CC BY-NC-ND 4.0 · Thromb Haemost 2022; 122(06): 926-938
DOI: 10.1055/s-0041-1740254
Coagulation and Fibrinolysis

Effectiveness and Safety of Apixaban versus Warfarin in Venous Thromboembolism Patients with Chronic Kidney Disease

Alexander T. Cohen
1   Department of Hematological Medicine, Guy's & St. Thomas' NHS Foundation Trust, King's College London, London, United Kingdom
,
Janvi Sah
2   SIMR, LLC, Ann Arbor, Michigan, United States
,
Amol D. Dhamane
3   Bristol Myers Squibb Company, Lawrenceville, New Jersey, United States
,
Theodore Lee
4   Pfizer Inc., New York, New York, United States
,
Lisa Rosenblatt
3   Bristol Myers Squibb Company, Lawrenceville, New Jersey, United States
,
Patrick Hlavacek
4   Pfizer Inc., New York, New York, United States
,
Birol Emir
4   Pfizer Inc., New York, New York, United States
,
Rachel Delinger
2   SIMR, LLC, Ann Arbor, Michigan, United States
,
Huseyin Yuce
5   Department of Mathematics, New York City College of Technology, City University of New York, New York, New York, United States
,
Xuemei Luo
6   Pfizer Inc., Groton, Connecticut, United States
› Author Affiliations
Funding This research was funded by Pfizer and Bristol Myers Squibb.

Abstract

There has been limited evidence reported about the outcomes of oral anticoagulants among patients with venous thromboembolism (VTE) and chronic kidney disease (CKD), especially those with stage V/end-stage renal disease (ESRD). This retrospective cohort analysis of five U.S. claims databases evaluated the risk of recurrent VTE, major bleeding (MB), and clinically relevant nonmajor bleeding (CRNMB) for apixaban versus warfarin among VTE patients diagnosed with CKD, including ESRD. Inverse probability treatment weighting (IPTW) was used to balance patient characteristics between treatment cohorts. Hazard ratios (HRs) were calculated for recurrent VTE, MB, and CRNMB among patients with CKD who experienced an index VTE. An interaction analysis was conducted to evaluate treatment effects across different stages of CKD. A total of 29,790 VTE patients with CKD were selected for analyses, of whom 10,669 (35.8%) initiated apixaban and 19,121 (64.2%) initiated warfarin. Among IPTW-balanced patient cohorts, the apixaban group had significantly lower risk of recurrent VTE (HR: 0.78; 95% confidence interval [CI]: 0.66–0.92), MB (HR: 0.76; 95% CI: 0.65–0.88), and CRNMB (HR: 0.86; 95% CI: 0.80–0.93) than the warfarin group. When stratified by CKD stage (stage I/II: 8.2%; stage III: 49.4%; stage IV: 12.8%; stage V/ESRD: 12.0%; stage unspecified: 17.6%), no significant interaction was observed for effects of apixaban versus warfarin on recurrent VTE or MB. In summary, apixaban was associated with a significantly lower risk of recurrent VTE and MB than warfarin among VTE patients with CKD. CKD stages did not have significant impact on treatment effects for recurrent VTE and MB.

Author Contributions

All authors were involved in conceptualization, methodology, and writing and review of the manuscript. The statistical analysis was performed by J. Sah and R. Delinger, employees of STATinMED Research, a paid consultant to Pfizer and Bristol Myers Squibb Company.




Publication History

Received: 12 April 2021

Accepted: 10 October 2021

Article published online:
28 December 2021

© 2021. The Author(s). This is an open access article published by Thieme under the terms of the Creative Commons Attribution-NonDerivative-NonCommercial License, permitting copying and reproduction so long as the original work is given appropriate credit. Contents may not be used for commercial purposes, or adapted, remixed, transformed or built upon. (https://creativecommons.org/licenses/by-nc-nd/4.0/)

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