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Pregled bibliografske jedinice broj: 555934

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


Trkulja, Vladimir; Kolundžić, Robert
Rivaroxaban vs dabigatran for thromboprophylaxis after joint-replacement surgery : exploratory indirect comparison based on meta-analysis of pivotal clinical trials // Croatian Medical Journal, 51 (2010), 2; 113-123 (međunarodna recenzija, članak, znanstveni)


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

Autori
Trkulja, Vladimir ; Kolundžić, Robert

Izvornik
Croatian Medical Journal (0353-9504) 51 (2010), 2; 113-123

Vrsta, podvrsta i kategorija rada
Radovi u časopisima, članak, znanstveni

Ključne riječi
Rivaroxaban ; dabigatran ; thromboprophylaxis ; joint replacement ; surgery

Sažetak
Aim was 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. 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. 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. 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.

Izvorni jezik
Engleski

Znanstvena područja
Kliničke medicinske znanosti



POVEZANOST RADA


Projekt / tema
108-1080233-0157 - Hrvatski registar endoproteza (Miroslav Smerdelj, )

Ustanove
Medicinski fakultet, Zagreb,
Sveučilište Libertas

Profili:

Avatar Url Robert Kolundžić (autor)

Avatar Url Vladimir Trkulja (autor)

Citiraj ovu publikaciju

Trkulja, Vladimir; Kolundžić, Robert
Rivaroxaban vs dabigatran for thromboprophylaxis after joint-replacement surgery : exploratory indirect comparison based on meta-analysis of pivotal clinical trials // Croatian Medical Journal, 51 (2010), 2; 113-123 (međunarodna recenzija, članak, znanstveni)
Trkulja, V. & Kolundžić, R. (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), 113-123.
@article{article, year = {2010}, pages = {113-123}, keywords = {Rivaroxaban, dabigatran, thromboprophylaxis, joint replacement, surgery}, journal = {Croatian Medical Journal}, volume = {51}, number = {2}, issn = {0353-9504}, title = {Rivaroxaban vs dabigatran for thromboprophylaxis after joint-replacement surgery : exploratory indirect comparison based on meta-analysis of pivotal clinical trials}, keyword = {Rivaroxaban, dabigatran, thromboprophylaxis, joint replacement, surgery} }

Časopis indeksira:


  • Current Contents Connect (CCC)
  • Web of Science Core Collection (WoSCC)
    • Science Citation Index Expanded (SCI-EXP)
    • SCI-EXP, SSCI i/ili A&HCI
  • Scopus
  • MEDLINE





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