New Publication: Risk for Recurrent Venous Thromboembolism and Bleeding With Apixaban Compared With Rivaroxaban: An Analysis of Real-World Data. Dawwas, et. al

Risk for Recurrent Venous Thromboembolism and Bleeding With Apixaban Compared With Rivaroxaban: An Analysis of Real-World Data

Ghadeer K. Dawwas, MSc, MBA, PhD; Charles E. Leonard, PharmD, MSCE; James D. Lewis, MD, MSCE; Adam Cuker, MD, MS

Abstract:

Background: Apixaban and rivaroxaban are replacing vitamin K antagonists for the treatment of venous thromboembolism (VTE) in adults; however, head-to-head comparisons remain limited.

Objective: To assess the effectiveness and safety of apixaban compared with rivaroxaban in patients with VTE.

Design: Retrospective new-user cohort study.

Setting: U.S.-based commercial health care insurance database from 1 January 2015 to 30 June 2020.

Participants: Adults with VTE who were newly prescribed apixaban or rivaroxaban.

Measurements: The primary effectiveness outcome was recurrent VTE, a composite of deep venous thrombosis and pulmonary embolism. The primary safety outcome was a composite of gastrointestinal and intracranial bleeding.

Results: Of 49 900 eligible patients with VTE, 18 618 were new users of apixaban and 18 618 were new users of rivaroxaban. Median follow-up was 102 days (25th, 75th percentiles: 30, 128 days) among apixaban and 105 days (25th, 75th percentiles: 30, 140 days) among rivaroxaban users. After propensity score matching, apixaban (vs. rivaroxaban) was associated with a lower rate for recurrent VTE (hazard ratio, 0.77 [95% CI, 0.69 to 0.87]) and bleeding (hazard ratio, 0.60 [CI, 0.53 to 0.69]). The absolute reduction in the probability of recurrent VTE with apixaban versus rivaroxaban was 0.006 (CI, 0.005 to 0.011) within 2 months and 0.011 (CI, 0.011 to 0.013) within 6 months of initiation. The absolute reduction in the probability of gastrointestinal and intracranial bleeding with apixaban versus rivaroxaban was 0.011 (CI, 0.010 to 0.011) within 2 months and 0.015 (CI, 0.013 to 0.015) within 6 months of initiation.

Limitation: Short follow-up.

Conclusion: In this population-based cohort study, patients with VTE who were new users of apixaban had lower rates for recurrent VTE and bleeding than new users of rivaroxaban.

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CREST members develop real-world evidence about the health effects of medications and other medical products, and prepare the next generation of pharmacoepidemiology leaders. CREST is an academic partner to the Food and Drug Administration (FDA)-funded Sentinel Initiative. CREST members are also editors of the journal Pharmacoepidemiology and Drug Safety, and the books Pharmacoepidemiology, 6th edition and Textbook of Pharmacoepidemiology, 3rd edition.   

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