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.
BACKGROUND
There is a modest risk of myocardial infarction (MI) and myocardial ischemic events in patients with atrial fibrillation.


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.
Division of Clinical Electrophysiology, J.W. Goethe University Hospital, Theodor-Stern-Kai 7, Frankfurt, Germany. Hohnloser@em.uni-frankfurt.de
Stefan H
SH
Hohnloser
Jonas
J
Oldgren
Sean
S
Yang
Lars
L
Wallentin
Michael
M
Ezekowitz
Paul
P
Reilly
John
J
Eikelboom
Martina
M
Brueckmann
Salim
S
Yusuf
Stuart J
SJ
Connolly
D000368:Aged; D000369:Aged, 80 and over; D000789:Angina, Unstable / Q000453:epidemiology; D000925:Anticoagulants / Q000009:adverse effects / Q000627:therapeutic use; D000991:Antithrombins / Q000009:adverse effects / Q000627:therapeutic use; D001281:Atrial Fibrillation / Q000150:complications* / Q000188:drug therapy*; D001562:Benzimidazoles / Q000009:adverse effects / Q000627:therapeutic use*; D000069604:Dabigatran; D016757:Death, Sudden, Cardiac / Q000453:epidemiology; D004305:Dose-Response Relationship, Drug; D005260:Female; D006323:Heart Arrest / Q000453:epidemiology; D006801:Humans; D015994:Incidence; D008297:Male; D008875:Middle Aged; D017202:Myocardial Ischemia / Q000453:epidemiology*; D012307:Risk Factors; D016037:Single-Blind Method; D014859:Warfarin / Q000009:adverse effects / Q000627:therapeutic use*; D015091:beta-Alanine / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use
D000925:Anticoagulants; D000991:Antithrombins; D001562:Benzimidazoles; D015091:beta-Alanine; D014859:Warfarin; D000069604:Dabigatran