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

Y1 - 2018

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 and results: Using Danish nationwide registries, patients with VTE treated with rivaroxaban or apixaban in the period from 1 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 and results: Using Danish nationwide registries, patients with VTE treated with rivaroxaban or apixaban in the period from 1 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

VL - 4

SP - 220

EP - 227

JO - European Heart Journal - Cardiovascular Pharmacotherapy

JF - European Heart Journal - Cardiovascular Pharmacotherapy

SN - 2055-6837

IS - 4

ER -