학술논문
Antithrombotic Therapy in Patients With Atrial Fibrillation and Acute Coronary Syndrome Treated Medically or With Percutaneous Coronary Intervention or Undergoing Elective Percutaneous Coronary Intervention: Insights From the AUGUSTUS Trial.
Document Type
Academic Journal
Author
Windecker S; Department of Cardiology, Inselspital, Bern University Hospital, University of Bern, Switzerland (S.W.).; Lopes RD; Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC (R.D.L., T.M., C.B.G., G.H., W.S.J., J.H.A.).; Massaro T; Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC (R.D.L., T.M., C.B.G., G.H., W.S.J., J.H.A.).; Jones-Burton C; Bristol-Myers Squibb, Lawrenceville, NJ (C.J.-B., R.A.).; Granger CB; Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC (R.D.L., T.M., C.B.G., G.H., W.S.J., J.H.A.).; Aronson R; Bristol-Myers Squibb, Lawrenceville, NJ (C.J.-B., R.A.).; Heizer G; Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC (R.D.L., T.M., C.B.G., G.H., W.S.J., J.H.A.).; Goodman SG; Canadian VIGOUR Center, University of Alberta, Edmonton, Canada (S.G.G., R.C.W.).; Terrence Donnelly Heart Centre, St Michael's Hospital, University of Toronto, Ontario, Canada (S.G.G.).; Darius H; Vivantes Neukoelln Medical Center, Berlin, Germany (H.D.).; Jones WS; Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC (R.D.L., T.M., C.B.G., G.H., W.S.J., J.H.A.).; Aschermann M; Charles University, Prague, Czech Republic (M.A.).; Brieger D; Concord Clinical School, ANZAC Research Institute, University of Sydney, Australia (D.B.).; Cura F; Instituto Cardiovascular de Buenos Aires and Sanatorio Anchorena, Argentina (F.C.).; Engstrøm T; Rigshospital, University of Copenhagen, Denmark (T.E.).; Fridrich V; National Institute of Cardiovascular Diseases, Bratislava, Slovakia (V.F.).; Halvorsen S; Oslo University Hospital Ulleval, University of Oslo, Norway (S.H.).; Huber K; Wilhelminenhospital and Sigmund Freud University, Medical School, Vienna, Austria (K.H.).; Kang HJ; Seoul National University Hospital, Seoul National University, Korea (H.-J.K.).; Leiva-Pons JL; Hospital Central Dr Ignacio Morones Prieto, San Luis Potosi, Mexico (J.L.L.-P.).; Lewis BS; Cardiovascular Clinical Research Institute, Lady Davis Carmel Medical Center, Haifa, Israel (B.S.L.).; Malaga G; CONEVID School of Medicine, Universidad Peruana Cayetano Heredia, Lima, Peru (G.M.).; Meneveau N; University Hospital Jean Minjoz, Besançon, France (N.M.).; EA3920, University of Burgundy Franche-Comté, Besançon, France (N.M.).; Merkely B; Semmelweis University Heart and Vascular Center, Budapest, Hungary (B.M.).; Milicic D; University of Zagreb School of Medicine, University Hospital Centre, Croatia (D.M.).; Morais J; Hospital de Santo André, Leiria, Portugal (J.M.).; Potpara TS; School of Medicine, Belgrade University, Serbia (T.S.P.).; Clinical Centre of Serbia, Belgrade (T.S.P.).; Raev D; University Hospital St Anna, Sofia, Bulgaria (D.R.).; Sabaté M; University Heart Centre Lübeck, University Hospital Schleswig-Holstein, Germany (S.d.W.-T.).; de Waha-Thiele S; German Center for Cardiovascular Research (DZHK), partner site Hamburg/Kiel/Lübeck, Lübeck (S.d.W.-T.).; Welsh RC; Canadian VIGOUR Center, University of Alberta, Edmonton, Canada (S.G.G., R.C.W.).; Mazankowski Alberta Heart Institute, Edmonton, Canada (R.C.W.).; Xavier D; St John's Medical College and Research Institute, Bangalore, India (D.X.).; Mehran R; Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, and Cardiovascular Research Foundation, New York, NY (R.M.).; Alexander JH; Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC (R.D.L., T.M., C.B.G., G.H., W.S.J., J.H.A.).
