Safety and effectiveness of rivaroxaban and apixaban in patients with venous thromboembolism: a nationwide study

TY - JOUR

T1 - Safety and effectiveness of rivaroxaban and apixaban in patients with venous thromboembolism

T2 - a nationwide study

AU - Sindet-Pedersen, Caroline

AU - Staerk, Laila

AU - Pallisgaard, Jannik Langtved

AU - Gerds, Thomas Alexander

AU - Berger, Jeffrey S

AU - Torp-Pedersen, Christian

AU - Gislason, Gunnar H

AU - Olesen, Jonas Bjerring

PY - 2018/10/1

Y1 - 2018/10/1

N2 - Aims To investigate the risk of all-cause mortality, recurrent venous thromboembolism (VTE), and hospitalized bleeding in patients with VTE treated with either rivaroxaban or apixaban. Methods Using Danish nationwide registries, patients with VTE treated with rivaroxaban or apixaban in the period from 1 and results January 2015 to 30 June 2017 were identified. Standardized absolute risks were estimated based on outcome-specific Cox regression models, adjusted for potential confounders. A total of 8187 patients were included in the study, of which 1504 (18%) were treated with apixaban [50% males, median age 70 years; interquartile range (IQR) 56–80] and 6683 (82%) were treated with rivaroxaban (55% males, median age 67 years; IQR 53–76). The 180 days risk of all-cause mortality was 5.08% [95% confidence interval (95% CI) 4.08% to 6.08%)] in the apixaban group and 4.60% (95% CI 4.13% to 5.18%) in the rivaroxaban group [absolute risk difference: -0.48% (95% CI -1.49% to 0.72%)]. The 180 days risk of recurrent VTE was 2.16% (95% CI 1.49% to 2.88%) in the apixaban group and 2.22% (95% CI 1.89% to 2.52%) in the rivaroxaban group [absolute risk difference of 0.06% (95% CI -0.72% to 0.79%)]. The 180 days risk of hospitalized bleeding was 1.73% (95% CI 1.22% to 2.35%) for patients in the apixaban group and 1.89% (95% CI 1.56% to 2.20%) in the rivaroxaban group [absolute risk difference: 0.16% (95% CI -0.59% to 0.81%)]. Conclusion In a nationwide cohort of 8187 patients with VTE treated with rivaroxaban or apixaban, there were no significant differences in the risks of all-cause mortality, recurrent VTE, or hospitalized bleeding.

AB - Aims To investigate the risk of all-cause mortality, recurrent venous thromboembolism (VTE), and hospitalized bleeding in patients with VTE treated with either rivaroxaban or apixaban. Methods Using Danish nationwide registries, patients with VTE treated with rivaroxaban or apixaban in the period from 1 and results January 2015 to 30 June 2017 were identified. Standardized absolute risks were estimated based on outcome-specific Cox regression models, adjusted for potential confounders. A total of 8187 patients were included in the study, of which 1504 (18%) were treated with apixaban [50% males, median age 70 years; interquartile range (IQR) 56–80] and 6683 (82%) were treated with rivaroxaban (55% males, median age 67 years; IQR 53–76). The 180 days risk of all-cause mortality was 5.08% [95% confidence interval (95% CI) 4.08% to 6.08%)] in the apixaban group and 4.60% (95% CI 4.13% to 5.18%) in the rivaroxaban group [absolute risk difference: -0.48% (95% CI -1.49% to 0.72%)]. The 180 days risk of recurrent VTE was 2.16% (95% CI 1.49% to 2.88%) in the apixaban group and 2.22% (95% CI 1.89% to 2.52%) in the rivaroxaban group [absolute risk difference of 0.06% (95% CI -0.72% to 0.79%)]. The 180 days risk of hospitalized bleeding was 1.73% (95% CI 1.22% to 2.35%) for patients in the apixaban group and 1.89% (95% CI 1.56% to 2.20%) in the rivaroxaban group [absolute risk difference: 0.16% (95% CI -0.59% to 0.81%)]. Conclusion In a nationwide cohort of 8187 patients with VTE treated with rivaroxaban or apixaban, there were no significant differences in the risks of all-cause mortality, recurrent VTE, or hospitalized bleeding.

KW - Aged

KW - Aged, 80 and over

KW - Denmark/epidemiology

KW - Factor Xa Inhibitors/adverse effects

KW - Female

KW - Fibrinolytic Agents/adverse effects

KW - Hemorrhage/chemically induced

KW - Hospitalization

KW - Humans

KW - Male

KW - Middle Aged

KW - Pyrazoles/adverse effects

KW - Pyridones/adverse effects

KW - Recurrence

KW - Registries

KW - Retrospective Studies

KW - Risk Factors

KW - Rivaroxaban/adverse effects

KW - Time Factors

KW - Treatment Outcome

KW - Venous Thromboembolism/diagnosis

U2 - 10.1093/ehjcvp/pvy021

DO - 10.1093/ehjcvp/pvy021

M3 - Journal article

C2 - 29945162

SN - 2055-6837

VL - 4

SP - 220

EP - 227

JO - European Heart Journal - Cardiovascular Pharmacotherapy

JF - European Heart Journal - Cardiovascular Pharmacotherapy

IS - 4

ER -