title: Venous thromboembolism after total joint arthroplasty: results from a Japanese multicenter cohort study.
abstract: BACKGROUND
  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.
  
  
  METHODS
  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.
  
  
  BACKGROUND
  University Hospital Medical Information Network Clinical Trials Registry: UMIN000001366. Registered 11 September 2008.
authors.forename: Kiyoshi
authors.initials: K
authors.lastname: Migita
authors.forename: Seiji
authors.initials: S
authors.lastname: Bito
authors.forename: Mashio
authors.initials: M
authors.lastname: Nakamura
authors.forename: Shigeki
authors.initials: S
authors.lastname: Miyata
authors.forename: Masanobu
authors.initials: M
authors.lastname: Saito
authors.forename: Hirosi
authors.initials: H
authors.lastname: Kakizaki
authors.forename: Yuichiro
authors.initials: Y
authors.lastname: Nakayama
authors.forename: Tomohiro
authors.initials: T
authors.lastname: Matsusita
authors.forename: Itaru
authors.initials: I
authors.lastname: Furuichi
authors.forename: Yoshihiro
authors.initials: Y
authors.lastname: Sasazaki
authors.forename: Takaaki
authors.initials: T
authors.lastname: Tanaka
authors.forename: Mamoru
authors.initials: M
authors.lastname: Yoshida
authors.forename: Hironori
authors.initials: H
authors.lastname: Kaneko
authors.forename: Isao
authors.initials: I
authors.lastname: Abe
authors.forename: Takatomo
authors.initials: T
authors.lastname: Mine
authors.forename: Kazuhiko
authors.initials: K
authors.lastname: Ihara
authors.forename: Shigeyuki
authors.initials: S
authors.lastname: Kuratsu
authors.forename: Koichiro
authors.initials: K
authors.lastname: Saisho
authors.forename: Hisaaki
authors.initials: H
authors.lastname: Miyahara
authors.forename: Tateki
authors.initials: T
authors.lastname: Segata
authors.forename: Yasuaki
authors.initials: Y
authors.lastname: Nakagawa
authors.forename: Masataka
authors.initials: M
authors.lastname: Kamei
authors.forename: Takafumi
authors.initials: T
authors.lastname: Torigoshi
authors.forename: Satoru
authors.initials: S
authors.lastname: Motokawa
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000925:Anticoagulants / Q000627:therapeutic use*; D019643:Arthroplasty, Replacement / Q000009:adverse effects*; D015331:Cohort Studies; D017984:Enoxaparin / Q000627:therapeutic use; D005260:Female; D000077425:Fondaparinux; D006493:Heparin / Q000627:therapeutic use; D006801:Humans; D015994:Incidence; D007564:Japan; D008297:Male; D008875:Middle Aged; D010975:Platelet Aggregation Inhibitors / Q000627:therapeutic use; D011134:Polysaccharides / Q000627:therapeutic use; D011183:Postoperative Complications / Q000453:epidemiology / Q000517:prevention & control*; D012307:Risk Factors; D054556:Venous Thromboembolism / Q000453:epidemiology / Q000517:prevention & control*
chemical_list: D000925:Anticoagulants; D017984:Enoxaparin; D010975:Platelet Aggregation Inhibitors; D011134:Polysaccharides; D006493:Heparin; D000077425:Fondaparinux