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Effectiveness and safety of apixaban versus rivaroxaban for prevention of recurrent venous thromboembolism and adverse bleeding events in patients with venous thromboembolism: a retrospective population-based cohort analysis.
Lancet Haematol. 2019 Jan; 6(1):e20-e28.LH

Abstract

BACKGROUND

Apixaban and rivaroxaban, both direct-acting oral anticoagulants, are being increasingly used in routine clinical practice because of their fixed dosing and favourable pharmacological profiles. Differences in the risk of recurrent venous thromboembolism and major bleeding events between the two drugs are currently unknown. We aimed to compare the effectiveness and safety of apixaban and rivaroxaban in prevention of recurrent venous thromboembolism and major bleeding events in patients with venous thromboembolism.

METHODS

We did a retrospective cohort analysis of data from the Truven Health MarketScan commercial and Medicare Supplement claims databases in the USA. We analysed data for adult patients with newly diagnosed venous thromboembolism (deep vein thrombosis or pulmonary embolism) who were new users of apixaban or rivaroxaban between Jan 1, 2014, and Dec 31, 2016. Patients who did not initiate the study drugs within 30 days of their diagnosis, those without 12 months of continuous enrolment in medical and pharmacy benefits, and those who used other anticoagulants during the baseline period were excluded. The primary effectiveness outcome was the incidence of recurrent venous thromboembolism and the primary safety outcome was the incidence of major bleeding events. Cox-proportional hazard models after propensity score matching were used to calculate the hazard ratio (HR) and 95% CI.

FINDINGS

After propensity score matching, 15 254 patients were included in the cohort (3091 apixaban users and 12 163 rivaroxaban users). The crude incidence of recurrent venous thromboembolism was three per 100 person-years in the apixaban group and seven per 100 person-years in the rivaroxaban group. The incidence of major bleeding was three per 100 person-years in the apixaban group and six per 100 person-years in the rivaroxaban group. In multivariable Cox regression models, the use of apixaban compared with rivaroxaban was associated with decreased risk of recurrent venous thromboembolism (HR 0·37 [95% CI 0·24-0·55]; p<0·0001) and major bleeding events (0·54 [0·37-0·82]; p=0·0031).

INTERPRETATION

Based on our findings, apixaban seems to be more effective than rivaroxaban in preventing the development of recurrent venous thromboembolism and major bleeding events. Our data might give some assurance to clinicians that apixaban can be an effective and safe therapeutic option for treatment of patients with venous thromboembolism.

FUNDING

None.

Authors+Show Affiliations

Department of Pharmaceutical Outcomes and Policy, College of Pharmacy, University of Florida, Gainesville, FL, USA.Department of Pharmaceutical Outcomes and Policy, College of Pharmacy, University of Florida, Gainesville, FL, USA.Department of Pharmacotherapy and Translational Research, College of Pharmacy, University of Florida, Gainesville, FL, USA.Department of Pharmaceutical Outcomes and Policy, College of Pharmacy, University of Florida, Gainesville, FL, USA. Electronic address: hpark@cop.ufl.edu.

Pub Type(s)

