Rivaroxaban vs dabigatran for thromboprophylaxis after joint-replacement surgery: exploratory indirect comparison based on meta-analysis of pivotal clinical trials

Trkulja, Vladimir and Kolundžić, Robert (2010) Rivaroxaban vs dabigatran for thromboprophylaxis after joint-replacement surgery: exploratory indirect comparison based on meta-analysis of pivotal clinical trials. Croatian Medical Journal, 51 (2). pp. 113-23. ISSN 0353-9504

[img]
Preview
PDF
Download (547kB) | Preview
Official URL: http://www.cmj.hr

Abstract

AIM: To indirectly compare rivaroxaban and dabigatran for prevention of venous thromboembolism (VTE) after total hip or knee arthroplasty (THA, TKA) based on their pivotal efficacy/safety trials embracing a total of 20618 patients. ----- METHODS: Pooled risk differences (RD) for rivaroxaban vs enoxaparin and dabigatran vs enoxaparin obtained from separate meta-analyses of two sets of trials were used to indirectly estimate RDs for rivaroxaban vs dabigatran. ----- RESULTS: Primary efficacy (any VTE+all-cause mortality) and safety (major bleeding) outcomes in enoxaparin arms largely differed across similarly designed rivaroxaban and dabigatran trials (differences in venography adjudication and bleeding events definitions). However, incidence of symptomatic VTE and incidence of major/non-major clinically relevant bleeding (including surgical site) were consistent in this respect. RDs (as percentages) for symptomatic VTE were: rivaroxaban-enoxaparin=-0.4% (95% confidence interval [CI], -0.9 to 0.05); dabigatran-enoxaparin=-0.09% (95% CI, -1.0 to 0.8); rivaroxaban-dabigatran=-0.3% (95% CI, -1.3 to 0.7; P=0.275). RDs for major/clinically relevant bleeding were rivaroxaban-enoxaparin=0.99% (95%CI, 0.29 to 1.69); dabigatran-enoxaparin=0.02% (95% CI, -1.0 to 1.0); rivaroxaban-dabigatran=0.97 (95% CI, -0.43 to 2.37; P=0.085). Mortality rates (all-cause, VTE-related, bleeding-related) were very low not indicating differences between any two of the three treatments. ----- CONCLUSION: Methodological differences disable indirect comparisons of rivaroxaban vs dabigatran that would be based on major efficacy/safety outcomes of their pivotal trials. The two drugs do not seem to differ regarding incidence of symptomatic VTE. Risk of a relevant bleeding is higher with rivaroxaban than with enoxaparin and the same tendency exists also vs dabigatran. Direct rivaroxaban vs dabigatran comparisons in this setting are needed.

Item Type: Article
Departments: Katedra za farmakologiju
Depositing User: Marijan Šember
Status: Published
Creators:
CreatorsEmail
Trkulja, VladimirUNSPECIFIED
Kolundžić, RobertUNSPECIFIED
Date: 15 April 2010
Date Deposited: 23 Apr 2010
Last Modified: 23 Sep 2011 16:11
Subjects: /
Related URLs:
    URI: http://medlib.mef.hr/id/eprint/748

    Actions (login required)

    View Item View Item

    Downloads

    Downloads per month over past year