Clinic for Thoracic and Cardiovascular Surgery, Heart Center North Rhine-Westphalia, Ruhr University Bochum, Bad Oeynhausen, Germany.
Ann Thorac Surg. 2010 Nov;90(5):1487-93. doi: 10.1016/j.athoracsur.2010.06.069.
Self-management improves oral anticoagulation control. Here we provide data of a preplanned interim analysis of very low-dose early self-controlled anticoagulation.
In a prospective, randomized, multicenter trial, 1,137 patients performed low-dose international normalized ratio (INR) self-management with a target INR range of 1.8. to 2.8 for aortic valve replacement recipients and 2.5 to 3.5 for mitral or double valve replacement recipients for the first six postoperative months. Thereafter, 379 patients continued to achieve the aforementioned INR target range (LOW group), whereas the INR target value was set at 2.0 (range, 1.6 to 2.1) for the remaining patients with aortic valve replacement and 2.3 (range, 2.0 to 2.5) for the remaining patients with mitral valve or double valve replacement. One half of this latter group had to check their INR values once a week (VL1 group) the other half twice a week (VL2 group). Patients were followed up for 24 months.
Beyond study month six, the incidence of thromboembolic events that required hospital admission was 0.58%, 0.0%, and 0.58% in the LOW, VL1, and VL2 groups, respectively (p = 0.368). The incidence of bleeding events per patient-year was 1.16%, 1.07%, and 0.58% in the LOW, VL1, and VL2 groups, respectively (p = 0.665). Mortality rate did not differ among study groups.
Data demonstrate the efficacy and safety of very low-dose INR self-management.
自我管理可改善口服抗凝治疗控制效果。在此，我们提供了预先设定的极低剂量早期自我控制抗凝的分析结果。
在一项前瞻性、随机、多中心试验中，1137 例主动脉瓣置换患者和 1137 例二尖瓣或双瓣置换患者术后前 6 个月接受低剂量国际标准化比值（INR）自我管理，目标 INR 范围分别为 1.8 至 2.8 和 2.5 至 3.5。此后，379 例患者继续达到上述 INR 目标范围（LOW 组），而其余主动脉瓣置换患者的 INR 目标值设定为 2.0（范围为 1.6 至 2.1），其余二尖瓣或双瓣置换患者的 INR 目标值设定为 2.3（范围为 2.0 至 2.5）。后者组的一半患者需要每周检查一次 INR 值（VL1 组），另一半患者需要每两周检查一次（VL2 组）。患者随访 24 个月。
在研究第六个月后，需要住院的血栓栓塞事件发生率分别为 LOW、VL1 和 VL2 组的 0.58%、0.0%和 0.58%（p = 0.368）。每例患者每年出血事件的发生率分别为 LOW、VL1 和 VL2 组的 1.16%、1.07%和 0.58%（p = 0.665）。各组之间的死亡率无差异。
数据表明极低剂量 INR 自我管理的疗效和安全性。
