Real-world data on treatment persistence, safety and effectiveness of non-Vitamin K antagonist oral anticoagulants (NOACs) play an important role in the assessment of risks and benefits of these drugs. Our aim was to evaluate persistence on treatment, incidence of major bleeding and incidence of a composite endpoint of major events, including all-cause death, myocardial infarction, stroke and systemic thromboembolism, during treatment with apixaban in a cohort of patients with nonvalvular atrial fibrillation (NVAF).
In this multicentre retrospective observational study, we retrieved data from medical records of five Italian hospitals on patients with a diagnosis of NVAF who initiated apixaban between 1 January 2014 and 31 March 2016 and had a first subsequent visit at the same hospital.
We studied 766 patients with mean age of 74.2 (standard deviation 11.1) years and median CHADS2 and CHA2DS2VASc scores of 2.0 and 4.0, respectively. Over a median follow-up period of 339 days, persistence on treatment was 83.5% [95% confidence interval (95% CI) 75.5–89.1%]. The rate of major bleeding (per 100 person-years) was 1.15 (95% CI 0.39–1.90 per 100 person-years), while the cumulative incidence was 4.4% (95% CI 1.6–12.0). The rate of major events was 1.97 (95% CI 1.08–2.86) per 100 patient-years, with a cumulative incidence over the entire follow-up period of 7.7% (95% CI 4.6–12.8).
In real-life conditions, NVAF patients treated with apixaban show rates of treatment discontinuation and major bleedings, which are comparable to those found in the ARISTOTLE pivotal study, thus supporting its external validity.
aFondazione Umbra Cuore e Ipertensione-ONLUS, Hospital S. Maria della Misericordia, Cardiology, Perugia
bCardiology Department, Ospedale Monaldi, Naples
cDivision of Internal and Cardiovascular Medicine, Department of Medicine, University of Perugia, Perugia
dDepartment of Cardiovascular and Respiratory Sciences, Sapienza University of Rome, Rome
eThrombosis Centre, IRCCS Istituto Clinico Humanitas, Milan
fCardiovascular Centre, Azienda Sanitaria Universitaria Integrata, Trieste
gDepartment of Statistics and Quantitative Methods, University of Milan-Bicocca
hMA Provider, Milan, Italy
Correspondence to Arianna Iorio, Pharmacy, MA Provider, Milan 20123, Italy Tel: +39 02 89096682; e-mail: email@example.com
Received 26 February, 2018
Accepted 19 November, 2018