Myocardial Ischemic Events in Patients With Atrial Fibrillation Treated With Dabigatran or Warfarin in the RE-LY (Randomized Evaluation of Long-Term Anticoagulation Therapy) Trial

Author:

Hohnloser Stefan H.1,Oldgren Jonas1,Yang Sean1,Wallentin Lars1,Ezekowitz Michael1,Reilly Paul1,Eikelboom John1,Brueckmann Martina1,Yusuf Salim1,Connolly Stuart J.1

Affiliation:

1. From the Department of Cardiology, J.W. Goethe University, Frankfurt, Germany (S.H.H.); Uppsala Clinical Research Center and Department of Medical Sciences, Uppsala University, Uppsala, Sweden (J.O., L.W.); McMaster University, Population Health Research Institute, Hamilton, Ontario, Canada (S. Yang, J.E., S. Yusuf, S.J.C.); Lankenau Medical Center, Thomas Jefferson Medical College, Wynnewood, PA (M.E.); Boehringer Ingelheim Pharmaceuticals, Ridgefield, CT (P.R.); and Boehringer Ingelheim Pharma...

Abstract

Background— There is a modest risk of myocardial infarction (MI) and myocardial ischemic events in patients with atrial fibrillation. Methods and Results— Data from the RE-LY study (Randomized Evaluation of Long-Term Anticoagulation Therapy) were used to report rates of MI, unstable angina, cardiac arrest, and cardiac death and the prespecified net clinical benefit and treatment effects of dabigatran versus warfarin. MI occurred at annual rates of 0.82% and 0.81% with dabigatran 110 or 150 mg BID compared with 0.64% with warfarin (hazard ratio [HR] 1.29, 95% confidence interval [CI] 0.96–1.75, P =0.09 for dabigatran 110 mg; HR 1.27, 95% CI 0.94–1.71, P =0.12 for dabigatran 150 mg). Annual rates of a composite of MI, unstable angina, cardiac arrest, and cardiac death were 3.16% per year with dabigatran 110 mg, 3.33% per year with dabigatran 150 mg, and 3.41% per year with warfarin (HR versus warfarin 0.93, 95% CI 0.80–1.06, P =0.28 for dabigatran 110 mg and HR 0.98, 95% CI 0.85–1.12, P =0.77 for dabigatran 150 mg). Events prespecified as “net clinical benefit” (all strokes, systemic embolism, MI, pulmonary embolism, major bleeding, and all-cause death) occurred at a rate of 7.34% per year with dabigatran 110 mg, 7.11% per year with dabigatran 150 mg, and 7.91% per year with warfarin (HR 0.92, 95% CI 0.84–1.01, P =0.09 for dabigatran 110 mg and HR 0.90, 95% CI 0.82–0.99, P =0.02 for dabigatran 150 mg). The relative effects of dabigatran versus warfarin on myocardial ischemic events were consistent in patients with or without a baseline history of MI or coronary artery disease. Conclusions— There was a nonsignificant increase in MI with dabigatran compared with warfarin, but other myocardial ischemic events were not increased. Treatment effects of dabigatran were consistent in patients at higher and lower risk of myocardial ischemic events. Clinical Trial Registration— URL: http://www.clinicaltrials.gov . Unique identifier: NCT 00262600.

Publisher

Ovid Technologies (Wolters Kluwer Health)

Subject

Physiology (medical),Cardiology and Cardiovascular Medicine

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