title: Effectiveness and safety of rivaroxaban therapy in daily-care patients with atrial fibrillation. Results from the Dresden NOAC Registry.
abstract: The effectiveness and safety of rivaroxaban for stroke prevention in atrial fibrillation (SPAF) demonstrated in ROCKET AF needs to be confirmed in daily care. To evaluate effectiveness and safety of rivaroxaban therapy in SPAF patients in daily care, we used data from an ongoing, prospective, non-interventional registry of more than 2700 patients on novel oral anticoagulants in daily care. Between October 1, 2011 and February 28, 2013, a total of 1204 SPAF patients receiving rivaroxaban were enrolled. During a mean follow-up of 796.2 ± 207.3 days, the combined endpoint of stroke/transient ischaemic attack/systemic embolism occurred at a rate of 2.03/100 patient-years in the intention-to-treat analysis (95 % confidence interval [CI] 1.5-2.7) and at 1.7/100 patient-years in the on-treatment analysis (events within 3 days after last intake). On-treatment rates were higher in patients selected for 15 mg rivaroxaban (n=384) once daily [OD] compared with the 820 patients selected for 20 mg OD (2.7 [95 % CI 1.6-4.2] vs 1.25/100 patient-years [95 % CI 0.8-1.9]). On treatment, major bleeding occurred at a rate of 3.0/100 patient-years and significantly more often in patients receiving the 15 mg OD dose compared with the 20 mg OD dose (4.5 vs 2.4/100 patient-years). Rivaroxaban treatment discontinuation occurred in a total of 277 patients during follow-up (12.0/100 patient-years in Kaplan-Meier analysis). Our data contribute to the confirmation of effectiveness and relative safety of rivaroxaban in daily-care patients. Furthermore, rivaroxaban discontinuation rates were considerably lower than those reported for vitamin K antagonists.
authors.forename: Judith
authors.initials: J
authors.lastname: Hecker
authors.forename: Sandra
authors.initials: S
authors.lastname: Marten
authors.forename: Loretta
authors.initials: L
authors.lastname: Keller
authors.forename: Sindy
authors.initials: S
authors.lastname: Helmert
authors.forename: Franziska
authors.initials: F
authors.lastname: Michalski
authors.forename: Sebastian
authors.initials: S
authors.lastname: Werth
authors.forename: Kurtulus
authors.initials: K
authors.lastname: Sahin
authors.forename: Luise
authors.initials: L
authors.lastname: Tittl
authors.affiliation: Jan Beyer-Westendorf, MD, Head of "Thrombosis Research"; Center for Vascular Medicine, University Hospital "Carl Gustav Carus", Technical University Dresden, Fetscherstrasse 74; 01307 Dresden, Germany, E-mail: jan.beyer@uniklinikum-dresden.de.
authors.forename: Jan
authors.initials: J
authors.lastname: Beyer-Westendorf
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000925:Anticoagulants / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D001281:Atrial Fibrillation / Q000150:complications / Q000188:drug therapy*; D015331:Cohort Studies; D004617:Embolism / Q000517:prevention & control; D005260:Female; D005858:Germany; D006470:Hemorrhage / Q000139:chemically induced; D006801:Humans; D002546:Ischemic Attack, Transient / Q000517:prevention & control; D053208:Kaplan-Meier Estimate; D008297:Male; D011446:Prospective Studies; D012042:Registries; D000069552:Rivaroxaban / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D012449:Safety; D020521:Stroke / Q000517:prevention & control; D016896:Treatment Outcome
chemical_list: D000925:Anticoagulants; D000069552:Rivaroxaban
keywords: Anticoagulation; atrial fibrillation; bleeding; persistence; rivaroxaban