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Published in: Thrombosis Journal 1/2020

01-12-2020 | Oral Anticoagulant | Research

Rivaroxaban versus warfarin for treatment and prevention of recurrence of venous thromboembolism in African American patients: a retrospective cohort analysis

Authors: Olivia S. Costa, Stanley Thompson, Veronica Ashton, Michael Palladino, Thomas J. Bunz, Craig I. Coleman

Published in: Thrombosis Journal | Issue 1/2020

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Abstract

Background

African Americans are under-represented in trials evaluating oral anticoagulants for the treatment of acute venous thromboembolism (VTE). The aim of this study was to evaluate the effectiveness and safety of rivaroxaban versus warfarin for the treatment of VTE in African Americans.

Methods

We utilized Optum® De-Identified Electronic Health Record data from 11/1/2012–9/30/2018. We included African Americans experiencing an acute VTE during a hospital or emergency department visit, who received rivaroxaban or warfarin as their first oral anticoagulant within 7-days of the acute VTE event and had ≥1 provider visit in the prior 12-months. Differences in baseline characteristics between cohorts were adjusted using inverse probability-of-treatment weighting based on propensity scores (standard differences < 0.10 were achieved for all covariates). Our primary endpoint was the composite of recurrent VTE or major bleeding at 6-months. Three- and 12-month timepoints were also assessed. Secondary endpoints included recurrent VTE and major bleeding as individual endpoints. Cohort risk was compared using Cox regression and reported as hazard ratios (HRs) with 95% confidence intervals (CIs).

Results

We identified 2097 rivaroxaban and 2842 warfarin users with incident VTE. At 6-months, no significant differences in the composite endpoint (HR = 0.96, 95%CI = 0.75–1.24), recurrent VTE (HR = 1.02, 95%CI = 0.76–1.36) or major bleeding alone (HR = 0.93, 95%CI = 0.59–1.47) were observed between cohorts. Analysis at 3- and 12-months provided consistent findings for these endpoints.

