Wurnig Christian, Clemens Andreas, Rauscher Helmuth, Kleine Eva, Feuring Martin, Windhager Reinhard, Grohs Josef
Orthopaedisches Spital, Speisinger Strasse 109, 1130 Vienna, Austria.
Center for Thrombosis and Hemostasis, University Medical Center Mainz, Mainz, Germany ; Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim am Rhein, Germany.
Thromb J. 2015 Nov 26;13:37. doi: 10.1186/s12959-015-0066-9. eCollection 2015.
The aim of this study was to assess the safety and efficacy of switching therapy from low molecular weight heparin (LMWH; enoxaparin) to dabigatran for prevention of venous thromboembolic events (VTE) in patients undergoing elective total hip or knee replacement surgery (THR/TKR).
This was a prospective, multicenter, open-label, single-arm, observational, study in patients undergoing THR or TKR who were to receive enoxaparin 40 mg for thromboprophylaxis. Enoxaparin was initiated before or after surgery according to local practice, and was switched to dabigatran 220 mg once daily at a time point chosen by the investigator. The coprimary endpoints were major bleeding events, and the composite of symptomatic VTE and all-cause mortality, from last use of enoxaparin to 24 h after last intake of dabigatran.
Altogether, 168 (81 THR, 87 TKR) patients were enrolled, of whom 161 received both enoxaparin and dabigatran, 2 received dabigatran only and 5 received enoxaparin only. The median time of the first dabigatran tablet was 24.0 h after the last LMWH dosage and the median number of days on dabigatran treatment was 36 days. No symptomatic VTE or death occurred during the study. One major bleeding event was seen at the surgical site and required treatment cessation. Three minor bleeding events were observed.
In the normal clinical setting, switching from LMWH to dabigatran in patients who had undergone THR and TKR was safe and effective in preventing VTE. The reported adverse events and serious adverse events were consistent with the known safety profile for dabigatran. Switching from a subcutaneous to an oral anticoagulant may offer greater convenience in the outpatient setting after discharge.
ClinicalTrials.gov identifier NCT01153698.
本研究旨在评估在接受择期全髋关节或膝关节置换手术（THR/TKR）的患者中，从低分子量肝素（LMWH；依诺肝素）转换为达比加群用于预防静脉血栓栓塞事件（VTE）的安全性和有效性。
这是一项针对接受THR或TKR且接受40mg依诺肝素进行血栓预防的患者的前瞻性、多中心、开放标签、单臂观察性研究。依诺肝素根据当地实践在手术前或手术后开始使用，并在研究者选择的时间点转换为每日一次220mg达比加群。共同主要终点是从最后一次使用依诺肝素到最后一次摄入达比加群后24小时的主要出血事件，以及有症状VTE和全因死亡率的复合终点。
总共纳入了168例患者（81例THR，87例TKR），其中161例同时接受了依诺肝素和达比加群，2例仅接受了达比加群，5例仅接受了依诺肝素。首次服用达比加群片的中位时间是在最后一次LMWH剂量后24.0小时，达比加群治疗的中位天数是36天。研究期间未发生有症状的VTE或死亡。在手术部位观察到1例主要出血事件，需要停止治疗。观察到3例轻微出血事件。
在正常临床环境中，接受THR和TKR的患者从LMWH转换为达比加群在预防VTE方面是安全有效的。报告的不良事件和严重不良事件与达比加群已知的安全性特征一致。从皮下抗凝剂转换为口服抗凝剂可能在出院后的门诊环境中提供更大的便利。
ClinicalTrials.gov标识符NCT01153698。
