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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
S. Windecker, RD. Lopes, T. Massaro, C. Jones-Burton, CB. Granger, R. Aronson, G. Heizer, SG. Goodman, H. Darius, WS. Jones, M. Aschermann, D. Brieger, F. Cura, T. Engstrøm, V. Fridrich, S. Halvorsen, K. Huber, HJ. Kang, JL. Leiva-Pons, BS....
Jazyk angličtina Země Spojené státy americké
Typ dokumentu klinické zkoušky, klinické zkoušky, fáze IV, srovnávací studie, časopisecké články, multicentrická studie, randomizované kontrolované studie, práce podpořená grantem
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- MeSH
- akutní koronární syndrom komplikace farmakoterapie chirurgie MeSH
- antagonisté purinergních receptorů P2Y škodlivé účinky terapeutické užití MeSH
- antikoagulancia škodlivé účinky terapeutické užití MeSH
- Aspirin terapeutické užití MeSH
- elektivní chirurgické výkony MeSH
- fibrilace síní komplikace farmakoterapie MeSH
- fibrinolytika škodlivé účinky terapeutické užití MeSH
- hospitalizace MeSH
- inhibitory agregace trombocytů škodlivé účinky terapeutické užití MeSH
- kardiovaskulární látky terapeutické užití MeSH
- kombinovaná farmakoterapie MeSH
- kombinovaná terapie MeSH
- koronární angioplastika * MeSH
- krvácení chemicky indukované epidemiologie MeSH
- lidé středního věku MeSH
- lidé MeSH
- management nemoci MeSH
- proporcionální rizikové modely MeSH
- prospektivní studie MeSH
- pyrazoly terapeutické užití MeSH
- pyridony terapeutické užití MeSH
- senioři MeSH
- vitamin K antagonisté a inhibitory MeSH
- výsledek terapie MeSH
- Check Tag
- lidé středního věku MeSH
- lidé MeSH
- mužské pohlaví MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- klinické zkoušky, fáze IV MeSH
- klinické zkoušky MeSH
- multicentrická studie MeSH
- práce podpořená grantem MeSH
- randomizované kontrolované studie MeSH
- srovnávací studie MeSH
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]; Pinteraction=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 (Pinteraction=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]; Pinteraction=0.479). For the same comparison, there was no difference in outcomes among the 3 groups for the composite of death or hospitalization (Pinteraction=0.787) and death and ischemic events (Pinteraction=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.
Bristol Myers Squibb Lawrenceville NJ
Canadian VIGOUR Center University of Alberta Edmonton Canada
Cardiovascular Clinical Research Institute Lady Davis Carmel Medical Center Haifa Israel
Charles University Prague Czech Republic
Concord Clinical School ANZAC Research Institute University of Sydney Australia
CONEVID School of Medicine Universidad Peruana Cayetano Heredia Lima Peru
Department of Cardiology Inselspital Bern University Hospital University of Bern Switzerland
Duke Clinical Research Institute Duke University School of Medicine Durham NC
German Center for Cardiovascular Research
Hospital Central Dr Ignacio Morones Prieto San Luis Potosi Mexico
Hospital de Santo André Leiria Portugal
Instituto Cardiovascular de Buenos Aires and Sanatorio Anchorena Argentina
National Institute of Cardiovascular Diseases Bratislava Slovakia
Oslo University Hospital Ulleval University of Oslo Norway
Rigshospital University of Copenhagen Denmark
School of Medicine Belgrade University Serbia
Semmelweis University Heart and Vascular Center Budapest Hungary
Seoul National University Hospital Seoul National University Korea
St John's Medical College and Research Institute Bangalore India
University Heart Centre Lübeck University Hospital Schleswig Holstein Germany
University Hospital Jean Minjoz Besançon France
University Hospital St Anna Sofia Bulgaria
University of Zagreb School of Medicine University Hospital Centre Croatia
Vivantes Neukoelln Medical Center Berlin Germany
Wilhelminenhospital and Sigmund Freud University Medical School Vienna Austria
Citace poskytuje Crossref.org
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- $a Windecker, Stephan $u Department of Cardiology, Inselspital, Bern University Hospital, University of Bern, Switzerland (S.W.).
