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

doi:10.1186/s12959-016-0087-z

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

Thromb J. 2016 Jun 8:14:13. doi: 10.1186/s12959-016-0087-z. eCollection 2016.

Authors

Takeshi Fuji¹, Satoru Fujita², Tetsuya Kimura³, Kei Ibusuki³, Kenji Abe⁴, Shintaro Tachibana⁵, Mashio Nakamura⁶

Affiliations

¹ Department of Orthopedic Surgery, Japan Community Healthcare Organization Osaka Hospital, 4-2-78 Fukushima, Fukushima-ku, Osaka 553-0003 Japan.
² Department of Orthopedic Surgery, Takarazuka Daiichi Hospital, 19-5 Kogetsu-cho, Takarazuka, 665-0832 Japan.
³ Daiichi Sankyo Co., Ltd., 3-5-1, Nihonbashi Honcho, Chuo-ku, Tokyo, 103-8426 Japan.
⁴ Clinical Data and Biostatistics Department, Daiichi Sankyo Co., Ltd., 1-2-58, Hiromachi, Shinagawa-ku, Tokyo, 140-8710 Japan.
⁵ Department of Orthopedic Surgery, Mishuku Hospital, 5-33-12 Shimomeguro, Meguro-ku, Tokyo, 153-0051 Japan.
⁶ Department of Cardiology and Nephrology, Mie University Graduate School of Medicine, 2-174 Edobashi, Tsu, Tsu, 514-8507 Mie Japan.

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.

Associated data

ClinicalTrials.gov/NCT01181102