Efficacy and safety of edoxaban versus enoxaparin for the prevention of venous thromboembolism following total hip arthroplasty: STARS J-V.
Efficacy and safety of edoxaban versus enoxaparin for the prevention of venous thromboembolism following total hip arthroplasty: STARS J-V.
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DOI：
10.1186/s12959-015-0057-x
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发表时间：
2015
影响因子：
3.1
通讯作者：
Tachibana S
中科院分区：
文献类型：
--
作者：
Fuji T;Fujita S;Kawai Y;Nakamura M;Kimura T;Fukuzawa M;Abe K;Tachibana S
在没有血栓预防的情况下，接受全髋关节置换术（THA）的患者发生静脉血栓栓塞（VTE）的风险增加。本研究的目的是比较依多沙班和依诺肝素在日本预防THA术后静脉血栓栓塞的疗效和安全性。这是一项三期、双盲、双假、非劣效性研究。选择性单侧原发性THA患者随机接受依多沙班30毫克每日1次（n = 307）或依诺肝素2000 IU（相当于20毫克）每日2次（n = 303），持续11至14天。主要疗效终点是静脉血栓栓塞的发生率。安全性终点包括大出血或临床相关的非大出血（CRNM）的发生率。静脉造影和临床监测显示，依多沙班组静脉血栓栓塞发生率为2.4%，依诺肝素组为6.9% （P <0.001）。静脉血栓栓塞发生率的绝对差异为- 4.5%(95%可信区间[CI]: - 8.6, - 0.9)，在8%的非劣效性范围内，建立了依多沙班对依诺肝素的非劣效性。由于绝对差异的95% CI上限小于0%，因此证明了依多沙班优于依诺肝素。依多沙班组大出血或CRNM出血发生率为2.6%，依诺肝素组为3.7% （P = 0.475）。口服依多沙班30毫克，每日1次，在预防静脉血栓栓塞方面优于皮下依诺肝素2000 IU，每日2次，且不会增加大出血或CRNM出血的风险。
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. 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. 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). 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.