Mair Helmut, Sachweh Jörg, Sodian Ralf, Brenner Paolo, Schmoeckel Michael, Schmitz Christoph, Reichart Bruno, Daebritz Sabine
Department of Cardiac Surgery, University Hospital Grosshadern, Ludwig-Maximilians-University, Munich, Germany.
Interact Cardiovasc Thorac Surg. 2012 Mar;14(3):253-7. doi: 10.1093/icvts/ivr088. Epub 2011 Dec 7.
In this investigation, we hypothesize that quality of oral anticoagulation (OA) and long-term outcome after mechanical heart valve (MHV) replacement with self-management (Self-M) of OA is superior to conventional anticoagulation treatment (Conv-T), even in outside trial conditions. One hundred sixty patients (78.8% aortic valve replacements) were trained in international normalized ratio Self-M and 260 patients (86.2% aortic valve replacements) preferred Conv-T. Mean follow-up was 8.6 ± 2.1 years, representing 3612 patient-years. During follow-up, 37.2% bleedings and 10.6% thromboembolic events were recorded in the Self-M group versus 39.6% bleedings (P = 0.213) and 15.4% thromboembolic events (P = 0.064) in the Conv-T group. Serious adverse events were significantly lower in the Self-M group [grade III bleeding events causing disability or death: 0 versus 4.6% (P = 0.03); grade III thromboembolic events: 0.6 versus 5.0% (P = 0.011)]. Patients with Self-M were significantly more satisfied with their OA management and their quality of life (P < 0.001). Actuarial survival after 1, 5 and 10 years was 100, 99 and 97 with Self-M and 100, 95 and 81% with Conv-T, respectively (P < 0.001). Univariate risk factors for mortality were age (P = 0.008), type of operation (P = 0.021) and conventional OA (P < 0.001). In multivariate analysis, only conventional OA reached significance (P < 0.001). We conclude that in a routine setting under outside trial conditions Self-M of OA improves long-term outcome and treatment quality.
在本研究中，我们假设即使在非试验条件下，口服抗凝治疗（OA）的质量以及机械心脏瓣膜（MHV）置换术后采用自我管理（Self-M）的OA的长期预后也优于传统抗凝治疗（Conv-T）。160例患者（78.8%为主动脉瓣置换术）接受了国际标准化比值自我管理培训，260例患者（86.2%为主动脉瓣置换术）选择了Conv-T。平均随访时间为8.6±2.1年，共3612患者年。随访期间，Self-M组记录到37.2%的出血事件和10.6%的血栓栓塞事件，而Conv-T组分别为39.6%的出血事件（P = 0.213）和15.4%的血栓栓塞事件（P = 0.064）。Self-M组的严重不良事件显著更低[导致残疾或死亡的III级出血事件：0比4.6%（P = 0.03）；III级血栓栓塞事件：0.6比5.0%（P = 0.011）]。采用Self-M的患者对其OA管理和生活质量的满意度显著更高（P < 0.001）。Self-M组1年、5年和10年的精算生存率分别为100%、99%和97%，Conv-T组分别为100%、95%和81%（P < 0.001）。死亡的单因素风险因素为年龄（P = 0.008）、手术类型（P = 0.021）和传统OA（P < 0.001）。在多因素分析中，只有传统OA具有统计学意义（P < 0.001）。我们得出结论，在非试验条件下的常规环境中，OA的自我管理可改善长期预后和治疗质量。
