Koertke Heinrich, Zittermann Armin, Wagner Otto, Koerfer Reiner
Department of Cardiothoracic Surgery, Heart Center North-Rhine-Westphalia Bad Oeynhausen, Clinic of the Ruhr University Bochum, Germany.
Ann Thorac Surg. 2007 Jan;83(1):24-9. doi: 10.1016/j.athoracsur.2006.08.036.
The Early Self-Controlled Anticoagulation Trial has demonstrated that in patients with mechanical heart valve replacement self-management of oral anticoagulation results in less major thromboembolic events than conventional measurement by the general practitioner. However, the effects of self-management on long-term survival are currently not known.
Nine hundred thirty patients participated in a follow-up study of the aforementioned trial (488 from the self-management group and 442 from the conventional group). Long-term survival was assessed 12 years after the study began using the intent-to treat analysis as well as the per protocol analysis. Univariate and multivariate analyses were performed in order to assess independent predictors of survival.
In total, the 930 patients accrued 8,315 patient-years of observation. During follow-up, 236 patients died. According to the intent-to treat analysis, 10-year survival was 76.1% in the conventional group and 84.5% in the self-management group. The corresponding values for the per protocol analysis were 67.7% and 80.6%, respectively. Age, kind of valve surgery, and study group were independent predictors of survival. Self-management of oral anticoagulation increased long-term survival by 23% (intent-to-treat analysis) and 33% (per protocol analysis), respectively, compared with conventional measurement by the general practitioner. Possible reasons for these advantageous results in the self-management group are fewer thromboembolic events due to a higher percentage of international normalized ratio values lying in the target range compared with the conventional group.
Data indicate that self-management of oral anticoagulation is a promising strategy in order to increase long-term survival in patients with mechanical prosthetic valves.
早期自我控制抗凝试验表明,对于接受机械心脏瓣膜置换术的患者,口服抗凝药物的自我管理比由全科医生进行的传统测量方法导致的严重血栓栓塞事件更少。然而,自我管理对长期生存的影响目前尚不清楚。
930名患者参与了上述试验的随访研究(自我管理组488名,传统组442名)。在研究开始12年后,采用意向性分析和符合方案分析评估长期生存情况。进行单因素和多因素分析以评估生存的独立预测因素。
930名患者总共积累了8315人年的观察数据。随访期间,236名患者死亡。根据意向性分析,传统组的10年生存率为76.1%,自我管理组为84.5%。符合方案分析的相应值分别为67.7%和80.6%。年龄、瓣膜手术类型和研究组是生存的独立预测因素。与全科医生进行的传统测量相比,口服抗凝药物的自我管理分别使长期生存率提高了23%(意向性分析)和33%(符合方案分析)。自我管理组出现这些有利结果的可能原因是,与传统组相比,国际标准化比值处于目标范围内的百分比更高,血栓栓塞事件更少。
数据表明,口服抗凝药物的自我管理是提高机械人工瓣膜置换患者长期生存率的一种有前景的策略。