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• W2995691319 abstract "HomeCirculationVol. 140, No. 23Hospitalization Among Patients With Atrial Fibrillation and a Recent Acute Coronary Syndrome or Percutaneous Coronary Intervention Treated With Apixaban or Aspirin Free AccessLetterPDF/EPUBAboutView PDFView EPUBSections ToolsAdd to favoritesDownload citationsTrack citationsPermissions ShareShare onFacebookTwitterLinked InMendeleyReddit Jump toFree AccessLetterPDF/EPUBHospitalization Among Patients With Atrial Fibrillation and a Recent Acute Coronary Syndrome or Percutaneous Coronary Intervention Treated With Apixaban or AspirinInsights From the AUGUSTUS Trial Amit N. Vora, MD, MPH, John H. Alexander, MD, MHS, Daniel M. Wojdyla, MS, Ronald Aronson, MD, Christopher B. Granger, MD, Harald Darius, MD, Stephan Windecker, MD, Roxana Mehran, MD, Oleg Averkov, MD, PhD, Andrzej Budaj, MD, PhD, David F. Kong, MD, AM, Zhanna Kobalava, MD, PhD, Rajendra H. Mehta, MD, MS, Zulfiqar Mirza, MD, Patricia Oliveira Guimaraes, MD, PhD, Alexander Parkhomenko, MD, PhD, Alexandre Quadros, MD, PhD, Holger Thiele, MD, Shaun G. Goodman, MD, MSc and Renato D. Lopes, MD, PhD Amit N. VoraAmit N. Vora UPMC Pinnacle, Harrisburg, PA (A.N.V.). Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC (A.N.V., J.H.A., D.M.W., C.B.G., D.F.K., R.H.M., R.D.L.). Search for more papers by this author , John H. AlexanderJohn H. Alexander Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC (A.N.V., J.H.A., D.M.W., C.B.G., D.F.K., R.H.M., R.D.L.). Search for more papers by this author , Daniel M. WojdylaDaniel M. Wojdyla Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC (A.N.V., J.H.A., D.M.W., C.B.G., D.F.K., R.H.M., R.D.L.). Search for more papers by this author , Ronald AronsonRonald Aronson Bristol-Myers Squibb, Lawrenceville, NJ (R.A.). Search for more papers by this author , Christopher B. GrangerChristopher B. Granger Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC (A.N.V., J.H.A., D.M.W., C.B.G., D.F.K., R.H.M., R.D.L.). Search for more papers by this author , Harald DariusHarald Darius Vivantes Neukoelln Medical Center, Berlin, Germany (H.D.). Search for more papers by this author , Stephan WindeckerStephan Windecker Department of Cardiology, Inselspital, Bern University Hospital, University of Bern, Switzerland (S.W.). Search for more papers by this author , Roxana MehranRoxana Mehran Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, and Cardiovascular Research Foundation, New York (R.M.). Search for more papers by this author , Oleg AverkovOleg Averkov Pirogov Russian National Research Medical University, Moscow (O.A.). Search for more papers by this author , Andrzej BudajAndrzej Budaj Department of Cardiology, Grochowski Hospital, Warsaw, Poland (A.B.). Search for more papers by this author , David F. KongDavid F. Kong Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC (A.N.V., J.H.A., D.M.W., C.B.G., D.F.K., R.H.M., R.D.L.). Search for more papers by this author , Zhanna KobalavaZhanna Kobalava RUDN University, Moscow, Russia (Z.K.). Search for more papers by this author , Rajendra H. MehtaRajendra H. Mehta Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC (A.N.V., J.H.A., D.M.W., C.B.G., D.F.K., R.H.M., R.D.L.). Search for more papers by this author , Zulfiqar MirzaZulfiqar Mirza Witham Specialist Center, Lebanon, IN (Z.M.). Search for more papers by this author , Patricia Oliveira GuimaraesPatricia Oliveira Guimaraes Instituto do Coração–HCFMUSP, São Paulo, Brazil (P.O.G.). Search for more papers by this author , Alexander ParkhomenkoAlexander Parkhomenko Emergency Cardiology Department, Institute of Cardiology, Kiev, Ukraine (A.P.). Search for more papers by this author , Alexandre QuadrosAlexandre Quadros Instituto de Cardiologia do Rio Grande do Sul, Porto Alegre, Brazil (A.Q.). Search for more papers by this author , Holger ThieleHolger Thiele Heart Center Leipzig at University of Leipzig, Germany (H.T.). Search for more papers by this author , Shaun G. GoodmanShaun G. Goodman Canadian VIGOUR Center, University of Alberta, Edmonton (S.G.G.). Terrence Donnelly Heart Centre, St. Michael’s Hospital, University of Toronto, ON, Canada (S.G.G.). Search for more papers by this author and Renato D. LopesRenato D. Lopes Renato D. Lopes, MD, PhD, MHS, Duke Clinical Research Institute, 200 Morris St, Durham, NC 27701. Email E-mail Address: [email protected]. Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC (A.N.V., J.H.A., D.M.W., C.B.G., D.F.K., R.H.M., R.D.L.). Search for more papers by this author Originally published25 Sep 2019https://doi.org/10.1161/CIRCULATIONAHA.119.043754Circulation. 2019;140:1960–1963Other version(s) of this articleYou are viewing the most recent version of this article. Previous versions: September 25, 2019: Ahead of Print The optimal antithrombotic therapy among patients with atrial fibrillation who present with acute coronary syndrome (ACS) or require percutaneous coronary intervention (PCI) can be challenging, with combination therapy, including both dual antiplatelet therapy and oral anticoagulation, markedly increasing bleeding risk.1 Recent trials with rivaroxaban2 and dabigatran3 have demonstrated the safety of using a non–vitamin K oral anticoagulant with a P2Y12 inhibitor, without aspirin or with reduced-dose aspirin, after PCI. The AUGUSTUS trial (Aspirin Placebo in Patients With Atrial Fibrillation and Acute Coronary Syndrome or Percutaneous Coronary Intervention) demonstrated that apixaban resulted in less bleeding than vitamin K antagonist (VKA), with lower rates of the composite of death or all-cause hospitalization.4 Rates of bleeding were higher among patients treated with aspirin than those treated with placebo, but rates of death or all-cause hospitalization were not different. This analysis evaluated rates and causes of hospitalization, a key secondary outcome, overall and by randomized treatment.The rationale and design of the AUGUSTUS trial have been published.5 Briefly, AUGUSTUS was a prospective, multicenter, 2×2 factorial trial that randomized patients with atrial fibrillation and recent ACS or PCI to apixaban or VKA and to aspirin or placebo for 6 months on background P2Y12 inhibitor. The primary end point for the study was major or clinically relevant nonmajor bleeding as defined by the International Society on Thrombosis and Haemostasis. Hospitalizations were classified as cardiovascular, bleeding related, or other cause by reviewers blinded to treatment assignment. The trial protocol was approved by appropriate ethics committees at participating sites, and all patients provided written informed consent before participation in the study.All patients randomized are included and analyzed according to the intent-to-treat principle. Events were counted from the time of randomization through the 6-month visit. Hazard ratios were derived from Cox proportional hazard models using the time to the first cause-specific hospitalization. The incidence of myocardial infarction, International Society on Thrombosis and Haemostasis major bleeding, and all-cause death after bleeding-related hospitalizations are reported as frequencies and percentages of patients in patients discharged alive. Bleeding-related hospitalizations occurring within 7 days after another hospitalization are excluded from this analysis.A total of 4614 patients from 492 sites in 33 countries were randomized. The median age was 71 years, and 29% were women. Thirty-seven percent had an ACS and underwent PCI; 24% had medically managed ACS; and the remaining 39% underwent elective PCI. The mean CHA2DS2-VASc score was 3.9 (SD, 1.6), and the mean HAS-BLED score was 2.9 (SD, 0.9). Clopidogrel was the P2Y12 inhibitor of choice in 93% of patients.A total of 1125 patients (24.4%) were hospitalized during the study duration, and the median time from randomization to the first hospitalization was 46 days (25th–75th percentiles, 19–96 days). Among patients with hospitalizations, the median time in hospital during follow-up was 6 days (3–14 days) with 384 (34.1%) having ≥2 hospitalizations. The median length of hospitalization was 4 days (2–8 days). Among study participants, 780 patients (16.9%) had a least 1 cardiovascular hospitalization, 208 (4.5%) had a least 1 bleeding-related hospitalization, and 359 (7.8%) had at least 1 hospitalization for another cause. Patients who underwent PCI (either elective or resulting from ACS) were more likely to be hospitalized during the study period than those who presented with medically managed ACS.Rates of hospitalization were lower among patients assigned to apixaban than those assigned to VKA (22.5% versus 26.3%; hazard ratio [HR], 0.83 [95% CI, 0.74–0.93]; P=0.002), driven by lower rates of cardiovascular hospitalization (15.4% versus 18.5%; HR, 0.81 [95% CI, 0.71–0.94]) and bleeding-related hospitalization (3.6% versus 5.4%; HR, 0.65 [95% CI, 0.50–0.86]; Figure [A–C]). Rates of hospitalization were not different between patients assigned to aspirin and those assigned to placebo (25.4% versus 23.4%; HR, 1.10 [95% CI, 0.98–1.24]), as were rates of cardiovascular hospitalization (16.8% versus 17.0%; HR 0.99 [95% CI, 0.86–1.14]); however, rates of bleeding-related hospitalization were >2-fold higher in patients assigned to aspirin than in those assigned to placebo (6.1% versus 2.9%; HR, 2.11 [95% CI, 1.58–2.81]; Figure [D–F]).Download figureDownload PowerPointFigure. Hospitalization by anticoagulant or antiplatelet therapy. A, All-cause hospitalization, apixaban vs vitamin K antagonist (VKA). B, Cardiovascular hospitalization, apixaban vs VKA. C, Bleeding-related hospitalization, apixaban vs VKA. D, All-cause hospitalization, aspirin vs placebo. E, Cardiovascular hospitalization, aspirin vs placebo. F, Bleeding-related hospitalization, aspirin vs placebo. HR indicates hazard ratio.This study has some limitations that warrant consideration. Primary causes of hospitalization were provided by the site investigators. Although they were independently classified by physician-reviewers blinded to treatment assignment, primary source documents were not reviewed. The open-label treatment with apixaban and VKA might lead to an unintentional bias to admit a patient treated with VKA compared with apixaban, especially for bleeding or cardiovascular causes. Bias is not expected for the blinded aspirin/placebo comparison, which did not demonstrate an overall difference in hospitalization. However, the increased risk of bleeding with aspirin is reflected by the increase in bleeding-related hospitalizations. Despite potential bias, adjudication of events and classification of hospitalization were blinded to treatment assignment. Finally, this analysis was based on the results of a randomized clinical trial with specific inclusion and exclusion criteria, which, despite being broad, may limit the generalizability of these results to other populations.This prespecified analysis of the AUGUSTUS study demonstrates that the risk of rehospitalization in this patient population remains high, with ≈1 of 4 patients with atrial fibrillation with recent ACS/PCI requiring rehospitalization within 6 months of their ACS or PCI event. The risk of hospitalization was lower among patients treated with apixaban than those treated with VKA, driven by a 35% reduction in bleeding-related hospitalization and a 19% reduction in the much higher rate of cardiovascular hospitalization. Although bleeding-related hospitalization was higher among patients treated with aspirin, there was no difference in all-cause hospitalization between patients assigned to aspirin and those assigned to placebo. Our findings further support the use of apixaban over warfarin and the avoidance of aspirin to reduce bleeding on background P2Y12 inhibitor in this high-risk patient population.Sources of FundingThe AUGUSTUS study was funded by Bristol-Myers Squibb (Princeton, NJ) and Pfizer, Inc (New York, NY).DisclosuresDr Alexander reports research grants from Bristol-Myers Squibb, Boehringer Ingelheim, AstraZeneca, CryoLife, CSL Behring, US Food and Drug Administration, National Institutes of Health, Sanofi, and VoluMetrix, as well as consulting fees from Pfizer, Bristol-Myers