Clinical benefit of graduated compression stockings for prevention of venous thromboembolism after total knee arthroplasty: post hoc analysis of a phase 3 clinical study of edoxaban

Takeshi Fuji, Satoru Fujita, Tetsuya Kimura, Kei Ibusuki, Kenji Abe, Shintaro Tachibana, Mashio Nakamura, Takeshi Fuji, Satoru Fujita, Tetsuya Kimura, Kei Ibusuki, Kenji Abe, Shintaro Tachibana, Mashio Nakamura

Abstract

Background: Guidelines from the Japanese Circulation Society recommend prophylaxis with anticoagulation plus intermittent pneumatic compression or graduated compression stockings (GCS) among patients at the highest risk for developing venous thromboembolism (VTE). However, the benefits of concomitant GCS use for patients undergoing total knee arthroplasty (TKA) and receiving anticoagulation remain unknown. In this study, the efficacy of GCS plus anticoagulation compared with anticoagulation alone was evaluated among patients undergoing TKA.

Methods: This study is a post hoc analysis of a previously reported phase 3 trial involving patients undergoing TKA. In the primary study, which permitted the use of GCS for mechanical prophylaxis, patients were randomized to receive edoxaban 30 mg once daily or enoxaparin 20 mg twice daily for 11 to 14 days following TKA. The primary endpoint was the incidence of VTE, a composite of symptomatic deep vein thrombosis (DVT), symptomatic pulmonary embolism (PE), and asymptomatic DVT. Treatment comparisons were performed using the chi-square test, and the 95 % confidence intervals were calculated.

Results: Among patients receiving edoxaban, the incidence of VTE was 3.8 and 5.8 % for patients with and without GCS, respectively. For patients receiving enoxaparin, VTE incidence was 8.4 and 20.8 % among those with and without GCS, respectively. Overall, VTE incidence was 6.0 and 13.0 % for anticoagulated patients with and without GCS mechanical prophylaxis, respectively. No deaths or symptomatic PE were reported during this study.

Conclusions: Although the incidence of VTE was >2-fold lower among patients receiving anticoagulation plus GCS compared with those receiving anticoagulation alone, statistical significance was not achieved. Further studies are required to confirm the findings of this preliminary analysis.

Trial registration: ClinicalTrials.gov Identifier: NCT01181102.

Keywords: DVT; Deep vein thrombosis; Edoxaban; Enoxaparin; Graduated compression stockings; Intermittent pneumatic compression; Orthopedic surgery; Total knee arthroplasty; VTE; Venous thromboembolism.

Figures

Fig. 1
Fig. 1
Study design (phase 3 total knee arthroplasty study) [4]. aTreatment with oral edoxaban commenced 6–24 h postoperatively. bTreatment with subcutaneous enoxaparin commenced 24–36 h postoperatively. cFollow-up occurred 25–35 days after the last administered dose

References

    1. JCS Joint Working Group Guidelines for the diagnosis, treatment and prevention of pulmonary thromboembolism and deep vein thrombosis (JCS 2009) Circ J. 2011;75(5):1258–81. doi: 10.1253/circj.CJ-88-0010.
    1. Anderson FA, Spencer FA. Risk factors for venous thromboembolism. Circulation. 2003;107(23 suppl 1):I-9–I-16.
    1. Laryea J, Champagne B. Venous thromboembolism prophylaxis. Clin Colon Rectal Surg. 2013;26(3):153–9. doi: 10.1055/s-0033-1351130.
    1. Fuji T, Wang CJ, Fujita S, Kawai Y, Nakamura M, Kimura T, et al. Safety and efficacy of edoxaban, an oral factor Xa inhibitor, versus enoxaparin for thromboprophylaxis after total knee arthroplasty: the STARS E-3 trial. Thromb Res. 2014;134(6):1198–204. doi: 10.1016/j.thromres.2014.09.011.
    1. Fuji T, Fujita S, Kawai Y, Nakamura M, Kimura T, Fukuzawa M, et al. Efficacy and safety of edoxaban versus enoxaparin for the prevention of venous thromboembolism following total hip arthroplasty: STARS J-V. Thromb J. 2015;13:27. doi: 10.1186/s12959-015-0057-x.
    1. Fuji T, Fujita S, Kawai Y, Nakamura M, Kimura T, Kiuchi Y, et al. Safety and efficacy of edoxaban in patients undergoing hip fracture surgery. Thromb Res. 2014;133(6):1016–22. doi: 10.1016/j.thromres.2014.03.009.
    1. Clexane® for Subcutaneous Injection Kit 2000 IU. Tokyo, Japan: Sanofi-Aventis K.K; 2012 [Package Insert (Ver. 8), in Japanese].
    1. Turpie AG, Esmon C. Venous and arterial thrombosis-pathogenesis and the rationale for anticoagulation. Thromb Haemost. 2011;105(4):586. doi: 10.1160/TH10-10-0683.
    1. Sachdeva A, Dalton M, Amaragiri SV, Lees T. Elastic compression stockings for prevention of deep vein thrombosis. Cochrane Database Syst Rev. 2010;7:CD001484.
    1. Kalodiki EP, Hoppensteadt DA, Nicolaides AN, Fareed J, Gill K, Regan F, et al. Deep venous thrombosis prophylaxis with low molecular weight heparin and elastic compression in patients having total hip replacement. A randomised controlled trial. Int Angiol. 1996;15(2):162–8.
    1. Ohlund C, Fransson SG, Starck SA. Calf compression for prevention of thromboembolism following hip surgery. Acta Orthop Scand. 1983;54(6):896–9. doi: 10.3109/17453678308992929.

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