All-Cause Mortality and Cardiovascular Outcomes With Non-Vitamin K Oral Anticoagulants Versus Warfarin in Patients With Heart Failure in the Food and Drug Administration Adverse Event Reporting System

Publikation: Bidrag til tidsskrift/Konferencebidrag i tidsskrift /Bidrag til avisTidsskriftartikelForskningpeer review

  • Thomas G von Lueder, Department of Rheumatology and Medical Faculty, Oslo University Hospital and University of Oslo, Oslo, Norway; Norwegian National Advisory Unit on Rheumatic Diseases in Children and Adolescents, Oslo University Hospital, Oslo, Norway.
  • ,
  • Dan Atar, Department of Rheumatology and Medical Faculty, Oslo University Hospital and University of Oslo, Oslo, Norway; Norwegian National Advisory Unit on Rheumatic Diseases in Children and Adolescents, Oslo University Hospital, Oslo, Norway.
  • ,
  • Stefan Agewall, Department of Rheumatology and Medical Faculty, Oslo University Hospital and University of Oslo, Oslo, Norway; Norwegian National Advisory Unit on Rheumatic Diseases in Children and Adolescents, Oslo University Hospital, Oslo, Norway.
  • ,
  • Jesper K Jensen
  • Ingrid Hopper, Monash Med Ctr, Monash University, Monash Heart
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  • Dipak Kotecha, Monash Med Ctr, Monash University, Monash Heart
  • ,
  • Robert J Mentz, From Guy's and St. Thomas' Hospitals, London (A.T.C.); the Department of Medicine, Stanford University, Stanford (R.A.H.), and Portola Pharmaceuticals, South San Francisco (B.L.W., A.G.) - both in California; the Cardiovascular Division, Brigham and Women's Hospital, Harvard Medical School (S.Z.G.), and Beth Israel Deaconess Medical Center (C.M.G.) - both in Boston; the Faculty of Medicine, University of Calgary, Calgary, AB, Canada (R.D.H.); and the Division of Cardiology, Duke University and Duke Clinical Research Institute, Durham, NC (A.F.H.).
  • ,
  • Moo Hyun Kim, Natl Dong Hwa Univ, National Dong Hwa University, Dept Nat Resources & Environm Studies
  • ,
  • Victor L Serebruany, Johns Hopkins Univ Hosp, Johns Hopkins University, Johns Hopkins Medicine, Div Gastroenterol

BACKGROUND: Many patients with heart failure (HF) are treated with warfarin or non-vitamin K oral anticoagulants (NOACs). Randomized outcome-driven comparisons of different anticoagulant strategies in HF are lacking. Data from international, government-mandated registries may be useful in understanding the real-life use of various anticoagulants and how they are linked to outcomes.

STUDY QUESTION: To assess 2015 annual all-cause mortality, myocardial infarction, and stroke rates co-reported for warfarin and NOACs in subjects with and without HF in the US Food and Drug Administration Adverse Event Reporting System (FAERS) database.

STUDY DESIGN: We extracted and examined outcome cases in subjects with HF and on warfarin, dabigatran, rivaroxaban, apixaban, or edoxaban and stratified these according to anticoagulants.

MEASURES AND OUTCOMES: Annual all-cause mortality, myocardial infarction, and stroke in FAERS.

ANALYSIS METHOD: Odds ratio (OR) and χ(Equation is included in full-text article.)for oral anticoagulants from FAERS with and without HF among complete primary reports issued in 2015.

RESULTS: FAERS reported 137,026 HF cases, with death co-reported in 42,942 (31.3%). In total, 11,278 (8.2%) HF patients were treated with anticoagulants, with more prescribed warfarin (n = 8260) than all NOACs combined (n = 3018). Very few reports for edoxaban were available. Warfarin consistently displayed a signal for excess adverse events compared to NOACs: OR (95% confidence interval) for the composite of mortality, myocardial infarction, and stroke were 1.91 (1.76-2.07) versus apixaban, 1.92 (1.81-2.03) versus dabigatran, 4.09 (3.38-4.37) versus rivaroxaban, and 2.64 (2.53-2.76) versus all NOACs combined (all P < 0.001). Warfarin, compared to all NOACs combined, demonstrated higher rates of all-cause mortality [OR = 2.69 (95% confidence interval, 2.49-2.90)], myocardial infarction [5.30 (4.17-6.74)], stroke [OR = 8.85 (6.61-11.84)], and ischemic stroke [OR = 12.73 (8.87-18.27); all P < 0.001].

CONCLUSIONS: Annual 2015 FAERS profiles in HF patients reveal that warfarin was numerically dominant. Warfarin was associated with higher risk of death, myocardial infarction, and stroke compared to NOACs. These observational data provide real-world insight into a potential safety benefit of NOACs over warfarin in the setting of HF.

OriginalsprogEngelsk
TidsskriftAmerican Journal of Therapeutics
Vol/bind26
Nummer6
Sider (fra-til)e671-e678
ISSN1075-2765
DOI
StatusUdgivet - 31 maj 2019

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