In clinical trials new oral
anticoagulants (
NOAC) have proved to be as effective as
warfarin for thromboprophylaxis in
atrial fibrillation. The aim of this study was to evaluate the efficacy and safety of these drugs in clinical practise.
METHODS AND RESULTS: All patients treated with new oral
anticoagulants at Skåne University hospital and Halland County Hospital Halmstad between 2009 and September 2013 was identified in the Swedish national quality registry for
atrial fibrillation and anticoagulation (AuriculA). Medical records were reviewed to identify
thromboembolism and major
bleeding and compared to a
warfarin cohort with a time in therapeutic range (TTR) of 76%. There were 826 patients, mean age 70.6, follow up 591 years, with
atrial fibrillation treated with
NOAC.
Dabigatran was the initial
drug in 79% of the cohort. The incidences of
ischemic stroke/ TIA and major
bleeding were 1.9 (95% CI; 1.0-3.2) and 2.0 (95% CI; 1.1-3.5) per 100 patient-years respectively. The corresponding incidences for
warfarin were 1.5 (95% CI; 1.0-2.2) and 2.5 (95% CI; 1.8-3.3), with no statistical significance between the groups. Two
subdural hematomas occurred 0.4 (95% CI; 0.06-1.1) per 100 patient-years. Mean age of patients with complications was 77.9 (±5.9) and 69.3 (±11.3) for those without (p < 0.001). The discontinuation rate was 6.5% and 1.7% was due to
dyspepsia for
dabigatran, lower than the RE-LY trial.
CONCLUSION: This study, largely based on
dabigatran shows that treatment is efficient and safe in everyday clinical practice and not significantly different compared to a
warfarin cohort with tight anticoagulation control.