Kye-Youl Cho1, Kang-Il Kim, Sumit Khurana, Dae-Kyung Bae, Wook Jin. 1. Department of Orthopaedic Surgery, Center for Joint Diseases and Rheumatism, Kyung Hee University Hospital at Gangdong, 892 Dongnam-ro, Gangdong-gu, Seoul, Korea.
Abstract
BACKGROUND: Standard thromboprophylaxis guidelines have not been applied universally in regions with low incidence of deep-vein thrombosis (DVT) considering risks of chemoprophylaxis and low incidence itself. We evaluated the prevalence of DVT, efficacy and safety of chemoprophylaxis, and necessity of pharmacological prevention in a low DVT incidence population. METHODS:One hundred and forty-eight patients undergoing unilateral total knee arthroplasty (TKA) were prospectively randomized to receive either a placebo or 2.5 mg of fondaparinux once daily for 5 days. Doppler ultrasonography was performed preoperatively and 7 days after surgery. The primary efficacy outcome was prevalence of DVT up to day 7. Secondary efficacy outcome was prevalence of symptomatic venous thromboembolism (VTE) up to day 90. Primary and secondary safety outcomes were incidence of major and minor bleeding, respectively. RESULTS: The prevalence of total DVT was 25.7 % in placebo group and 6.8 % in fondaparinux group (p = 0.002) and the prevalence of proximal DVT was lower in both groups with no statistical difference. There was no symptomatic VTE in either group up to day 90. Although no major bleeding was developed, fondaparinux group had a significant increase of minor bleeding events (p < 0.001). CONCLUSIONS: There remains low incidence of VTE following TKA in East Asians even without chemoprophylaxis. Although short-term fondaparinux protocol could reduce the incidence of overall DVT, its routine use seems debatable due to extremely rare proximal DVT and symptomatic PE and drug-related bleeding complication. However, modified and selective use of chemoprophylaxis would be considerable in high risk patients.
RCT Entities:
BACKGROUND: Standard thromboprophylaxis guidelines have not been applied universally in regions with low incidence of deep-vein thrombosis (DVT) considering risks of chemoprophylaxis and low incidence itself. We evaluated the prevalence of DVT, efficacy and safety of chemoprophylaxis, and necessity of pharmacological prevention in a low DVT incidence population. METHODS: One hundred and forty-eight patients undergoing unilateral total knee arthroplasty (TKA) were prospectively randomized to receive either a placebo or 2.5 mg of fondaparinux once daily for 5 days. Doppler ultrasonography was performed preoperatively and 7 days after surgery. The primary efficacy outcome was prevalence of DVT up to day 7. Secondary efficacy outcome was prevalence of symptomatic venous thromboembolism (VTE) up to day 90. Primary and secondary safety outcomes were incidence of major and minor bleeding, respectively. RESULTS: The prevalence of total DVT was 25.7 % in placebo group and 6.8 % in fondaparinux group (p = 0.002) and the prevalence of proximal DVT was lower in both groups with no statistical difference. There was no symptomatic VTE in either group up to day 90. Although no major bleeding was developed, fondaparinux group had a significant increase of minor bleeding events (p < 0.001). CONCLUSIONS: There remains low incidence of VTE following TKA in East Asians even without chemoprophylaxis. Although short-term fondaparinux protocol could reduce the incidence of overall DVT, its routine use seems debatable due to extremely rare proximal DVT and symptomatic PE and drug-related bleeding complication. However, modified and selective use of chemoprophylaxis would be considerable in high risk patients.