Venous thromboembolism after total joint arthroplasty: results from a Japanese multicenter cohort study

Arthritis Research & Therapy, Jul 2014

Introduction 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. Method 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. Results 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). Conclusions These findings indicate that prophylaxis with fondaparinux, not enoxaparin, reduces the risk of DVT but increases bleeding tendency in patients undergoing TKA and THA. Trial registration University Hospital Medical Information Network Clinical Trials Registry: UMIN000001366. Registered 11 September 2008.

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Venous thromboembolism after total joint arthroplasty: results from a Japanese multicenter cohort study

Migita et al. Arthritis Research & Therapy Venous thromboembolism after total joint arthroplasty: results from a Japanese multicenter cohort study Kiyoshi Migita 0 2 3 Seiji Bito 2 3 Mashio Nakamura 2 3 Shigeki Miyata 2 3 Masanobu Saito 0 2 3 Hirosi Kakizaki 0 2 3 Yuichiro Nakayama 0 2 3 Tomohiro Matsusita 0 2 3 Itaru Furuichi 0 2 3 Yoshihiro Sasazaki 0 2 3 Takaaki Tanaka 0 2 3 Mamoru Yoshida 0 2 3 Hironori Kaneko 0 2 3 Isao Abe 0 2 3 Takatomo Mine 0 2 3 Kazuhiko Ihara 0 2 3 Shigeyuki Kuratsu 0 2 3 Koichiro Saisho 0 2 3 Hisaaki Miyahara 0 2 3 Tateki Segata 0 2 3 Yasuaki Nakagawa 0 2 3 Masataka Kamei 2 3 Takafumi Torigoshi 0 2 3 Satoru Motokawa 0 1 2 3 0 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 1 Department of Orthopedic Surgery, NHO Nagasaki Medical Center , Kubara 2-1001-1, Omura 856-8652 , Japan 2 CI , confidence interval; DVT, deep vein thrombosis; e-GFR, estimated glomerular filtrating ratio; PE, pulmonary embolism; THA, total hip arthroplasty 3 CI , confidence interval; DVT, deep vein thrombosis; e-GFR, estimated glomerular filtrating ratio; PE, pulmonary embolism; TKA, total knee arthroplasty Introduction: 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. Method: 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. Results: 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). Conclusions: These findings indicate that prophylaxis with fondaparinux, not enoxaparin, reduces the risk of DVT but increases bleeding tendency in patients undergoing TKA and THA. - Trial registration: University Hospital Medical Information Network Clinical Trials Registry: UMIN000001366. Registered 11 September 2008. Introduction Postoperative venous thromboembolism (VTE), consisting of deep vein thrombosis (DVT) and pulmonary embolism (PE), is a major life-threating complication in patients undergoing surgery [1]. Patients undergoing total hip and knee arthroplasty (THA and TKA, respectively) are at high risk of VTE [2]. In patients undergoing THA or TKA, thromboprophylaxis with low-molecular-weight heparin (LMWH) or factor Xa inhibitors is recommended for a minimum of 10 to 14 days up to 35 days in current evidence-based guidelines [3,4]. However, it is not clear whether these regimens affect important patient outcomes in real-world settings [5]. Despite the need for effective and safe thromboprophylactic drugs in patients undergoing joint replacement therapy, few real-world data assessed the benefits of anticoagulants in this population. The translation of evidence-based guidelines into everyday clinical practice is not immediate [6]. Adoption of these recommendations in patients undergoing elective orthopedic surgery depends on combinations of patient-associated factors, including age, gender, and comorbidities, and physician-a (...truncated)


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Kiyoshi Migita, Seiji Bito, Mashio Nakamura, Shigeki Miyata, Masanobu Saito, Hirosi Kakizaki, Yuichiro Nakayama, Tomohiro Matsusita, Itaru Furuichi, Yoshihiro Sasazaki, Takaaki Tanaka, Mamoru Yoshida, Hironori Kaneko, Isao Abe, Takatomo Mine, Kazuhiko Ihara, Shigeyuki Kuratsu, Koichiro Saisho, Hisaaki Miyahara, Tateki Segata, Yasuaki Nakagawa, Masataka Kamei, Takafumi Torigoshi, Satoru Motokawa. Venous thromboembolism after total joint arthroplasty: results from a Japanese multicenter cohort study, Arthritis Research & Therapy, 2014, pp. R154, 16, DOI: 10.1186/ar4616