Rivaroxaban treatment discontinuation rates in patients with nonvalvular atrial fibrillation in Italian clinical practice: RITMUS-AF
Year: 2026
Type: article
Study design: Observational Study
Abstract: Nonadherence to direct oral anticoagulant (DOAC) therapy exposes patients with nonvalvular atrial fibrillation (NVAF) to an increased risk of ischemic stroke and systemic embolism. Nevertheless, approximately 20% of patients discontinue treatment within the first year. In Italy, data on DOAC discontinuation rates are limited, especially in high-risk populations. RITMUS-AF, a prospective, observational cohort study conducted in 31 centers across Italy, investigated rivaroxaban treatment discontinuation in patients with NVAF in routine clinical practice. It included 805 patients aged ≥18 years with NVAF who were newly initiated on rivaroxaban. The primary endpoint was the proportion of patients who discontinued treatment during a 24-month follow-up. Secondary endpoints included the reasons for discontinuation and self-reported adherence to rivaroxaban therapy. At baseline, most patients were oral anticoagulant (OAC)-naïve (n = 599, 74.4%) and had either symptomatic (n = 364, 45.2%) or asymptomatic (n = 441, 54.8%) NVAF. The overall rate of rivaroxaban discontinuation was 8.9 per 100 patient-years (95% CI: 7.1-11.0). The main reasons for discontinuation were adverse events or physician decisions. After 24 months, high adherence was reported in 90.9% of OAC-non-naïve patients and 61.5% of OAC-naïve patients. Forty-six patients (5.7%) experienced bleeding events (with major bleeding events occurring in <0.5% of cases), and one patient (0.1%) had an ischemic stroke. In the RITMUS-AF study, rivaroxaban treatment was associated with a low treatment discontinuation rate, along with high self-reported adherence and a relatively low incidence of ischemic stroke and bleeding events in a high-risk population, findings that may help inform clinical decision-making on the use of rivaroxaban in routine practice.
Source: PLoS ONE
Authors: Carmine Pizzi, Leopoldo Pagliani, Luca Dalle Carbonare, Piergiuseppe Agostoni, Egidio Imbalzano, Gennaro Galasso, Gianni Casella, Nicolò Dasseni, Leonardo De Luca, Italo Porto, Biagio Sassone, Davide Tosarello, Pareen Vora, Claudia Erminero, Giovanni Battista Forleo, Paolo Fusco, Ciro Mauro, Francesco Milone, Gian Piero Perna
Institutions: IRCCS Azienda Ospedliero-Universitaria di Bologna Policlinico di Sant'Orsola, University of Bologna, Istituto Oncologico Veneto, University of Verona, University of Milan, Centro Cardiologico Monzino, University of Messina, University of Salerno, Ospedale Maggiore Carlo Alberto Pizzardi, Azienda USL di Bologna, Azienda Socio Sanitaria Territoriale della Franciacorta, Policlinico San Matteo Fondazione, Ospedale Policlinico San Martino, University of Ferrara, Bayer (Italy), Bayer (Germany), ASST Fatebenefratelli Sacco, Ospedale Antonio Cardarelli, Ospedale Humanitas Gradenigo, Azienda Ospedaliero-Universitaria delle Marche
Language: English
Subfield: Cardiology and Cardiovascular Medicine
Field: Medicine
Domain: Health Sciences
Open Access status: gold
Estimated APC paid: $2,382
Funder: Bayer
OpenAlex ID: W7128717589