Background: Fondaparinux sodium has been compared with low-molecular-weight heparins (LMWH) in randomized controlled trials for perioperative surgical thromboprophylaxis. However, the results from these studies are inconsistent in terms of efficacy and safety to reach a clinical decision. The objective of this study was to systematically review the randomized controlled trials comparing the efficacy and safety of fondaparinux and LMWH for perioperative surgical thromboprophylaxis. Methods and Results: Systematic search in various databases was done to identify randomized controlled trials comparing fondaparinux and LMWH published during the years 2000 to 2017. Outcomes of interest in this study included venous thromboembolism up to day 15, all-cause mortality up to day 90, major bleeding, and minor bleeding during the treatment period. Analyses were performed with the relative odds based on a random-effects model using Mantel-Haenszel statistics. Results were presented as odds ratios with their 95% CIs. The assessment of study quality was performed as per Cochrane collaboration. After screening 10 644 articles, 12 randomized controlled trials including 14 906 patients were included in the final analyses. Pooled analyses showed the odds of venous thromboembolism in the fondaparinux group were 0.49 times the odds in LMWH group (OR=0.49 [0.38–0.64]). However, the odds of major bleeding in the fondaparinux group were 1.48 times the odds in the LMWH group (OR=1.48 [1.15–1.90]). Conclusions: Fondaparinux was associated with a superior efficacy in terms of reduction of venous thromboembolism in this meta-analysis. However, it was also associated with increased odds of major bleeding.
Bibliographical noteFunding Information:
This study represents original work. It was completed recently and has not been published elsewhere. All of the authors of this paper contributed to the work, contributed in preparation of the manuscript, and have provided their final approval for the manuscript submission. The authors thank Dr. Wendy St. Peter, Professor, University of Minnesota (College of Pharmacy) for her contribution in preparation of the manuscript.
- low molecular weight heparin
- systematic review
- venous thromboembolism