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Dabigatran, rivaroxaban, or apixaban versus enoxaparin for thromboprophylaxis after total hip or knee replacement: systematic review, meta-analysis, and indirect treatment comparisons.

Gómez-Outes A, Terleira-Fernández AI, Suárez-Gea ML, Vargas-Castrillón E - BMJ (2012)

Bottom Line: The treatments did not differ on the net clinical endpoint in direct or indirect comparisons.A higher efficacy of new anticoagulants was generally associated with a higher bleeding tendency.The new anticoagulants did not differ significantly for efficacy and safety.

View Article: PubMed Central - PubMed

Affiliation: Division of Pharmacology and Clinical Evaluation, Medicines for Human Use, Spanish Agency for Medicines and Medical Devices, Parque Empresarial Las Mercedes, Madrid, Spain. agomezo@aemps.es

ABSTRACT

Objective: To analyse clinical outcomes with new oral anticoagulants for prophylaxis against venous thromboembolism after total hip or knee replacement.

Design: Systematic review, meta-analysis, and indirect treatment comparisons.

Data sources: Medline and CENTRAL (up to April 2011), clinical trials registers, conference proceedings, and websites of regulatory agencies.

Study selection: Randomised controlled trials of rivaroxaban, dabigatran, or apixaban compared with enoxaparin for prophylaxis against venous thromboembolism after total hip or knee replacement. Two investigators independently extracted data. Relative risks of symptomatic venous thromboembolism, clinically relevant bleeding, deaths, and a net clinical endpoint (composite of symptomatic venous thromboembolism, major bleeding, and death) were estimated using a random effect meta-analysis. RevMan and ITC software were used for direct and indirect comparisons, respectively.

Results: 16 trials in 38,747 patients were included. Compared with enoxaparin, the risk of symptomatic venous thromboembolism was lower with rivaroxaban (relative risk 0.48, 95% confidence interval 0.31 to 0.75) and similar with dabigatran (0.71, 0.23 to 2.12) and apixaban (0.82, 0.41 to 1.64). Compared with enoxaparin, the relative risk of clinically relevant bleeding was higher with rivaroxaban (1.25, 1.05 to 1.49), similar with dabigatran (1.12, 0.94 to 1.35), and lower with apixaban (0.82, 0.69 to 0.98). The treatments did not differ on the net clinical endpoint in direct or indirect comparisons.

Conclusions: A higher efficacy of new anticoagulants was generally associated with a higher bleeding tendency. The new anticoagulants did not differ significantly for efficacy and safety.

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Related in: MedlinePlus

Fig 3 Clinically relevant bleeding
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fig3: Fig 3 Clinically relevant bleeding

Mentions: Rivaroxaban was associated with a significant increase in risk of clinically relevant bleeding (relative risk 1.25, 95% confidence interval 1.05 to 1.49; P=0.01) (fig 3). Dabigatran did not show a significant increase compared with enoxaparin (1.12, 0.94 to 1.35; P=0.21). The risk was similar in the comparison of dabigatran 220 mg with enoxaparin (1.12, 0.92 to 1.38; P=0.26) and dabigatran 150 mg with enoxaparin (1.12, 0.89 to 1.40; P=0.34). On the contrary, apixaban was associated with a significantly reduced risk of clinically relevant bleeding compared with enoxaparin (0.82, 0.69 to 0.98; P=0.03). No evidence of statistical heterogeneity was found for this outcome among studies comparing rivaroxaban, dabigatran, or apixaban with enoxaparin (fig 3).


Dabigatran, rivaroxaban, or apixaban versus enoxaparin for thromboprophylaxis after total hip or knee replacement: systematic review, meta-analysis, and indirect treatment comparisons.

Gómez-Outes A, Terleira-Fernández AI, Suárez-Gea ML, Vargas-Castrillón E - BMJ (2012)

Fig 3 Clinically relevant bleeding
© Copyright Policy - open-access
Related In: Results  -  Collection

License 1 - License 2
Show All Figures
getmorefigures.php?uid=PMC3375207&req=5

fig3: Fig 3 Clinically relevant bleeding
Mentions: Rivaroxaban was associated with a significant increase in risk of clinically relevant bleeding (relative risk 1.25, 95% confidence interval 1.05 to 1.49; P=0.01) (fig 3). Dabigatran did not show a significant increase compared with enoxaparin (1.12, 0.94 to 1.35; P=0.21). The risk was similar in the comparison of dabigatran 220 mg with enoxaparin (1.12, 0.92 to 1.38; P=0.26) and dabigatran 150 mg with enoxaparin (1.12, 0.89 to 1.40; P=0.34). On the contrary, apixaban was associated with a significantly reduced risk of clinically relevant bleeding compared with enoxaparin (0.82, 0.69 to 0.98; P=0.03). No evidence of statistical heterogeneity was found for this outcome among studies comparing rivaroxaban, dabigatran, or apixaban with enoxaparin (fig 3).

Bottom Line: The treatments did not differ on the net clinical endpoint in direct or indirect comparisons.A higher efficacy of new anticoagulants was generally associated with a higher bleeding tendency.The new anticoagulants did not differ significantly for efficacy and safety.

View Article: PubMed Central - PubMed

Affiliation: Division of Pharmacology and Clinical Evaluation, Medicines for Human Use, Spanish Agency for Medicines and Medical Devices, Parque Empresarial Las Mercedes, Madrid, Spain. agomezo@aemps.es

ABSTRACT

Objective: To analyse clinical outcomes with new oral anticoagulants for prophylaxis against venous thromboembolism after total hip or knee replacement.

Design: Systematic review, meta-analysis, and indirect treatment comparisons.

Data sources: Medline and CENTRAL (up to April 2011), clinical trials registers, conference proceedings, and websites of regulatory agencies.

Study selection: Randomised controlled trials of rivaroxaban, dabigatran, or apixaban compared with enoxaparin for prophylaxis against venous thromboembolism after total hip or knee replacement. Two investigators independently extracted data. Relative risks of symptomatic venous thromboembolism, clinically relevant bleeding, deaths, and a net clinical endpoint (composite of symptomatic venous thromboembolism, major bleeding, and death) were estimated using a random effect meta-analysis. RevMan and ITC software were used for direct and indirect comparisons, respectively.

Results: 16 trials in 38,747 patients were included. Compared with enoxaparin, the risk of symptomatic venous thromboembolism was lower with rivaroxaban (relative risk 0.48, 95% confidence interval 0.31 to 0.75) and similar with dabigatran (0.71, 0.23 to 2.12) and apixaban (0.82, 0.41 to 1.64). Compared with enoxaparin, the relative risk of clinically relevant bleeding was higher with rivaroxaban (1.25, 1.05 to 1.49), similar with dabigatran (1.12, 0.94 to 1.35), and lower with apixaban (0.82, 0.69 to 0.98). The treatments did not differ on the net clinical endpoint in direct or indirect comparisons.

Conclusions: A higher efficacy of new anticoagulants was generally associated with a higher bleeding tendency. The new anticoagulants did not differ significantly for efficacy and safety.

Show MeSH
Related in: MedlinePlus