Journal Article

Language

eng

PubMed ID

30558988

Citation

Dawwas, Ghadeer K., et al. "Effectiveness and Safety of Apixaban Versus Rivaroxaban for Prevention of Recurrent Venous Thromboembolism and Adverse Bleeding Events in Patients With Venous Thromboembolism: a Retrospective Population-based Cohort Analysis." The Lancet. Haematology, vol. 6, no. 1, 2019, pp. e20-e28.
Dawwas GK, Brown J, Dietrich E, et al. Effectiveness and safety of apixaban versus rivaroxaban for prevention of recurrent venous thromboembolism and adverse bleeding events in patients with venous thromboembolism: a retrospective population-based cohort analysis. Lancet Haematol. 2019;6(1):e20-e28.
Dawwas, G. K., Brown, J., Dietrich, E., & Park, H. (2019). Effectiveness and safety of apixaban versus rivaroxaban for prevention of recurrent venous thromboembolism and adverse bleeding events in patients with venous thromboembolism: a retrospective population-based cohort analysis. The Lancet. Haematology, 6(1), e20-e28. https://doi.org/10.1016/S2352-3026(18)30191-1
Dawwas GK, et al. Effectiveness and Safety of Apixaban Versus Rivaroxaban for Prevention of Recurrent Venous Thromboembolism and Adverse Bleeding Events in Patients With Venous Thromboembolism: a Retrospective Population-based Cohort Analysis. Lancet Haematol. 2019;6(1):e20-e28. PubMed PMID: 30558988.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Effectiveness and safety of apixaban versus rivaroxaban for prevention of recurrent venous thromboembolism and adverse bleeding events in patients with venous thromboembolism: a retrospective population-based cohort analysis. AU - Dawwas,Ghadeer K, AU - Brown,Joshua, AU - Dietrich,Eric, AU - Park,Haesuk, Y1 - 2018/12/14/ PY - 2018/08/01/received PY - 2018/10/19/revised PY - 2018/10/24/accepted PY - 2018/12/19/pubmed PY - 2019/2/6/medline PY - 2018/12/19/entrez SP - e20 EP - e28 JF - The Lancet. Haematology JO - Lancet Haematol VL - 6 IS - 1 N2 - BACKGROUND: Apixaban and rivaroxaban, both direct-acting oral anticoagulants, are being increasingly used in routine clinical practice because of their fixed dosing and favourable pharmacological profiles. Differences in the risk of recurrent venous thromboembolism and major bleeding events between the two drugs are currently unknown. We aimed to compare the effectiveness and safety of apixaban and rivaroxaban in prevention of recurrent venous thromboembolism and major bleeding events in patients with venous thromboembolism. METHODS: We did a retrospective cohort analysis of data from the Truven Health MarketScan commercial and Medicare Supplement claims databases in the USA. We analysed data for adult patients with newly diagnosed venous thromboembolism (deep vein thrombosis or pulmonary embolism) who were new users of apixaban or rivaroxaban between Jan 1, 2014, and Dec 31, 2016. Patients who did not initiate the study drugs within 30 days of their diagnosis, those without 12 months of continuous enrolment in medical and pharmacy benefits, and those who used other anticoagulants during the baseline period were excluded. The primary effectiveness outcome was the incidence of recurrent venous thromboembolism and the primary safety outcome was the incidence of major bleeding events. Cox-proportional hazard models after propensity score matching were used to calculate the hazard ratio (HR) and 95% CI. FINDINGS: After propensity score matching, 15 254 patients were included in the cohort (3091 apixaban users and 12 163 rivaroxaban users). The crude incidence of recurrent venous thromboembolism was three per 100 person-years in the apixaban group and seven per 100 person-years in the rivaroxaban group. The incidence of major bleeding was three per 100 person-years in the apixaban group and six per 100 person-years in the rivaroxaban group. In multivariable Cox regression models, the use of apixaban compared with rivaroxaban was associated with decreased risk of recurrent venous thromboembolism (HR 0·37 [95% CI 0·24-0·55]; p<0·0001) and major bleeding events (0·54 [0·37-0·82]; p=0·0031). INTERPRETATION: Based on our findings, apixaban seems to be more effective than rivaroxaban in preventing the development of recurrent venous thromboembolism and major bleeding events. Our data might give some assurance to clinicians that apixaban can be an effective and safe therapeutic option for treatment of patients with venous thromboembolism. FUNDING: None. SN - 2352-3026 UR - https://www.unboundmedicine.com/medline/citation/30558988/Effectiveness_and_safety_of_apixaban_versus_rivaroxaban_for_prevention_of_recurrent_venous_thromboembolism_and_adverse_bleeding_events_in_patients_with_venous_thromboembolism:_a_retrospective_population_based_cohort_analysis_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S2352-3026(18)30191-1 DB - PRIME DP - Unbound Medicine ER -