Effectiveness and safety of 110 or 150 mg dabigatran versus vitamin K antagonists in non‐valvular atrial fibrillation.

Abstract

Background

We compared the 1‐year safety and effectiveness of dabigatran 110 mg (D110) or 150 mg (D150) to vitamin K antagonists (VKA) in patients with non‐valvular atrial fibrillation (NVAF),

Methods

New user cohort study of patients dispensed D110 or D150 vs. VKA in 2013 for NVAF, followed 1 year in the French Système National des Données de Santé (SNDS, 66 million persons). D110 and D150 users were matched 1:1 with VKA users on sex, age, date of first drug dispensing, and high‐dimensional propensity score (hdPS). Hazard ratios (HR [95% confidence intervals]) for stroke and systemic embolism (SSE), major bleeding (MB), and death were computed using Cox proportional hazards or Fine and Gray models during exposure.

Results

In 14,442 matched D110 and VKA patients, mean age 79, 49% male, 91% with CHA₂DS₂‐VASc ≥2 and 8% with HAS‐BLED >3, incidence rates of SSE were 1.9% and 2.6% person‐years (HR 0.69 [0.56‐0.84]), MB 1.8% and 2.9% (0.62 [0.51‐0.76]), death 7.2% and 8.6% (0.84 [0.76‐0.94]). In 8,389 matched D150 and VKA patients, mean age 67, 67% male, 65% with CHA₂DS₂‐VASC ≥ 2; < 5% HAS‐BLED > 3, incidence rates were for SSE 1.4% and 1.9% (0.76 [0.56‐1.04]), MB 0.6 % and 1.9% (0.30 [0.20‐0.46]), death 1.6% and 3.6% (0.46 [0.35‐0.59]). Numbers needed to treat to observe one fewer death were 78 for D110, 88 for D150

Conclusion

In real life D110 and D150 were at least as effective and safer than VKA.

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