title: Comparative safety and effectiveness of rivaroxaban versus VKAs in patients with venous thromboembolism. A Danish nationwide registry-based study.
abstract: The approval of rivaroxaban has changed the landscape of treatment of venous thromboembolism (VTE). Little is known about the effect of rivaroxaban compared with vitamin K antagonists (VKA), when used in the everyday clinical practice. The aim of this study was to investigate the safety and effectiveness of rivaroxaban compared with VKAs among patients with VTE, using the Danish nationwide registries. All patients diagnosed with VTE and treated with either rivaroxaban or VKAs between 2013 and 2015 were included. A total of 12,318 patients were diagnosed with VTE and treated with VKAs [n=6,907] or rivaroxaban [n=5,411.]. Combined Cox regression analyses showed that the standardised absolute six-month risk of recurrent VTE was 3.03 % [95 % CI: 2.57 % to 3.48 %] in the rivaroxaban group and 3.13 % [95 % CI: 2.70 % to 3.56 %] in the VKA group (absolute risk difference of -0.11 % [95 % CI: -0.76 % to 0.54 %]). The standardised absolute six-months risk of bleeding was 2.28 % [95 % CI: 1.87 % to 2.67 %] for patients in the rivaroxaban group and 2.10 % [95 % CI: 1.78 % to 2.43 %] in the VKA group (absolute risk difference of 0.18 % [95 % CI: -0.34 % to 0.67]). In conclusion, rivaroxaban was associated with similar risk of recurrent VTE and bleeding compared with VKA.
authors.affiliation: Caroline Sindet-Pedersen, M.Sc., Department of Cardiology, Copenhagen University Hospital Herlev and Gentofte, Post 635, Kildegaardsvej 28, 2900 Hellerup, Denmark, Tel.: +45 30220429, Fax: +45 70201282, E-mail: carolinesindet@gmail.com.
authors.forename: Caroline
authors.initials: C
authors.lastname: Sindet-Pedersen
authors.forename: Jannik
authors.initials: J
authors.lastname: Langtved Pallisgaard
authors.forename: Laila
authors.initials: L
authors.lastname: Staerk
authors.forename: Thomas Alexander
authors.initials: TA
authors.lastname: Gerds
authors.forename: Emil Loldrup
authors.initials: EL
authors.lastname: Fosbøl
authors.forename: Christian
authors.initials: C
authors.lastname: Torp-Pedersen
authors.forename: Gunnar
authors.initials: G
authors.lastname: Gislason
authors.forename: Jonas Bjerring
authors.initials: JB
authors.lastname: Olesen
mesh_terms: D000284:Administration, Oral; D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000925:Anticoagulants / Q000627:therapeutic use*; D015331:Cohort Studies; D015897:Comorbidity; D003718:Denmark / Q000453:epidemiology; D005260:Female; D005500:Follow-Up Studies; D006470:Hemorrhage / Q000209:etiology / Q000517:prevention & control*; D006801:Humans; D008297:Male; D008875:Middle Aged; D012008:Recurrence; D012042:Registries; D012306:Risk; D000069552:Rivaroxaban / Q000627:therapeutic use*; D054556:Venous Thromboembolism / Q000150:complications / Q000188:drug therapy* / Q000453:epidemiology; D014812:Vitamin K / Q000037:antagonists & inhibitors*; D055815:Young Adult
chemical_list: D000925:Anticoagulants; D014812:Vitamin K; D000069552:Rivaroxaban
keywords: Venous thromboembolism; anticoagulation; non-vitamin K antagonist oral anticoagulants; rivaroxaban; vitamin K antagonists