Source
Publisher: Lippincott Williams & Wilkins Country of Publication: United States NLM ID: 0147763 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1524-4539 (Electronic) Linking ISSN: 00097322 NLM ISO Abbreviation: Circulation Subsets: MEDLINE
Subject
Language
English
Abstract
Background: The safety and efficacy of antithrombotic regimens may differ between patients with atrial fibrillation who have acute coronary syndromes (ACS), treated medically or with percutaneous coronary intervention (PCI), and those undergoing elective PCI.
Methods: Using a 2×2 factorial design, we compared apixaban with vitamin K antagonists and aspirin with placebo in patients with atrial fibrillation who had ACS or were undergoing PCI and were receiving a P2Y12 inhibitor. We explored bleeding, death and hospitalization, as well as death and ischemic events, by antithrombotic strategy in 3 prespecified subgroups: patients with ACS treated medically, patients with ACS treated with PCI, and those undergoing elective PCI.
Results: Of 4614 patients enrolled, 1097 (23.9%) had ACS treated medically, 1714 (37.3%) had ACS treated with PCI, and 1784 (38.8%) had elective PCI. Apixaban compared with vitamin K antagonist reduced International Society on Thrombosis and Haemostasis major or clinically relevant nonmajor bleeding in patients with ACS treated medically (hazard ratio [HR], 0.44 [95% CI, 0.28-0.68]), patients with ACS treated with PCI (HR, 0.68 [95% CI, 0.52-0.89]), and patients undergoing elective PCI (HR, 0.82 [95% CI, 0.64-1.04]; Pinteraction =0.052) and reduced death or hospitalization in the ACS treated medically (HR, 0.71 [95% CI, 0.54-0.92]), ACS treated with PCI (HR, 0.88 [95% CI, 0.74-1.06]), and elective PCI (HR, 0.87 [95% CI, 0.72-1.04]; P interaction =0.345) groups. Compared with vitamin K antagonists, apixaban resulted in a similar effect on death and ischemic events in the ACS treated medically, ACS treated with PCI, and elective PCI groups ( P interaction =0.356). Aspirin had a higher rate of bleeding than did placebo in patients with ACS treated medically (HR, 1.49 [95% CI, 0.98-2.26]), those with ACS treated with PCI (HR, 2.02 [95% CI, 1.53-2.67]), and those undergoing elective PCI (HR, 1.91 [95% CI, 1.48-2.47]; P interaction =0.479). For the same comparison, there was no difference in outcomes among the 3 groups for the composite of death or hospitalization ( P interaction =0.787) and death and ischemic events ( P interaction =0.710).
Conclusions: An antithrombotic regimen consisting of apixaban and a P2Y12 inhibitor without aspirin provides superior safety and similar efficacy in patients with atrial fibrillation who have ACS, whether managed medically or with PCI, and those undergoing elective PCI compared with regimens that include vitamin K antagonists, aspirin, or both.
Clinical Trial Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT02415400.
Methods: Using a 2×2 factorial design, we compared apixaban with vitamin K antagonists and aspirin with placebo in patients with atrial fibrillation who had ACS or were undergoing PCI and were receiving a P2Y
Results: Of 4614 patients enrolled, 1097 (23.9%) had ACS treated medically, 1714 (37.3%) had ACS treated with PCI, and 1784 (38.8%) had elective PCI. Apixaban compared with vitamin K antagonist reduced International Society on Thrombosis and Haemostasis major or clinically relevant nonmajor bleeding in patients with ACS treated medically (hazard ratio [HR], 0.44 [95% CI, 0.28-0.68]), patients with ACS treated with PCI (HR, 0.68 [95% CI, 0.52-0.89]), and patients undergoing elective PCI (HR, 0.82 [95% CI, 0.64-1.04]; P
Conclusions: An antithrombotic regimen consisting of apixaban and a P2Y
Clinical Trial Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT02415400.