Comparative safety and effectiveness of rivaroxaban versus VKAs in patients with venous thromboembolism: A Danish nationwide registry-based study

TY - JOUR

T1 - Comparative safety and effectiveness of rivaroxaban versus VKAs in patients with venous thromboembolism

T2 - A Danish nationwide registry-based study

AU - Sindet-Pedersen, Caroline

AU - Pallisgaard, Jannik Langtved

AU - Staerk, Laila

AU - Gerds, Thomas Alexander

AU - Fosbøl, Emil Loldrup

AU - Torp-Pedersen, Christian

AU - Gislason, Gunnar

AU - Olesen, Jonas Bjerring

PY - 2017/6

Y1 - 2017/6

N2 - 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.

AB - 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.

KW - Anticoagulation

KW - Non-vitamin k antagonist oral anticoagulants

KW - Rivaroxaban

KW - Venous thromboembolism

KW - Vitamin k antagonists

UR - http://www.scopus.com/inward/record.url?scp=85020298086&partnerID=8YFLogxK

U2 - 10.1160/TH16-10-0745

DO - 10.1160/TH16-10-0745

M3 - Journal article

AN - SCOPUS:85020298086

SN - 0340-6245

VL - 117

SP - 1182

EP - 1191

JO - Thrombosis et diathesis haemorrhagica

JF - Thrombosis et diathesis haemorrhagica

IS - 6

ER -