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

Caroline Sindet-Pedersen, Laila Staerk, Jannik Langtved Pallisgaard, Thomas Alexander Gerds, Jeffrey S. Berger, Christian Torp-Pedersen, Gunnar H. Gislason, Jonas Bjerring Olesen

Research output: Contribution to journalJournal articleResearchpeer-review

Abstract

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.

Original languageEnglish
JournalEuropean Heart Journal - Cardiovascular Pharmacotherapy
Volume4
Issue number4
Pages (from-to)220-227
ISSN2055-6837
DOIs
Publication statusPublished - 1. Oct 2018

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Confidence Intervals
Safety
Rivaroxaban
apixaban
Proportional Hazards Models
Registries

Keywords

  • Anticoagulation
  • Apixaban
  • Bleeding
  • Non-Vitamin K antagonist oral anticoagulants
  • Rivaroxaban
  • Venous thromboembolism
  • Recurrence
  • Humans
  • Middle Aged
  • Male
  • Rivaroxaban/adverse effects
  • Time Factors
  • Aged, 80 and over
  • Fibrinolytic Agents/adverse effects
  • Female
  • Registries
  • Retrospective Studies
  • Pyridones/adverse effects
  • Risk Factors
  • Treatment Outcome
  • Hospitalization
  • Pyrazoles/adverse effects
  • Venous Thromboembolism/diagnosis
  • Hemorrhage/chemically induced
  • Factor Xa Inhibitors/adverse effects
  • Denmark/epidemiology
  • Aged

Cite this

Sindet-Pedersen, C., Staerk, L., Pallisgaard, J. L., Gerds, T. A., Berger, J. S., Torp-Pedersen, C., ... Olesen, J. B. (2018). Safety and effectiveness of rivaroxaban and apixaban in patients with venous thromboembolism: a nationwide study. European Heart Journal - Cardiovascular Pharmacotherapy, 4(4), 220-227. https://doi.org/10.1093/ehjcvp/pvy021
Sindet-Pedersen, Caroline ; Staerk, Laila ; Pallisgaard, Jannik Langtved ; Gerds, Thomas Alexander ; Berger, Jeffrey S. ; Torp-Pedersen, Christian ; Gislason, Gunnar H. ; Olesen, Jonas Bjerring. / Safety and effectiveness of rivaroxaban and apixaban in patients with venous thromboembolism : a nationwide study. In: European Heart Journal - Cardiovascular Pharmacotherapy. 2018 ; Vol. 4, No. 4. pp. 220-227.
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title = "Safety and effectiveness of rivaroxaban and apixaban in patients with venous thromboembolism: a nationwide study",
abstract = "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.",
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author = "Caroline Sindet-Pedersen and Laila Staerk and Pallisgaard, {Jannik Langtved} and Gerds, {Thomas Alexander} and Berger, {Jeffrey S.} and Christian Torp-Pedersen and Gislason, {Gunnar H.} and Olesen, {Jonas Bjerring}",
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Safety and effectiveness of rivaroxaban and apixaban in patients with venous thromboembolism : a nationwide study. / Sindet-Pedersen, Caroline; Staerk, Laila; Pallisgaard, Jannik Langtved; Gerds, Thomas Alexander; Berger, Jeffrey S.; Torp-Pedersen, Christian; Gislason, Gunnar H.; Olesen, Jonas Bjerring.

In: European Heart Journal - Cardiovascular Pharmacotherapy, Vol. 4, No. 4, 01.10.2018, p. 220-227.

Research output: Contribution to journalJournal articleResearchpeer-review

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 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 - Anticoagulation

KW - Apixaban

KW - Bleeding

KW - Non-Vitamin K antagonist oral anticoagulants

KW - Rivaroxaban

KW - Venous thromboembolism

KW - Recurrence

KW - Humans

KW - Middle Aged

KW - Male

KW - Rivaroxaban/adverse effects

KW - Time Factors

KW - Aged, 80 and over

KW - Fibrinolytic Agents/adverse effects

KW - Female

KW - Registries

KW - Retrospective Studies

KW - Pyridones/adverse effects

KW - Risk Factors

KW - Treatment Outcome

KW - Hospitalization

KW - Pyrazoles/adverse effects

KW - Venous Thromboembolism/diagnosis

KW - Hemorrhage/chemically induced

KW - Factor Xa Inhibitors/adverse effects

KW - Denmark/epidemiology

KW - Aged

U2 - 10.1093/ehjcvp/pvy021

DO - 10.1093/ehjcvp/pvy021

M3 - Journal article

C2 - 29945162

AN - SCOPUS:85058442805

VL - 4

SP - 220

EP - 227

JO - European Heart Journal - Cardiovascular Pharmacotherapy

JF - European Heart Journal - Cardiovascular Pharmacotherapy

SN - 2055-6837

IS - 4

ER -