Effectiveness and safety of oral anticoagulation treatment with acenocoumarol in non-valvular atrial fibrillation

Abstract

Background: Vitamin K antagonists significantly decrease the incidence of stroke but increase the risk of bleeding. Aim: To assess the effectiveness and risk of bleeding of vitamin K antagonists in non-valvular atrial fibrillation. Material and methods: Retrospective cohort study of 524 patients, 236 women (45%) and 288 men (55%) with non-valvular atrial fibrillation (NVAF) admitted to the oral anticoagulation treatment (OAT) clinic at four public hospitals, between 2009 and 2012. They were followed until March 2013, measuring the quality of OAT, ischemic and bleeding events. Results: The mean follow-up was 26.1 months, with 1154.7 person-years of follow-up accrued. The percentage of time in therapeutic range (TTR) was 35.2 ± 18 %; this was deemed to represent the quality of OAT. The cumulative incidence of ischemic events, either stroke or systemic embolism, was 2.25/100 person-years, being greater in patients with previous embolism (Risk ratio 5.21, 95% confidence intervals 2.31– 11.73, p <0.01). The cumulative incidence of major bleeding events -extracranial and intracraneal- was 4.08/100 person-years. The main site of extracranial major bleeding was the gastrointestinal tract (32%). Conclusions: In our clinical practice, the effectiveness of OAT with acenocoumarol in NVAF patients is similar to that published abroad. However, the incidence of bleeding complications is higher. The quality of the OAT measured by the TTR was lower than abroad.