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Native valve disease in patients with non-valvular atrial fibrillation on warfarin or rivaroxaban
  1. Günter Breithardt1,
  2. Helmut Baumgartner2,
  3. Scott D Berkowitz3,
  4. Anne S Hellkamp4,
  5. Jonathan P Piccini4,
  6. Yuliya Lokhnygina4,
  7. Jonathan L Halperin5,
  8. Daniel E Singer6,
  9. Graeme J Hankey7,
  10. Werner Hacke8,
  11. Richard C Becker9,
  12. Christopher C Nessel10,
  13. Kenneth W Mahaffey11,
  14. Robert M Califf12,
  15. Keith A A Fox13,
  16. Manesh R Patel4
  17. for the ROCKET AF Steering Committee & Investigators
  1. 1Division of Electrophysiology, Department of Cardiovascular Medicine, University Hospital Münster, Münster, Germany
  2. 2Division of Adult Congenital and Valvular Heart Disease, Department of Cardiovascular Medicine, University Hospital Münster, Münster, Germany
  3. 3Bayer Healthcare Pharmaceuticals, L.P., Whippany, New Jersey, USA
  4. 4Duke Clinical Research Institute, Duke University Medical Center, Durham, North Carolina, USA
  5. 5The Cardiovascular Institute, Mount Sinai Medical Center, New York, USA
  6. 6Clinical Epidemiology Unit, Division of General Internal Medicine, Massachusetts General Hospital, and Harvard Medical School, Boston, Massachusetts, USA
  7. 7School of Medicine and Pharmacology, The University of Western Australia, Perth, Australia
  8. 8Ruprecht-Karls-University, Heidelberg, Germany
  9. 9Division of Cardiovascular Health and Disease, Department of Medicine, University of Cincinnati College of Medicine, Cincinnati, Ohio, USA
  10. 10Johnson & Johnson Pharmaceutical Research & Development, Raritan, New Jersey, USA
  11. 11Department of Medicine, Stanford University, Stanford, California, USA
  12. 12Duke Translational Medicine Institute, Duke University Medical Center, Durham, North Carolina, USA
  13. 13University of Edinburgh, and Royal Infirmary of Edinburgh, Edinburgh, UK
  1. Correspondence to Professor Günter Breithardt, Division of Electrophysiology, Department of Cardiovascular Medicine, University Hospital Münster, Münster, Germany; g.breithardt{at}uni-muenster.de

Abstract

Objective To compare the characteristics and outcomes of patients with atrial fibrillation (AF) and aortic stenosis (AS) with patients with AF with mitral regurgitation (MR) or aortic regurgitation (AR) and patients without significant valve disease (no SVD).

Methods Using Rivaroxaban Once-Daily, Oral, Direct Factor Xa Inhibition Compared With Vitamin K Antagonism for Prevention of Stroke and Embolism Trial in Atrial Fibrillation (ROCKET AF) data, we analysed efficacy and safety outcomes, adjusting hazard ratios (HRs) for potential confounders using Cox regression analysis.

Results Among 14 119 intention-to-treat ROCKET AF trial patients, a trial that excluded patients with mitral stenosis or artificial valve prosthesis, 214 had AS with or without other valve abnormalities, 1726 had MR or AR and 12 179 had no SVD. After adjusting for prognostic factors, the composite of stroke, systemic embolism or vascular death increased approximately twofold in patients with AS (AS 10.84, MR or AR 4.54 and no SVD 4.31 events per 100 patient-years, p=0.0001). All-cause death also significantly increased (AS 11.22, MR or AR 4.90 and no SVD 4.39 events per 100 patient-years, p=0.0003). Major bleeding occurred more frequently in AS (adjusted HR 1.61, confidence intervals (CI) 1.03 to 2.49, p<0.05) and MR or AR (HR 1.30, 1.07 to 1.57, p<0.01) than in no SVD, but there was no difference between AS and MR or AR (HR 1.24, 0.78 to 1.97). The relative efficacy of rivaroxaban versus warfarin was consistent among patients with and without valvular disease. Rivaroxaban was associated with higher rates of major bleeding than warfarin in patients with MR or AR (HR 1.63, 1.15 to 2.31).

Conclusions We found that patients with AF and AS on oral anticoagulants may have distinctly different efficacy and safety outcomes than patients with MR or AR or no SVD.

Trial registration number NCT00403767; Post-results.

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