title: Risk of myocardial infarction and death in patients with atrial fibrillation treated with dabigatran or vitamin K antagonists. Meta-analysis of observational analyses.
abstract: The safety of dabigatran versus adjusted-dose vitamin K antagonist (VKA) treatment is the subject of debate. We evaluated the risk of myocardial infarction (MI) or mortality in patients with atrial fibrillation (AF) treated in clinical practice with dabigatran or a VKA. We performed a meta-analysis of observational studies that included an adjusted or matched analysis and reported MI, or death in AF patients treated with dabigatran or a VKA. Ten published analyses met the inclusion criteria. Of the 539,559 patients, 17,365 (3 %) patients were on dabigatran 110 mg twice daily (bid), 150,948 (28 %) were on dabigatran 150 mg bid, and 371,246 (69 %) were on VKA. Adjusted risk for MI versus VKA was 0.71 (0.47-1.07; p=0.10) in patients starting oral anticoagulant (OAC) treatment with dabigatran 110 mg, 0.82 (0.71-0.96; p=0.01) in patients starting dabigatran 150 mg, 1.40 (1.04-1.88; p=0.03) in patients switching OAC treatment to dabigatran 110 mg, and 1.28 (0.88-1.87; p=0.19) in patients switching OAC treatment to dabigatran 150 mg, with statistical homogeneity in each subgroup. Risk of death was consistently lower in patients treated with dabigatran 110 mg (HR 0.79; 0.65-0.96; p=0.02) or 150 mg (HR 0.65; 0.57-0.73; p<0.00001) versus VKA. In conclusion, dabigatran use, as currently prescribed in routine practice for AF patients, was associated with a lower risk of MI in OAC-naïve patients treated with dabigatran 150 mg compared with VKA, and a higher risk of MI in patients switching from VKA to dabigatran 110 mg. Risk of death was lower in AF patients treated with either dose of dabigatran versus VKA.
authors: Walid
authors: W
authors: Darwiche
authors: Theodora
authors: T
authors: Bejan-Angoulvant
authors: Denis
authors: D
authors: Angoulvant
authors: Dominique
authors: D
authors: Babuty
authors: Laurent Fauchier, MD, Service de Cardiologie, Centre Hospitalier Universitaire Trousseau, 37044 Tours, France, Tel.: +33 2 47 47 46 50, E-mail: lfau@med.univ-tours.fr.
authors: Laurent
authors: L
authors: Fauchier
mesh_terms: D000925:Anticoagulants / Q000627:therapeutic use; D001281:Atrial Fibrillation / Q000150:complications* / Q000188:drug therapy / Q000401:mortality*; D000069604:Dabigatran / Q000627:therapeutic use*; D006801:Humans; D009203:Myocardial Infarction / Q000209:etiology*; D064887:Observational Studies as Topic; D018570:Risk Assessment; D014812:Vitamin K / Q000037:antagonists & inhibitors*
chemical_list: D000925:Anticoagulants; D014812:Vitamin K; D000069604:Dabigatran
keywords: Atrial fibrillation; dabigatran; myocardial infarction; vitamin K antagonist