Squibb, AbbVie Pharmaceuticals, CSL Behring, Novo Nordisk, Portola Pharmaceuticals, Quantum Genomics, Teikoku Pharmaceuticals, VA Cooperative Studies, and Zafgen. Dr Aronson is an employee of Bristol-Myers Squibb. Dr Granger reports research grants from Bayer, Boehringer Ingelheim, Bristol-Myers Squibb, Daiichi Sankyo, Janssen, Pfizer, Armetheon, AstraZeneca, US Food and Drug Administration, GlaxoSmithKline, The Medicines Company, Medtronic Foundation, Medtronic Inc, and Novartis, as well as consulting fees from Bayer, Boehringer Ingelheim, Boston Scientific, Bristol-Myers Squibb, Daiichi Sankyo, Janssen, Pfizer, Abbvie, Armetheon, AstraZeneca, Eli Lilly, Gilead, GlaxoSmithKline, Hoffmann-La Roche, The Medicines Company, National Institutes of Health, Novartis, Sirtex, Verseon, Apple, Medscape, LLC, Merck, Novo Nordisk, Roche Diagnostics, and Rho Pharmaceuticals. Dr Darius reports personal fees from Bristol-Myers Squibb/Pfizer, Boehringer Ingelheim, Bayer Healthcare, and Daiichi Sankyo. Dr Windecker reports institutional research and educational grants from Abbott, Amgen, Bayer, BMS, CSL Behring, Boston Scientific, Biotronik, Edwards Lifesciences, Medtronic, Polares, and Sinomed. Dr Mehran reports institutional research grants from AstraZeneca, Bayer, Beth Israel Deaconess, Bristol-Myers Squibb/Sanofi, CSL Behring, Eli Lilly/Daiichi Sankyo, Medtronic, Novartis, and OrbusNeich; consulting fees from Boston Scientific, Abbott Vascular, Medscape, Siemens Medical Solutions, Roivant Sciences Inc, and Sanofi; consulting (no fees) to Regeneron Pharmaceuticals Inc; institutional consulting fees from Abbott Vascular, Spectranetics/Phillips/Volcano Corporation, Bristol-Myers Squibb, Novartis, and Watermark Research; serving as an executive committee member for Janssen Pharmaceuticals and Bristol-Myers Squibb; and <1% equity in Claret Medical and Elixir Medical. Dr Averkov reports speaking and consulting fees from AstraZeneca, Bayer, Aspen, Boehringer Ingelheim, Pfizer, Abbott, Servier, Sanofi, Glaxo, SKB, KRKA, Bristol-Myers Squibb, ACINO, The Medicines Company, Raipharm, Novartis, and Lilly. Budaj reports personal fees and nonfinancial support from Bristol-Myers Squibb/Pfizer, Bayer, AstraZeneca, and Sanofi Aventis, as well as personal fees from Eisai, Novartis, and GlaxoSmithKline. Dr Kong reports research grants from Medtronic Vascular Inc, Volcano Corp, OrbusNeich, IBM, and Terumo Medical, plus consulting fees from Novo Nordisk, Allmed Healthcare, and Chiesi USA. Dr Parkhomenko reports personal fees and nonfinancial support from Bristol-Myers Squibb/Pfizer, Bayer, and AstraZeneca, as well as personal fees from Sanofi Aventis, Portola, and Amgen. Dr Quadros reports educational support from Boston Scientific, Terumo Medical, and Biotronik. Dr Goodman reports research grant support and/or speaker/consulting honoraria from Amgen, AstraZeneca, Bayer, Boehringer Ingelheim, Bristol-Myers Squibb, CSL Behring, Daiichi-Sankyo, Eli Lilly, Esperion, Fenix Group International, Ferring Pharmaceuticals, GlaxoSmithKline, HLS Therapeutics, Janssen/Johnson & Johnson, Luitpold Pharmaceuticals, Matrizyme, Merck, Novartis, Novo Nordisk A/C, Pfizer, Regeneron, Sanofi, Servier, Tenax Therapeutics, Heart and Stroke Foundation of Ontario/University of Toronto, Canadian Heart Research Centre and MD Primer, Canadian VIGOUR Centre, Duke Clinical Research Institute, and PERFUSE. Dr Lopes reports research grants from Bristol-Myers Squibb, Pfizer, Amgen, Inc, GlaxoSmithKline, Medtronic PLC, and Sanofi Aventis, as well as consulting fees from Bristol-Myers Squibb, Pfizer, Boehringer Ingelheim, and Bayer AG. The other authors report no conflicts.FootnotesData Sharing: The data, analytical methods, and study materials will not be made available to other researchers for purposes of reproducing the results or replicating the procedure.Clinical Trial Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT02415400.https://www.ahajournals.org/journal/circRenato D. Lopes, MD, PhD, MHS, Duke Clinical Research Institute, 200 Morris St, Durham, NC 27701. Email renato.