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The EMA indication is for patients with non-valvular AF with at least one risk factor, namely: previous stroke, transient ischaemic attack (TIA) or systemic embolism; LVEF<40%; symptomatic heart failure; and age ≥75 years or age ≥65 years with one of the following: diabetes, coronary artery disease or hypertension.

The FDA has approved the 150 mg b.i.d. dose, and the 75 mg b.i.d. dose in severe renal impairment, while the EMA has approved both the 110 mg b.i.d. and 150 mg b.i.d. doses.

D150 was superior to wafarin, but increased significantly GI bleeding.

D110 was non-inferior to wafarin.

Rates of haemorrhagic stroke and ICH were lower with both doses of dabigatran. There was a significant reduction in ischaemic stroke and all-cause mortality, vascular mortality.

The rates of discontinuation were higher with D150 (20.7%) and D110 (21.2%), compared with 16.6% with warfarin at 2 years.

Patients aged > 75 years had rates of major bleeding similar to warfarin with D110, with a trend towards more bleeding with D150.

Previous VKA exposure does not inﬂuence the beneﬁts of dabigatran at either dose, compared with warfarin.

The concerns over the small increase were in MI with dabigatran. A meta-analysis of seven dabigatran studies (AF, venous thromboembolism, etc.) in over 30 000 patients showed a significant 33% increase in MI, but an 11% reduction in all-cause mortality, when dabigatran was compared to warfarin. However, this may reflect a better protective effect of warfarin against MI.

ESC guideline

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