title: Rates, management, and outcome of rivaroxaban bleeding in daily care: results from the Dresden NOAC registry.
abstract: Worldwide, rivaroxaban is increasingly used for stroke prevention in atrial fibrillation and treatment of venous thromboembolism, but little is known about rivaroxaban-related bleeding complications in daily care. Using data from a prospective, noninterventional oral anticoagulation registry of daily care patients (Dresden NOAC registry), we analyzed rates, management, and outcome of rivaroxaban-related bleeding. Between October 1, 2011, and December 31, 2013, 1776 rivaroxaban patients were enrolled. So far, 762 patients (42.9%) reported 1082 bleeding events during/within 3 days after last intake of rivaroxaban (58.9% minor, 35.0% of nonmajor clinically relevant, and 6.1% major bleeding according to International Society on Thrombosis and Haemostasis definition). In case of major bleeding, surgical or interventional treatment was needed in 37.8% and prothrombin complex concentrate in 9.1%. In the time-to-first-event analysis, 100-patient-year rates of major bleeding were 3.1 (95% confidence interval 2.2-4.3) for stroke prevention in atrial fibrillation and 4.1 (95% confidence interval 2.5-6.4) for venous thromboembolism patients, respectively. In the as-treated analysis, case fatality rates of bleeding leading to hospitalizations were 5.1% and 6.3% at days 30 and 90 after bleeding, respectively. Our data indicate that, in real life, rates of rivaroxaban-related major bleeding may be lower and that the outcome may at least not be worse than that of major vitamin K antagonist bleeding, and probably better. This trial was registered at www.clinicaltrials.gov as identifier #NCT01588119.
authors.affiliation: Center for Vascular Medicine and Department of Medicine III, Division of Angiology, and.
authors.forename: Jan
authors.initials: J
authors.lastname: Beyer-Westendorf
authors.affiliation: Center for Vascular Medicine and Department of Medicine III, Division of Angiology, and.
authors.forename: Kati
authors.initials: K
authors.lastname: Förster
authors.affiliation: Department of Medicine I, Division of Gastroenterology, University Hospital "Carl Gustav Carus" Dresden, Dresden, Germany; and.
authors.forename: Sven
authors.initials: S
authors.lastname: Pannach
authors.affiliation: Center for Vascular Medicine and Department of Medicine III, Division of Angiology, and.
authors.forename: Franziska
authors.initials: F
authors.lastname: Ebertz
authors.affiliation: Center for Vascular Medicine and Department of Medicine III, Division of Angiology, and.
authors.forename: Vera
authors.initials: V
authors.lastname: Gelbricht
authors.affiliation: Center for Vascular Medicine and Department of Medicine III, Division of Angiology, and.
authors.forename: Christoph
authors.initials: C
authors.lastname: Thieme
authors.affiliation: Center for Vascular Medicine and Department of Medicine III, Division of Angiology, and.
authors.forename: Franziska
authors.initials: F
authors.lastname: Michalski
authors.affiliation: Center for Vascular Medicine and Department of Medicine III, Division of Angiology, and.
authors.forename: Christina
authors.initials: C
authors.lastname: Köhler
authors.affiliation: Center for Vascular Medicine and Department of Medicine III, Division of Angiology, and.
authors.forename: Sebastian
authors.initials: S
authors.lastname: Werth
authors.affiliation: ClinStat GmbH, Institute for Clinical Research and Statistics, Cologne, Germany.
authors.forename: Kurtulus
authors.initials: K
authors.lastname: Sahin
authors.affiliation: Center for Vascular Medicine and Department of Medicine III, Division of Angiology, and.
authors.forename: Luise
authors.initials: L
authors.lastname: Tittl
authors.affiliation: Center for Vascular Medicine and Department of Medicine III, Division of Angiology, and.
authors.forename: Ulrike
authors.initials: U
authors.lastname: Hänsel
authors.affiliation: Center for Vascular Medicine and Department of Medicine III, Division of Angiology, and.
authors.forename: Norbert
authors.initials: N
authors.lastname: Weiss
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000925:Anticoagulants / Q000009:adverse effects; D015331:Cohort Studies; D065427:Factor Xa Inhibitors / Q000009:adverse effects*; D005260:Female; D005858:Germany / Q000453:epidemiology; D006470:Hemorrhage / Q000139:chemically induced* / Q000401:mortality / Q000628:therapy*; D006801:Humans; D008297:Male; D008875:Middle Aged; D009025:Morpholines / Q000009:adverse effects*; D011446:Prospective Studies; D012042:Registries / Q000706:statistics & numerical data; D000069552:Rivaroxaban; D013876:Thiophenes / Q000009:adverse effects*; D016896:Treatment Outcome; D014812:Vitamin K / Q000037:antagonists & inhibitors
chemical_list: D000925:Anticoagulants; D065427:Factor Xa Inhibitors; D009025:Morpholines; D013876:Thiophenes; D014812:Vitamin K; D000069552:Rivaroxaban