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Original scientific paper

Rivaroxaban vs Dabigatran for Thromboprophylaxis After Joint-replacement Surgery: Exploratory Indirect Comparison Based on Metaanalysis of Pivotal Clinical Trials

Vladimir Trkulja ; Department of Pharmacology, Zagreb University School of Medicine, Zagreb, Croatia
Robert Kolundžić ; Department of Orthopedic Surgery, Zagreb University Hospital Center and School of Medicine, Zagreb, Croatia

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page 113-123

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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 20 618 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.


rivaroxaban, dabigatran, total arthroplasty, thromboprophylaxis

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