The RE-LY study compared dabigatran in the dose of 150 mg and 110 mg twice daily, without laboratory monitoring, with the conventional treatment with warfarin dosed according to INR in 18,113 patients with non-valvular atrial fibrillation and high risk of embolisation. The incidence of cerebrovascular events and systemic embolisation was 1.69% per year in the warfarin group, compared to 1.53% per year in the 110 mg dabigatran group (relative risk 0.91; 95% CI 0.74-1.11; p < 0.001 for non-inferiority) and 1.11% per year in the 150 mg dabigatran (relative risk 0.66; 95% CI 0.53-0.82; p < 0.001 for superiority). Major bleeding occurred in 3.36% of patients per year in the warfarin group, compared to 2.71% of patients per year in the 110 mg dabigatran group (p = 0.003) and 3.11% of patients per year in the 150 mg dabigatran group (p = 0.31). Cerebral haemorrhagic events occurred in 0.38% of patients on warfarin per year, compared to 0.12% per year in the 110 mg dabigatran group (p < 0.001) and 0.10% per year in the 150 mg dabigatran group (p < 0.001). Mortality was 4.13% per year in the warfarin group, compared to 3.75% per year in patients on 110 mg dabigatran (p = 0.13) and 3.64% per year in patients on 150mg dabigatran (p = 0.051). In conclusion, administration of dabigatran to patients with atrial fibrillation in the dose of 110 mg in the RE-LY study was associated with the same incidence of cerebrovascular events and systemic embolisations as with warfarin, while there was lower incidence of major bleeding complications. Dabigatran in the dose of 150mg compared to warfarin led to reduction in the incidence of cerebral events and systemic embolisations with the same incidence of haemorrhagic complications.

1 interní klinika Lékarské fakulty UK a FN Hradec Králové

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