Conclusions

In African Americans experiencing an acute VTE, no significant difference in the incidence of recurrent VTE or major bleeding was observed between patients receiving rivaroxaban or warfarin.
Literature
1.
go back to reference White RH, Zhou H, Romano PS. Incidence of idiopathic deep venous thrombosis and secondary thromboembolism among ethnic groups in California. Ann Intern Med. 1998;128:737–40.CrossRef White RH, Zhou H, Romano PS. Incidence of idiopathic deep venous thrombosis and secondary thromboembolism among ethnic groups in California. Ann Intern Med. 1998;128:737–40.CrossRef
2.
go back to reference White RH, Zhou H, Murin S, Harvey D. Effect of ethnicity and gender on the incidence of venous thromboembolism in a diverse population in California in 1996. Thromb Haemost. 2005;93:298–305.CrossRef White RH, Zhou H, Murin S, Harvey D. Effect of ethnicity and gender on the incidence of venous thromboembolism in a diverse population in California in 1996. Thromb Haemost. 2005;93:298–305.CrossRef
3.
go back to reference Schneider D, Lilienfeld DE, Im W. The epidemiology of pulmonary embolism: racial contrasts in incidence and in-hospital case fatality. J Natl Med Assoc. 2006;98:1967–72.PubMedPubMedCentral Schneider D, Lilienfeld DE, Im W. The epidemiology of pulmonary embolism: racial contrasts in incidence and in-hospital case fatality. J Natl Med Assoc. 2006;98:1967–72.PubMedPubMedCentral
4.
go back to reference Dowling NF, Austin H, Dilley A, Whitsett C, Evatt BL, Hooper WC. The epidemiology of venous thromboembolism in Caucasians and African-Americans: the GATE study. J Thromb Haemost. 2003;1:80–7.CrossRef Dowling NF, Austin H, Dilley A, Whitsett C, Evatt BL, Hooper WC. The epidemiology of venous thromboembolism in Caucasians and African-Americans: the GATE study. J Thromb Haemost. 2003;1:80–7.CrossRef
5.
go back to reference Jackson LR 2nd, Peterson ED, Okeagu E, Thomas K. Review of race/ethnicity in non vitamin K antagonist oral anticoagulants clinical trials. J Thromb Thrombolysis. 2015;39:222–7.CrossRef Jackson LR 2nd, Peterson ED, Okeagu E, Thomas K. Review of race/ethnicity in non vitamin K antagonist oral anticoagulants clinical trials. J Thromb Thrombolysis. 2015;39:222–7.CrossRef
6.
go back to reference Di Nisio M, Ageno W, Rutjes AW, Pap AF, Büller HR. Risk of major bleeding in patients with venous thromboembolism treated with rivaroxaban or with heparin and vitamin K antagonists. Thromb Haemost. 2016;115:424–32.CrossRef Di Nisio M, Ageno W, Rutjes AW, Pap AF, Büller HR. Risk of major bleeding in patients with venous thromboembolism treated with rivaroxaban or with heparin and vitamin K antagonists. Thromb Haemost. 2016;115:424–32.CrossRef
7.
go back to reference Agnelli G, Buller HR, Cohen A, et al. Oral apixaban for the treatment of acute venous thromboembolism. N Engl J Med. 2013;369:799–808.CrossRef Agnelli G, Buller HR, Cohen A, et al. Oral apixaban for the treatment of acute venous thromboembolism. N Engl J Med. 2013;369:799–808.CrossRef
8.
go back to reference Buller HR, Decousus H, Grosso MA, et al. Edoxaban versus warfarin for the treatment of symptomatic venous thromboembolism. N Engl J Med. 2014;369:1406–15. Buller HR, Decousus H, Grosso MA, et al. Edoxaban versus warfarin for the treatment of symptomatic venous thromboembolism. N Engl J Med. 2014;369:1406–15.
9.
go back to reference Prins MH, Lensing AW, Bauersachs R, et al. Oral rivaroxaban versus standard therapy for the treatment of symptomatic venous thromboembolism: a pooled analysis of the EINSTEIN-DVT and PE randomized studies. Thromb J. 2013;11:21.CrossRef Prins MH, Lensing AW, Bauersachs R, et al. Oral rivaroxaban versus standard therapy for the treatment of symptomatic venous thromboembolism: a pooled analysis of the EINSTEIN-DVT and PE randomized studies. Thromb J. 2013;11:21.CrossRef
10.
go back to reference Schulman S, Kearson C, Kakkar AK, et al. Dabigatran versus warfarin in the treatment of acute venous thromboembolism. N Engl J Med. 2009;361:2342–52.CrossRef Schulman S, Kearson C, Kakkar AK, et al. Dabigatran versus warfarin in the treatment of acute venous thromboembolism. N Engl J Med. 2009;361:2342–52.CrossRef
12.
go back to reference White RH, Garcia M, Sadeghi B, et al. Evaluation of the predictive value of ICD-9-CM coded administrative data for venous thromboembolism in the United States. Thromb Res. 2010;126:61–7.CrossRef White RH, Garcia M, Sadeghi B, et al. Evaluation of the predictive value of ICD-9-CM coded administrative data for venous thromboembolism in the United States. Thromb Res. 2010;126:61–7.CrossRef
