Dataset Information

Efficacy and safety of edoxaban versus enoxaparin for the prevention of venous thromboembolism following total hip arthroplasty: STARS J-V.

ABSTRACT: BACKGROUND:In the absence of thromboprophylaxis, patients undergoing total hip arthroplasty (THA) are at increased risk for venous thromboembolism (VTE). The objective of this study was to compare the efficacy and safety of edoxaban with enoxaparin for the prevention of VTE after THA in Japan. METHODS:This was a phase 3, double-blind, double-dummy, noninferiority study. Patients undergoing elective, unilateral primary THA were randomized to receive edoxaban 30 mg once daily (n?=?307) or enoxaparin 2000 IU (equivalent to 20 mg) twice daily (n?=?303) for 11 to 14 days. The primary efficacy endpoint was the incidence of VTE. Safety endpoints included the incidence of major or clinically relevant nonmajor (CRNM) bleeding. RESULTS:The incidence of VTE, based on venography and clinical surveillance, was 2.4 % in the edoxaban group and 6.9 % in the enoxaparin group (P <0.001). The absolute difference in the incidence of VTE was -4.5 % (95 % confidence interval [CI]: -8.6, -0.9), which was within the noninferiority margin set at 8 % for the difference and established the noninferiority of edoxaban to enoxaparin. Since the upper limit of the 95 % CI of the absolute difference was less than 0 %, the superiority of edoxaban over enoxaparin was demonstrated. The incidence of major or CRNM bleeding was 2.6 % in the edoxaban group and 3.7 % in the enoxaparin group (P?=?0.475). CONCLUSIONS:Oral edoxaban 30 mg once daily was superior to subcutaneous enoxaparin 2000 IU twice daily in the prevention of VTE following THA without increasing the risk for major or CRNM bleeding.

SUBMITTER: Fuji T

PROVIDER: S-EPMC4534125 | biostudies-literature | 2015

REPOSITORIES: biostudies-literature

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Efficacy and safety of edoxaban versus enoxaparin for the prevention of venous thromboembolism following total hip arthroplasty: STARS J-V.

Fuji Takeshi T Fujita Satoru S Kawai Yohko Y Nakamura Mashio M Kimura Tetsuya T Fukuzawa Masayuki M Abe Kenji K Tachibana Shintaro S

Thrombosis journal 20150812

<h4>Background</h4>In the absence of thromboprophylaxis, patients undergoing total hip arthroplasty (THA) are at increased risk for venous thromboembolism (VTE). The objective of this study was to compare the efficacy and safety of edoxaban with enoxaparin for the prevention of VTE after THA in Japan.<h4>Methods</h4>This was a phase 3, double-blind, double-dummy, noninferiority study. Patients undergoing elective, unilateral primary THA were randomized to receive edoxaban 30 mg once daily (n = 3 ...[more]

PMID: 26269694

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Project description:BackgroundThe objective of this analysis was to assess the effects of edoxaban compared with enoxaparin on key coagulation biomarkers and present pooled primary efficacy and safety results from phase 3 STARS E-3 and STARS J-V trials for prevention of venous thromboembolism (VTE) after total knee arthroplasty (TKA) or total hip arthroplasty (THA).MethodsIn the randomized, double-blind, double-dummy, multicenter, STARS E-3 and STARS J-V trials, patients received edoxaban 30 mg or enoxaparin 2000 IU (20 mg) twice daily for 11 to 14 days. The studies were conducted in Japan and Taiwan; enoxaparin dosing was based on Japanese label recommendations. The primary efficacy endpoint was incidence of VTE; the safety endpoint was major or clinically relevant nonmajor (CRNM) bleeding. Blood samples were taken at presurgical evaluation, pretreatment (postsurgery), predose on day 7, predose on completion of treatment, and at a follow-up examination 25 to 35 days after the last dose of study drug for D-dimer, prothrombin fragment 1 + 2 (F1+2), and soluble fibrin monomer complex (SFMC) measurement.ResultsA total of 716 patients enrolled in STARS E-3 and 610 patients enrolled in STARS J-V; 1326 patients overall. This analysis included 657 patients who received edoxaban 30 mg QD and 650 patients who received enoxaparin 20 mg BID. Incidence of VTE was 5.1 and 10.7% for edoxaban and enoxaparin, respectively (P <0.001). Incidence of combined major and CRNM bleeding was 4.6 and 3.7% for edoxaban and enoxaparin, respectively (P = 0.427). On day 7, mean D-dimer (4.4 vs 5.5 μg/mL), F1+2 (363 vs 463 pmol/L), and SFMC (5.7 vs 6.8 μg/mL) were lower in edoxaban-treated patients relative to enoxaparin-treated patients, respectively (P <0.0001 for all). At end of treatment, mean D-dimer (5.4 vs 6.2 μg/mL), F1+2 (292 vs 380 pmol/L), and SFMC (6.2 vs 7.2 μg/mL) were lower in edoxaban-treated patients relative to enoxaparin-treated patients (P <0.0001 for all).ConclusionsEdoxaban was superior to enoxaparin in prevention of VTE following TKA and THA, with comparable rates of bleeding events. Relative to enoxaparin, edoxaban significantly reduced D-dimer, F1+2, and SFMC.Trial registrationClintrials.gov NCT01181102 and NCT01181167. Both registered 8/12/2010.

Project description:BACKGROUND:There have been many efforts to find modifiable risk factors for venous thromboembolism (VTE) in the perioperative period of total knee arthroplasty (TKA), while no study has investigated the relationship between the muscle mass and deep vein thrombosis (DVT) or pulmonary embolism frequency following TKA. This study aimed to evaluate the relationship between muscle volume and the prevalence of symptomatic and radiologically confirmed venous thromboembolism (VTE) after total knee arthroplasty (TKA). METHODS:A total of 261 consecutive patients who underwent primary TKA between 2013 and 2015 were enrolled. Computed tomographic venography with pulmonary angiography (CTVPA) was performed between the 5th and 7th postoperative days to assess the presence of VTE. Four parameters of muscle volume at three levels were evaluated on CTVPA: (i) the cross-sectional area of all skeletal muscles (skeletal muscle index) and total psoas area at the level of the third lumbar vertebrae; (ii) the vastus lateralis muscle at the thigh level; and (iii) the posterior crural muscle at the lower leg level. The relationship between the muscle volume at each level and the prevalence of VTE after TKA was evaluated with multivariate adjusted logistic regression models. RESULTS:The CTVPA scan showed no proximal DVT, and all thrombi were located in muscular, peroneal, and posterior tibial veins. In unilateral TKA, patients with lower muscle volume of the vastus lateralis at the thigh level in the nonoperated limb had significantly higher prevalence of distal DVT in the operated limb (adjusted OR: 2.97 at subclinical DVT revealed by CTVPA and adjusted OR: 2.68 at symptomatic DVT). This finding was also discovered in patients who underwent simultaneous bilateral TKA (adjusted OR: 1.73-2.97 at subclinical DVT and adjusted OR:1.76-1.86 at symptomatic DVT). CONCLUSIONS:The relative muscle volume of the vastus lateralis at the thigh level was negatively associated with the prevalence of symptomatic and radiologically confirmed DVT, suggesting that low thigh muscle mass is an independent risk factor for VTE in the postoperative period of TKA.

Dataset Information

Efficacy and safety of edoxaban versus enoxaparin for the prevention of venous thromboembolism following total hip arthroplasty: STARS J-V.

Publications

Efficacy and safety of edoxaban versus enoxaparin for the prevention of venous thromboembolism following total hip arthroplasty: STARS J-V.

Similar Datasets

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