Effectiveness and safety of rivaroxaban vs warfarin in patients with pulmonary embolism and right ventricular dysfunction: a retrospective cohort study

Background: Limited data exist comparing the effectiveness and safety of rivaroxaban and warfarin in patients with right ventricular dysfunction (RVD), a common acute pulmonary embolism (PE) complication. Objectives: To assess the effectiveness and safety of rivaroxaban compared with warfarin among...

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Main Authors: François Laliberté, Behnood Bikdeli, Veronica Ashton, Guillaume Germain, Julien Boudreau, Manasvi Sundar, Sean D. MacKnight, Brahim Bookhart, Dereck Wentworth, Shawn Murphy, Yichuan G. Hsieh, Gregory Piazza
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Language:English
Published: Elsevier 2025-07-01
Series:Research and Practice in Thrombosis and Haemostasis
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Online Access:http://www.sciencedirect.com/science/article/pii/S2475037925002754
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author François Laliberté
Behnood Bikdeli
Veronica Ashton
Guillaume Germain
Julien Boudreau
Manasvi Sundar
Sean D. MacKnight
Brahim Bookhart
Dereck Wentworth
Shawn Murphy
Yichuan G. Hsieh
Gregory Piazza
author_facet François Laliberté
Behnood Bikdeli
Veronica Ashton
Guillaume Germain
Julien Boudreau
Manasvi Sundar
Sean D. MacKnight
Brahim Bookhart
Dereck Wentworth
Shawn Murphy
Yichuan G. Hsieh
Gregory Piazza
author_sort François Laliberté
collection DOAJ
description Background: Limited data exist comparing the effectiveness and safety of rivaroxaban and warfarin in patients with right ventricular dysfunction (RVD), a common acute pulmonary embolism (PE) complication. Objectives: To assess the effectiveness and safety of rivaroxaban compared with warfarin among patients with PE and RVD. Methods: Adult patients newly prescribed rivaroxaban or warfarin during PE-related hospitalization with evidence of RVD were identified from Mass General Brigham’s Research Patient Data Registry database (January 2013-May 2023). Outcomes included time-to-first recurrent venous thromboembolism (VTE) and time-to-first major bleeding event. The proportion of international normalized ratio (INR) measurements within therapeutic range (INR: 2-3) while on warfarin was described. Kaplan–Meier analysis described event rates at 6-month intervals up to 36 months, which were compared using hazard ratios, 95% CIs, and P values from Cox proportional hazards models. Results: Overall, 246 rivaroxaban and 315 warfarin users were included (mean age, 63 years; female: 53%). Median time of treatment was 270 and 235 days for rivaroxaban and warfarin users, respectively; 50.9% of INR measurements among warfarin users were within therapeutic range. Rivaroxaban was associated with significantly lower risk of VTE recurrence than warfarin at all-time points, including 41% lower risk at 36 months (20.4% vs 30.3%; hazard ratio [95% CI], 0.59 [0.38, 0.92]). There was no significant difference in risk of major bleeding between cohorts up to 36 months of treatment (8.2% vs 13.6%). Conclusion: Rivaroxaban was associated with lower risk of recurrent VTE compared with warfarin, without a significant difference in risk of major bleeding.
