Thromb Haemost 2016; 115(03): 600-607
DOI: 10.1160/th15-07-0527
Coagulation and Fibrinolysis
Schattauer GmbH

Effect of oral factor Xa inhibitor and low-molecular-weight heparin on surgical complications following total hip arthroplasty

Sang-Min Kim
1   Department of Orthopaedic Surgery, Seoul Medical Center, Seoul, South Korea
,
Young-Wan Moon
2   Department of Orthopaedic Surgery, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea
,
Seung-Jae Lim
2   Department of Orthopaedic Surgery, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea
,
Dong-Wook Kim
2   Department of Orthopaedic Surgery, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea
,
Youn-Soo Park
2   Department of Orthopaedic Surgery, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea
› Author Affiliations
Further Information

Publication History

Received: 07 July 2015

Accepted after major revision: 22 January 2015

Publication Date:
20 March 2018 (online)

Summary

This prospective study was conducted to report the effect of oral factor Xa inhibitor and low-molecular-weight heparin (LMWH) on surgical complications following total hip arthroplasty (THA). The patients with an age < 60 years were randomly assigned to three groups (rivaroxaban, enoxaparin, and placebo) and the patients with an age ≥ 60 years were assigned to two groups (rivaroxaban and enoxaparin). All drug regimens started at 12 hours postoperatively and continued for two weeks after surgery. Primary measure outcome was major surgical wound complications defined as haematoma requiring any intervention, superficial wound infection, deep periprosthetic infection, and increased wound bleeding. Secondary measured outcome included minor surgical complications (swelling, drainage, erythema, and oozing), organ bleeding, and venous thromboembolic (VTE) events. A total of 184 patients aged < 60 years and 167 patients aged ≥ 60 years were included as the analysis population per group. Up to 14 days after surgery, the overall incidence of major surgical complications associated with thromboprophylaxis was 6.5 % (58/886). There were no significant differences in the rate of major surgical complications among all the three groups of the patients aged < 60 years and between two groups of the patients aged ≥ 60 years. For the patients aged < 60 years, wound oozing continued significantly longer in the pharmacological group than in the placebo group, but wound infection did not occur in any case. The VTE events were similar in all the groups.