13.
go back to reference Cunningham A, Stein CM, Chung CP, Daugherty JR, Smalley WE, Ray WA. An automated database case definition for serious bleeding related to oral anticoagulant use. Pharmacoepidemiol Drug Saf. 2011;20:560–6.CrossRef Cunningham A, Stein CM, Chung CP, Daugherty JR, Smalley WE, Ray WA. An automated database case definition for serious bleeding related to oral anticoagulant use. Pharmacoepidemiol Drug Saf. 2011;20:560–6.CrossRef
14.
go back to reference Austin PC. An introduction to propensity score methods for reducing the effects of confounding in observational studies. Multivariate Behav Res. 2011;46:399–424.CrossRef Austin PC. An introduction to propensity score methods for reducing the effects of confounding in observational studies. Multivariate Behav Res. 2011;46:399–424.CrossRef
15.
go back to reference Benchimol EI, Smeeth L, Guttmann A, Harron K, Moher D, Petersen I, Sørensen HT, von Elm E, Langan SM. RECORD Working Committee. The REporting of studies Conducted using Observational Routinely-collected health Data (RECORD) statement. PLoS Med. 2015;12:e1001885.CrossRef Benchimol EI, Smeeth L, Guttmann A, Harron K, Moher D, Petersen I, Sørensen HT, von Elm E, Langan SM. RECORD Working Committee. The REporting of studies Conducted using Observational Routinely-collected health Data (RECORD) statement. PLoS Med. 2015;12:e1001885.CrossRef
16.
go back to reference Ageno W, Mantovani LG, Haas S. Safety and effectiveness of oral rivaroxaban versus standard anticoagulation for the treatment of symptomatic deep-vein thrombosis (XALIA): an international prospective, non-interventional study. Lancet Haematol. 2016;3:e12–21.CrossRef Ageno W, Mantovani LG, Haas S. Safety and effectiveness of oral rivaroxaban versus standard anticoagulation for the treatment of symptomatic deep-vein thrombosis (XALIA): an international prospective, non-interventional study. Lancet Haematol. 2016;3:e12–21.CrossRef
17.
go back to reference Gandhi SK, Salmon W, Kong SX, Zhao SZ. Administrative databases and outcomes assessment: an overview of issues and potential utility. J Manag Care Spec Pharm. 1999;5:215–22. Gandhi SK, Salmon W, Kong SX, Zhao SZ. Administrative databases and outcomes assessment: an overview of issues and potential utility. J Manag Care Spec Pharm. 1999;5:215–22.
18.
go back to reference Coleman CI, Turpie AG, Bunz TJ, Beyer-Westendorf J. Effectiveness and safety of rivaroxaban versus warfarin in patients with provoked venous thromboembolism. J Thromb Thrombolysis. 2018;46:339–45. Coleman CI, Turpie AG, Bunz TJ, Beyer-Westendorf J. Effectiveness and safety of rivaroxaban versus warfarin in patients with provoked venous thromboembolism. J Thromb Thrombolysis. 2018;46:339–45.
20.
go back to reference Limone BL, Hernandez AV, Michalak D, Bookhart BK, Coleman CI. Timing of recurrent venous thromboembolism early after the index event: a meta-analysis of randomized controlled trials. Thromb Res. 2013;132:420–6.CrossRef Limone BL, Hernandez AV, Michalak D, Bookhart BK, Coleman CI. Timing of recurrent venous thromboembolism early after the index event: a meta-analysis of randomized controlled trials. Thromb Res. 2013;132:420–6.CrossRef
21.
go back to reference Yong C, Xu X, Than C, Ullal A, Schmitt S, Azarbal F, Heidenreich P, Turakhia M. Racial disparities in warfarin time in INR therapeutic range in patients with atrial fibrillation: findings from the TREAT-AF study. Circulation. 2013;128:A14134.CrossRef Yong C, Xu X, Than C, Ullal A, Schmitt S, Azarbal F, Heidenreich P, Turakhia M. Racial disparities in warfarin time in INR therapeutic range in patients with atrial fibrillation: findings from the TREAT-AF study. Circulation. 2013;128:A14134.CrossRef
Metadata
Title
Rivaroxaban versus warfarin for treatment and prevention of recurrence of venous thromboembolism in African American patients: a retrospective cohort analysis
Authors
Olivia S. Costa
Stanley Thompson
Veronica Ashton
Michael Palladino
Thomas J. Bunz
Craig I. Coleman
Publication date
01-12-2020
Publisher
BioMed Central
Published in
Thrombosis Journal / Issue 1/2020
Electronic ISSN: 1477-9560
DOI
https://doi.org/10.1186/s12959-020-00219-w

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