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spelling doaj-art-a711f77a3e9b413c99d3489f60e5459a2025-07-23T05:24:49ZengElsevierResearch and Practice in Thrombosis and Haemostasis2475-03792025-07-0195102951Effectiveness and safety of rivaroxaban vs warfarin in patients with pulmonary embolism and right ventricular dysfunction: a retrospective cohort studyFrançois Laliberté0Behnood Bikdeli1Veronica Ashton2Guillaume Germain3Julien Boudreau4Manasvi Sundar5Sean D. MacKnight6Brahim Bookhart7Dereck Wentworth8Shawn Murphy9Yichuan G. Hsieh10Gregory Piazza11Groupe d’analyse, société à responsabilité illimitée, Montréal, Québec, CanadaBrigham and Women’s Hospital, Boston, Massachusetts, USAJanssen Scientific Affairs, Limited Liability Company, a Johnson and Johnson company, Titusville, New Jersey, USAGroupe d’analyse, société à responsabilité illimitée, Montréal, Québec, Canada; Correspondence Guillaume Germain, Groupe d’analyse, société à responsabilité illimitée, 1190 avenue des Canadiens-de-Montréal, Suite 1500, Montréal, QC, H3B 0G7, Canada.Groupe d’analyse, société à responsabilité illimitée, Montréal, Québec, CanadaAnalysis Group, Inc, Los Angeles, California, USAGroupe d’analyse, société à responsabilité illimitée, Montréal, Québec, CanadaJanssen Scientific Affairs, Limited Liability Company, a Johnson and Johnson company, Titusville, New Jersey, USAJanssen Scientific Affairs, Limited Liability Company, a Johnson and Johnson company, Titusville, New Jersey, USAMass General Brigham, Somerville, Massachusetts, USAMass General Brigham, Somerville, Massachusetts, USABrigham and Women’s Hospital, Boston, Massachusetts, USABackground: Limited data exist comparing the effectiveness and safety of rivaroxaban and warfarin in patients with right ventricular dysfunction (RVD), a common acute pulmonary embolism (PE) complication. Objectives: To assess the effectiveness and safety of rivaroxaban compared with warfarin among patients with PE and RVD. Methods: Adult patients newly prescribed rivaroxaban or warfarin during PE-related hospitalization with evidence of RVD were identified from Mass General Brigham’s Research Patient Data Registry database (January 2013-May 2023). Outcomes included time-to-first recurrent venous thromboembolism (VTE) and time-to-first major bleeding event. The proportion of international normalized ratio (INR) measurements within therapeutic range (INR: 2-3) while on warfarin was described. Kaplan–Meier analysis described event rates at 6-month intervals up to 36 months, which were compared using hazard ratios, 95% CIs, and P values from Cox proportional hazards models. Results: Overall, 246 rivaroxaban and 315 warfarin users were included (mean age, 63 years; female: 53%). Median time of treatment was 270 and 235 days for rivaroxaban and warfarin users, respectively; 50.9% of INR measurements among warfarin users were within therapeutic range. Rivaroxaban was associated with significantly lower risk of VTE recurrence than warfarin at all-time points, including 41% lower risk at 36 months (20.4% vs 30.3%; hazard ratio [95% CI], 0.59 [0.38, 0.92]). There was no significant difference in risk of major bleeding between cohorts up to 36 months of treatment (8.2% vs 13.6%). Conclusion: Rivaroxaban was associated with lower risk of recurrent VTE compared with warfarin, without a significant difference in risk of major bleeding.http://www.sciencedirect.com/science/article/pii/S2475037925002754pulmonary embolismright ventricular dysfunctionrivaroxabanvenous thromboembolismwarfarin
spellingShingle François Laliberté
Behnood Bikdeli
Veronica Ashton
Guillaume Germain
Julien Boudreau
Manasvi Sundar
Sean D. MacKnight
Brahim Bookhart
Dereck Wentworth
Shawn Murphy
Yichuan G. Hsieh
Gregory Piazza
Effectiveness and safety of rivaroxaban vs warfarin in patients with pulmonary embolism and right ventricular dysfunction: a retrospective cohort study
Research and Practice in Thrombosis and Haemostasis
pulmonary embolism
right ventricular dysfunction
rivaroxaban
venous thromboembolism
warfarin
title Effectiveness and safety of rivaroxaban vs warfarin in patients with pulmonary embolism and right ventricular dysfunction: a retrospective cohort study
title_full Effectiveness and safety of rivaroxaban vs warfarin in patients with pulmonary embolism and right ventricular dysfunction: a retrospective cohort study
title_fullStr Effectiveness and safety of rivaroxaban vs warfarin in patients with pulmonary embolism and right ventricular dysfunction: a retrospective cohort study
title_full_unstemmed Effectiveness and safety of rivaroxaban vs warfarin in patients with pulmonary embolism and right ventricular dysfunction: a retrospective cohort study
title_short Effectiveness and safety of rivaroxaban vs warfarin in patients with pulmonary embolism and right ventricular dysfunction: a retrospective cohort study
title_sort effectiveness and safety of rivaroxaban vs warfarin in patients with pulmonary embolism and right ventricular dysfunction a retrospective cohort study
topic pulmonary embolism
right ventricular dysfunction
rivaroxaban
venous thromboembolism
warfarin
url http://www.sciencedirect.com/science/article/pii/S2475037925002754
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