 
  • References

  • 1 Geerts WH, Bergqvist D, Pineo GF. et al. Prevention of venous thromboembolism: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines (8th Edition). Chest 2008; 133: 381S-453S.
  • 2 Geerts WH, Pineo GF, Heit JA. et al. Prevention of venous thromboembolism: the Seventh ACCP Conference on Antithrombotic and Thrombolytic Therapy. Chest 2004; 126: 338S-400S.
  • 3 Bergqvist D, Arcelus JI, Felicissimo P. et al. Post-discharge compliance to venous thromboembolism prophylaxis in high-risk orthopaedic surgery: results from the ETHOS registry. Thromb Haemost 2012; 107: 280-287.
  • 4 Bergqvist D, Arcelus JI, Felicissimo P. et al. Evaluation of the duration of throm-boembolic prophylaxis after high-risk orthopaedic surgery: the ETHOS observational study. Thromb Haemost 2012; 107: 270-279.
  • 5 Sobieraj DM, Coleman CI, Tongbram V. et al. Comparative effectiveness of low-molecular-weight heparins versus other anticoagulants in major orthopedic surgery: a systematic review and meta-analysis. Pharmacotherapy 2012; 32: 799-808.
  • 6 Falck-Ytter Y, Francis CW, Johanson NA. et al. Prevention of VTE in orthopedic surgery patients: Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. Chest 2012; 141: e278S-325S.
  • 7 Mont MA, Jacobs JJ, Boggio LN. et al. Preventing venous thromboembolic disease in patients undergoing elective hip and knee arthroplasty. J Am Acad Orthop Surg 2011; 19: 768-776.
  • 8 Kinov P, Tanchev PP, Ellis M. et al. Antithrombotic prophylaxis in major orthopaedic surgery: an historical overview and update of current recommendations. Int Orthop 2014; 38: 169-175.
  • 9 Committee R-MW, Ginsberg JS, Davidson BL. et al. Oral thrombin inhibitor dabigatran etexilate vs North American enoxaparin regimen for prevention of venous thromboembolism after knee arthroplasty surgery. J Arthroplasty 2009; 24: 1-9.
  • 10 Eriksson BI, Borris LC, Friedman RJ. et al. Rivaroxaban versus enoxaparin for thromboprophylaxis after hip arthroplasty. N Engl J Med 2008; 358: 2765-2775.
  • 11 Eriksson BI, Dahl OE, Rosencher N. et al. Oral dabigatran etexilate vs. subcutaneous enoxaparin for the prevention of venous thromboembolism after total knee replacement: the RE-MODEL randomized trial. J Thromb Haemost 2007; 5: 2178-2185.
  • 12 Eriksson BI, Dahl OE, Rosencher N. et al. Dabigatran etexilate versus enoxapa-rin for prevention of venous thromboembolism after total hip replacement: a randomised, double-blind, non-inferiority trial. Lancet 2007; 370: 949-956.
  • 13 Kakkar AK, Brenner B, Dahl OE. et al. Extended duration rivaroxaban versus short-term enoxaparin for the prevention of venous thromboembolism after total hip arthroplasty: a double-blind, randomised controlled trial. Lancet 2008; 372: 31-39.
  • 14 Lassen MR, Ageno W, Borris LC. et al. Rivaroxaban versus enoxaparin for thromboprophylaxis after total knee arthroplasty. N Engl J Med 2008; 358: 2776-2786.
  • 15 Lassen MR, Gallus A, Raskob GE. et al. Apixaban versus enoxaparin for throm-boprophylaxis after hip replacement. N Engl J Med 2010; 363: 2487-2498.
  • 16 Lassen MR, Raskob GE, Gallus A. et al. Apixaban versus enoxaparin for throm-boprophylaxis after knee replacement (ADVANCE-2): a randomised doubleblind trial. Lancet 2010; 375: 807-815.
  • 17 Lassen MR, Raskob GE, Gallus A. et al. Apixaban or enoxaparin for thrombo-prophylaxis after knee replacement. N Engl J Med 2009; 361: 594-604.
  • 18 Turpie AG, Lassen MR, Davidson BL. et al. Rivaroxaban versus enoxaparin for thromboprophylaxis after total knee arthroplasty (RECORD4): a randomised trial. Lancet 2009; 373: 1673-1680.
  • 19 As-Sultany M, Pagkalos J, Yeganeh S. et al. Use of oral direct factor Xa inhibiting anticoagulants in elective hip and knee arthroplasty: a meta-analysis of efficacy and safety profiles compared with those of low-molecular-weight heparins. Curr Vasc Pharmacol 2013; 11: 366-375.
  • 20 Dahl OE, Quinlan DJ, Bergqvist D. et al. A critical appraisal of bleeding events reported in venous thromboembolism prevention trials of patients undergoing hip and knee arthroplasty. J Thromb Haemost 2010; 8: 1966-1975.
  • 21 Bloch BV, Patel V, Best AJ. Thromboprophylaxis with dabigatran leads to an increased incidence of wound leakage and an increased length of stay after total joint replacement. Bone Joint J 2014; 96-B: 122-126.
  • 22 Gill SK, Theodorides A, Smith N. et al. Wound problems following hip arthro-plasty before and after the introduction of a direct thrombin inhibitor for thromboprophylaxis. Hip Int 2011; 21: 678-683.
  • 23 Jensen CD, Steval A, Partington PF. et al. Return to theatre following total hip and knee replacement, before and after the introduction of rivaroxaban: a retrospective cohort study. J Bone Joint Surg Br 2011; 93: 91-95.
  • 24 Park Y. Guideline for the prophylaxis of venous thromboembolism in hip surgery patients. Korean Orthop Assoc 2014; 46: 95-98.
  • 25 Colwell Jr. CW, Berkowitz SD, Lieberman JR. et al. Oral direct thrombin inhibitor ximelagatran compared with warfarin for the prevention of venous thromboembolism after total knee arthroplasty. J Bone Joint Surg Am 2005; 87: 2169-2177.
  • 26 Koulouvaris P, Sculco P, Finerty E. et al. Relationship between perioperative urinary tract infection and deep infection after joint arthroplasty. Clin Orthop Relat Res 2009; 467: 1859-1867.
  • 27 Colwell Jr. CW, Froimson MI, Mont MA. et al. Thrombosis prevention after total hip arthroplasty: a prospective, randomized trial comparing a mobile compression device with low-molecular-weight heparin. J Bone Joint Surg Am 2010; 92: 527-535.
  • 28 Sobieraj DM, Lee S, Coleman CI. et al. Prolonged versus standard-duration venous thromboprophylaxis in major orthopedic surgery: a systematic review. Ann Intern Med 2012; 156: 720-727.