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Published on: July 20, 2022
Persistence on apixaban in atrial fibrillation patients: a retrospective multicentre study
Paolo Verdecchia1, Antonio D'Onofrio2, Vincenzo Russo2,3
1Fondazione Umbra Cuore e Ipertensione-ONLUS, Hospital S. Maria della Misericordia, Cardiology, Perugia.
Insights
Real-world data show that apixaban treatment for nonvalvular atrial fibrillation (NVAF) has high persistence and low rates of major bleeding and major events. These findings support the drug
Area of Science:
- Cardiology
- Pharmacology
- Real-world evidence
Background:
- Non-Vitamin K antagonist oral anticoagulants (NOACs) require real-world data for risk-benefit assessment.
- Apixaban is a NOAC used for nonvalvular atrial fibrillation (NVAF).
Purpose of the Study:
- To evaluate treatment persistence with apixaban in NVAF patients.
- To determine the incidence of major bleeding and major adverse events during apixaban therapy.
Main Methods:
- Multicenter retrospective observational study.
- Data from 766 NVAF patients initiating apixaban between January 2014 and March 2016.
- Median follow-up of 339 days.
Main Results:
- Treatment persistence was 83.5%.
- The rate of major bleeding was 1.15 per 100 person-years (cumulative incidence 4.4%).
- The rate of major events was 1.97 per 100 patient-years (cumulative incidence 7.7%).
Conclusions:
- Apixaban treatment in real-world NVAF patients demonstrates high persistence.
- Incidence of major bleeding and major events is comparable to pivotal trial data (ARISTOTLE study).
- Findings support the external validity of apixaban's safety and efficacy profile.
Aims:
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).
Methods:
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.
Results:
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).
Conclusion:
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.
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