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

Abstract

BackgroundGuidelines 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.MethodsThis 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.ResultsAmong 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.ConclusionsAlthough 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 registrationClinicalTrials.gov Identifier: NCT01181102

Optimised fast‐track protocols in total knee arthroplasty determine shorter hospitalisation time and lower perioperative/postoperative complications

“…Mechanical thromboembolic prophylaxis is currently under debate, and many studies show contradictory results. Probably, a risk stratification among patients who undergo TKA might allow to reduce the use of chemical thromboprophylaxis, especially in patients with low thrombotic risk [11, 19].…”

“…Mechanical thromboembolic prophylaxis is currently under debate, and many studies show contradictory results. Probably, a risk stratification among patients who undergo TKA might allow to reduce the use of chemical thromboprophylaxis, especially in patients with low thrombotic risk [11,19]. This is the first systematic review reporting the best evidence-based clinical recommendations on some of the most discussed topics regarding perioperative management in TKA.…”

“…Studies concerning the use of compression stockings showed contradictory results. Indeed, a study by Fuji et al [11] concluded that the use of an anticoagulant plus graduated compression stockings (GCSs) in patients who underwent TKA showed more efficacy in preventing postoperative VTE compared with patients who received anticoagulation alone.…”

Graduated compression stockings in the prevention of postoperative pulmonary embolism. A propensity-matched retrospective case-control study of 24 273 patients

“…The analysis of Fuji et al of the Phase 3 Edoxaban study in Total Knee Arthroplasty describes post hoc the benefit of GCS when all VTEs (asymptomatic thrombosis, symptomatic thrombosis and pulmonary embolism) were included [ 31 ]. A total of 201 patients, divided into four groups, GCS with edoxaban or enoxaparin versus no GCS with edoxaban or enoxaparin were compared.…”

Medizinische Thromboseprophylaxestrümpfe – große Wirkung in Zulassungsstudien von Edoxaban

“…In der CLOTS-Studie mit neurologischen Patienten gab es unter hüftlangen MTPS zwar weniger proximale Thrombosen als unter knielangen MTPS, dafür aber mehr Hautläsionen[9]. -mal täglich 20 mg Enoxaparin (48 mit MTPS zusätzlich zu Enoxaparin und 48 nur mit Enoxaparin) erhielten, die Wirksamkeit der MTPS beurteilt werden[15]. ▶ Tab.…”