Venous thromboembolism after total joint arthroplasty: results from a Japanese multicenter cohort study
1 Japanese National Hospital Organization (NHO)-EBM study group; Japanese study of Prevention and Actual situation of Venous Thromboembolism after Total Arthroplasty (J-PSVT), Higashigaoka 2-5-21, Meguro, Tokyo 152-8621, Japan
2 Division of Clinical Epidemiology, NHO Tokyo Medical Center, Higashigaoka 2-5-1, Meguro, Tokyo 152-8902, Japan
3 Department of Clinical Cardiovascular Research, Mie University Graduate School of Medicine, Edohashi 2-174, Tsu, Mie 514-8507, Japan
4 Division of Transfusion Medicine, National Cerebral and Cardiovascular Center, Fujishirodai 5-7-1, Suita, Osaka 565-8565, Japan
5 Department of Anesthesiology, National Cerebral and Cardiovascular Center, Fujishirodai 5-7-1, Suita, Osaka 565-8565, Japan
6 Department of Orthopedic Surgery, NHO Nagasaki Medical Center, Kubara 2-1001-1, Omura, 856-8652, Japan
Arthritis Research & Therapy 2014, 16:R154 doi:10.1186/ar4616Published: 21 July 2014
Real-world evidence of the effectiveness of pharmacological thromboprophylaxis for venous thromboembolism (VTE) is limited. Our objective was to assess the effectiveness and safety of thromboprophylactic regimens in Japanese patients undergoing joint replacement in a real-world setting.
Overall, 1,294 patients (1,073 females and 221 males) who underwent total knee arthroplasty (TKA) and 868 patients (740 females and 128 males) who underwent total hip arthroplasty (THA) in 34 Japanese national hospital organization (NHO) hospitals were enrolled. The primary efficacy outcome was the incidence of deep vein thrombosis (DVT) detected by mandatory bilateral ultrasonography up to post-operative day (POD) 10 and pulmonary embolism (PE) up to POD28. The main safety outcomes were bleeding (major or minor) and death from any cause up to POD28.
Patients undergoing TKA (n = 1,294) received fondaparinux (n = 360), enoxaparin (n = 223), unfractionated heparin (n = 72), anti-platelet agents (n = 45), or no medication (n = 594). Patients undergoing THA (n = 868) received fondaparinux (n = 261), enoxaparin (n = 148), unfractionated heparin (n = 32), anti-platelet agents (n = 44), or no medication (n = 383). The incidence rates of sonographically diagnosed DVTs up to POD10 were 24.3% in patients undergoing TKA and 12.6% in patients undergoing THA, and the incidence rates of major bleeding up to POD28 were 1.2% and 2.3%, respectively. Neither fatal bleeding nor fatal pulmonary embolism occurred. Significant risk factors for postoperative VTE identified by multivariate analysis included gender (female) in both TKA and THA groups and use of a foot pump in the TKA group. Only prophylaxis with fondaparinux reduced the occurrence of VTE significantly in both groups. Propensity score matching analysis (fondaparinux versus enoxaparin) showed that the incidence of DVT was lower (relative risk 0.70, 95% confidence interval (CI) 0.58 to 0.85, P = 0.002 in TKA and relative risk 0.73, 95% CI 0.53 to 0.99, P = 0.134 in THA) but that the incidence of major bleeding was higher in the fondaparinux than in the enoxaparin group (3.4% versus 0.5%, P = 0.062 in TKA and 4.9% versus 0%, P = 0.022 in THA).
These findings indicate that prophylaxis with fondaparinux, not enoxaparin, reduces the risk of DVT but increases bleeding tendency in patients undergoing TKA and THA.
University Hospital Medical Information Network Clinical Trials Registry: UMIN000001366. Registered 11 September 2008.