OBJECTIVES: The aim of the ENGEL 2 study was to compare effectiveness, risk and medical costs of dabigatran versus vitamin-K antagonists (VKA) for non-valvular (NV) atrial fibrillation (AF) in real-life setting.

METHODS: All new users of anticoagulant for NVAF in 2013 were identified and followed for 1 year in the SNIIRAM, the French nationwide claims database. NVAF patients were those with long-term disease registration or diagnosis of hospitalisation for AF, without valvular disease history. Patients treated with dabigatran were 1:1 matched with those treated with VKA, on gender, age, date of the first anticoagulant dispensing, and high-dimensional propensity score, including major arterial thrombosis and bleeding risk factors. The 4 main outcomes were hospitalisation with primary diagnosis for i) clinically relevant bleeding, ii) arterial thrombotic event, iii) acute coronary syndrome, and iv) death. Relative risk (RR) was estimated using Cox proportional hazard risk model during drug exposure. Medical costs were calculated from the collective perspective for the same period.

RESULTS: Among the 103,101 new anticoagulant users treated for NVAF in 2013, 20,489 patients with dabigatran were matched to the same number of patients with VKA. The risk of each main outcome was significantly lower for dabigatran compared to VKA, with 29% less events for the composite of the 4 outcomes (RR = 0.71, CI95%: 0.66 to 0.76). The mean cost per patient was higher for anticoagulants and AF drugs (€637 vs €94), but lower for lab tests (€162 vs €384), nursing procedures (€450 vs 702€), medical visits (€722 vs €768), transportation (€177 vs €247), cardiovascular hospitalisations (€1,649 vs €2,058), and at the end for total medical cost (€6,747 vs €8,009).

CONCLUSIONS: The study shows that dabigatran for NVAF is cost-saving compared to VKA due to its better benefit-risk in real-life setting with a 16% lower medical cost for the collective perspective.