[email protected]edu.References1. Lopes RD, Rao M, Simon DN, Thomas L, Ansell J, Fonarow GC, Gersh BJ, Go AS, Hylek EM, Kowey P, et al. Triple vs dual antithrombotic therapy in patients with atrial fibrillation and coronary artery disease.Am J Med. 2016; 129:592–599.e1. doi: 10.1016/j.amjmed.2015.12.026CrossrefMedlineGoogle Scholar2. Gibson CM, Mehran R, Bode C, Halperin J, Verheugt FW, Wildgoose P, Birmingham M, Ianus J, Burton P, van Eickels M, et al. Prevention of bleeding in patients with atrial fibrillation undergoing PCI.N Engl J Med. 2016; 375:2423–2434. doi: 10.1056/NEJMoa1611594CrossrefMedlineGoogle Scholar3. Cannon CP, Bhatt DL, Oldgren J, Lip GYH, Ellis SG, Kimura T, Maeng M, Merkely B, Zeymer U, Gropper S, et al; RE-DUAL PCI Steering Committee and Investigators. Dual antithrombotic therapy with dabigatran after PCI in atrial fibrillation.N Engl J Med. 2017; 377:1513–1524. doi: 10.1056/NEJMoa1708454CrossrefMedlineGoogle Scholar4. Lopes RD, Heizer G, Aronson R, Vora AN, Massaro T, Mehran R, Goodman SG, Windecker S, Darius H, Li J, et al; AUGUSTUS Investigators. Antithrombotic therapy after acute coronary syndrome or PCI in atrial fibrillation.N Engl J Med. 2019; 380:1509–1524. doi: 10.1056/NEJMoa1817083CrossrefMedlineGoogle Scholar5. Lopes RD, Vora AN, Liaw D, Granger CB, Darius H, Goodman SG, Mehran R, Windecker S, Alexander JH. An open-label, 2 × 2 factorial, randomized controlled trial to evaluate the safety of apixaban vs. vitamin K antagonist and aspirin vs. placebo in patients with atrial fibrillation and acute coronary syndrome and/or percutaneous coronary intervention: rationale and design of the AUGUSTUS trial.Am Heart J. 2018; 200:17–23. doi: 10.1016/j.ahj.2018.03.001MedlineGoogle Scholar Previous Back to top Next FiguresReferencesRelatedDetailsCited By Krishnakumar H, Mascitelli J, Hassan A, Leary J and Son C (2022) Treatment of cerebral aneurysms with flow diversion or stent assisted coiling in patients on concurrent oral anticoagulation, The Neuroradiology Journal, 10.1177/19714009221114443, (197140092211144) Zhang L, Tian Y, Ren H, Zhu A, Dong L, Wang X, Han X and Chen G (2022) Effect of PCI Standardized Telephone Follow-Up Service Mode on Out-of-Hospital Complications, Rehospitalization Rate, and Quality of Life of Discharged Patients with Acute Coronary Syndrome after PCI, Computational and Mathematical Methods in Medicine, 10.1155/2022/4319887, 2022, (1-7), Online publication date: 21-Jul-2022. Nishikawa T, Morishima T, Fujii Y, Okawa S, Otsuka T, Kamada R, Yasui T, Shioyama W, Oka T, Tabuchi T and Fujita M (2021) Prognostic Impact of Cancer Activity on Clinically Relevant Bleeding Events After Percutaneous Coronary Intervention, The Journal of Medical Investigation, 10.2152/jmi.68.29, 68:1.2, (29-37), . Yavelov I (2020) Apixaban in non-valvular atrial fibrillation and treatment of venous thromboembolism: universal safety advantage in different categories of patients, Meditsinskiy sovet = Medical Council, 10.21518/2079-701X-2020-14-48-54:14, (48-54) Pavlova T, Duplyakova P, Shkaeva O and Krivova S (2020) Subanalysis of the AUGUSTUS trial, Russian Journal of Cardiology, 10.15829/1560-4071-2020-4104, 25, (4104) Alexander J, Wojdyla D, Vora A, Thomas L, Granger C, Goodman S, Aronson R, Windecker S, Mehran R and Lopes R (2020) Risk/Benefit Tradeoff of Antithrombotic Therapy in Patients With Atrial Fibrillation Early and Late After an Acute Coronary Syndrome or Percutaneous Coronary Intervention, Circulation, 141:20, (1618-1627), Online publication date: 19-May-2020. December 3, 2019Vol 140, Issue 23 Advertisement Article InformationMetrics © 2019 American Heart Association, Inc.https://doi.org/10.1161/CIRCULATIONAHA.119.043754PMID: 31553201 Originally publishedSeptember 25, 2019 Keywordsatrial fibrillationplatelet aggregation inhibitorshospitalizationacute coronary syndromeanticoagulantspercutaneous coronary interventionPDF download Advertisement SubjectsAcute Coronary SyndromesAnticoagulantsPercutaneous Coronary Intervention" @default.
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