischemic stroke receiving tPA before and after initiation of 2 successive nationwide quality improvement initiatives: Target: Stroke Phase I (2010-2013) and Target: Stroke Phase II (2014-2018) from 913 Get With The Guidelines-Stroke hospitals in the United States between April 2003 and September 2018. Results: Among 154 221 patients receiving tPA within 3 hours of stroke symptom onset (median age 72 years, 50.1% female), median DTN times decreased from 78 minutes (interquartile range, 60-98) preintervention, to 66 minutes (51-87) during Phase I, and 50 minutes (37-66) during Phase II (P<0.001). Proportions of patients with DTN ≤60 minutes increased from 26.4% to 42.7% to 68.6% (P<0.001). Proportions of patients with DTN ≤45 minutes increased from 10.1% to 17.7% to 41.4% (P<0.001). By the end of the second intervention, 75.4% and 51.7% patients achieved 60-minute and 45-minute DTN goals. Compared with the preintervention period, hospitals during the second intervention period (2014-2018) achieved higher rates of tPA use (11.7% versus 5.6%; adjusted odds ratio, 2.43 [95% CI, 2.31-2.56]), lower in-hospital mortality (6.0% versus 10.0%; adjusted odds ratio, 0.69 [0.64-0.73]), fewer bleeding complication (3.4% versus 5.5%; adjusted odds ratio, 0.68 [0.62-0.74]), and higher rates of discharge to home (49.6% versus 35.7%; adjusted odds ratio, 1.43 [1.38-1.50]). Similar findings were found in sensitivity analyses of 185 501 patients receiving tPA within 4.5 hours of symptom onset. Conclusions: A nationwide quality improvement program for acute ischemic stroke was associated with substantial improvement in the timeliness of thrombolytic therapy start, increased thrombolytic treatment, and improved clinical outcomes.
AB - Background: The benefits of tPA (tissue-type plasminogen activator) in acute ischemic stroke are time-dependent. However, delivery of thrombolytic therapy rapidly after hospital arrival was initially occurring infrequently in hospitals in the United States, discrepant with national guidelines. Methods: We evaluated door-to-needle (DTN) times and clinical outcomes among patients with acute ischemic stroke receiving tPA before and after initiation of 2 successive nationwide quality improvement initiatives: Target: Stroke Phase I (2010-2013) and Target: Stroke Phase II (2014-2018) from 913 Get With The Guidelines-Stroke hospitals in the United States between April 2003 and September 2018. Results: Among 154 221 patients receiving tPA within 3 hours of stroke symptom onset (median age 72 years, 50.1% female), median DTN times decreased from 78 minutes (interquartile range, 60-98) preintervention, to 66 minutes (51-87) during Phase I, and 50 minutes (37-66) during Phase II (P<0.001). Proportions of patients with DTN ≤60 minutes increased from 26.4% to 42.7% to 68.6% (P<0.001). Proportions of patients with DTN ≤45 minutes increased from 10.1% to 17.7% to 41.4% (P<0.001). By the end of the second intervention, 75.4% and 51.7% patients achieved 60-minute and 45-minute DTN goals. Compared with the preintervention period, hospitals during the second intervention period (2014-2018) achieved higher rates of tPA use (11.7% versus 5.6%; adjusted odds ratio, 2.43 [95% CI, 2.31-2.56]), lower in-hospital mortality (6.0% versus 10.0%; adjusted odds ratio, 0.69 [0.64-0.73]), fewer bleeding complication (3.4% versus 5.5%; adjusted odds ratio, 0.68 [0.62-0.74]), and higher rates of discharge to home (49.6% versus 35.7%; adjusted odds ratio, 1.43 [1.38-1.50]). Similar findings were found in sensitivity analyses of 185 501 patients receiving tPA within 4.5 hours of symptom onset. Conclusions: A nationwide quality improvement program for acute ischemic stroke was associated with substantial improvement in the timeliness of thrombolytic therapy start, increased thrombolytic treatment, and improved clinical outcomes.
KW - ischemic stroke
KW - odds ratio
KW - quality improvement
KW - thrombolytic therapy
KW - tissue-type plasminogen activator
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U2 - 10.1161/STROKEAHA.121.035853
DO - 10.1161/STROKEAHA.121.035853
M3 - Article
C2 - 34802250
AN - SCOPUS:85127946000
SN - 0039-2499
VL - 53
SP - 1328
EP - 1338
JO - Stroke
JF - Stroke
IS - 4
ER -