- 245 10
- $a 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 / $c S. Windecker, RD. Lopes, T. Massaro, C. Jones-Burton, CB. Granger, R. Aronson, G. Heizer, SG. Goodman, H. Darius, WS. Jones, M. Aschermann, D. Brieger, F. Cura, T. Engstrøm, V. Fridrich, S. Halvorsen, K. Huber, HJ. Kang, JL. Leiva-Pons, BS. Lewis, G. Malaga, N. Meneveau, B. Merkely, D. Milicic, J. Morais, TS. Potpara, D. Raev, M. Sabaté, S. de Waha-Thiele, RC. Welsh, D. Xavier, R. Mehran, JH. Alexander, AUGUSTUS Investigators,
- 520 9_
- $a 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]; Pinteraction=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 (Pinteraction=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]; Pinteraction=0.479). For the same comparison, there was no difference in outcomes among the 3 groups for the composite of death or hospitalization (Pinteraction=0.787) and death and ischemic events (Pinteraction=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.
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- 700 1_
- $a Lopes, Renato D $u 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.).
- 700 1_
- $a Massaro, Tyler $u 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.).
- 700 1_
- $a Jones-Burton, Charlotte $u Bristol-Myers Squibb, Lawrenceville, NJ (C.J.-B., R.A.).
- 700 1_
- $a Granger, Christopher B $u 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.).
- 700 1_
- $a Aronson, Ronald $u Bristol-Myers Squibb, Lawrenceville, NJ (C.J.-B., R.A.).
- 700 1_
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- 700 1_
- $a Goodman, Shaun G $u 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.).
- 700 1_
- $a Darius, Harald $u Vivantes Neukoelln Medical Center, Berlin, Germany (H.D.).
- 700 1_
- $a Jones, W Schuyler $u 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.).
- 700 1_
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- 700 1_
- $a Brieger, David $u Concord Clinical School, ANZAC Research Institute, University of Sydney, Australia (D.B.).
- 700 1_
- $a Cura, Fernando $u Instituto Cardiovascular de Buenos Aires and Sanatorio Anchorena, Argentina (F.C.).
- 700 1_
- $a Engstrøm, Thomas $u Rigshospital, University of Copenhagen, Denmark (T.E.).
- 700 1_
- $a Fridrich, Viliam $u National Institute of Cardiovascular Diseases, Bratislava, Slovakia (V.F.).
- 700 1_
- $a Halvorsen, Sigrun $u Oslo University Hospital Ulleval, University of Oslo, Norway (S.H.).
- 700 1_
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- 700 1_
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- 700 1_
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- 700 1_
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- 700 1_
- $a Malaga, German $u CONEVID School of Medicine, Universidad Peruana Cayetano Heredia, Lima, Peru (G.M.).
- 700 1_
- $a Meneveau, Nicolas $u University Hospital Jean Minjoz, Besançon, France (N.M.). EA3920, University of Burgundy Franche-Comté, Besançon, France (N.M.).
- 700 1_
- $a Merkely, Bela $u Semmelweis University Heart and Vascular Center, Budapest, Hungary (B.M.).
- 700 1_
- $a Milicic, Davor $u University of Zagreb School of Medicine, University Hospital Centre, Croatia (D.M.).
- 700 1_
- $a Morais, João $u Hospital de Santo André, Leiria, Portugal (J.M.).
- 700 1_
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- 700 1_
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- 700 1_
- $a Sabaté, Manel $u University Heart Centre Lübeck, University Hospital Schleswig-Holstein, Germany (S.d.W.-T.).
- 700 1_
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- 700 1_
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- 700 1_
- $a Xavier, Denis $u St John's Medical College and Research Institute, Bangalore, India (D.X.).
- 700 1_
- $a Mehran, Roxana $u Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, and Cardiovascular Research Foundation, New York, NY (R.M.).
- 700 1_
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