Koertke Heinrich, Zittermann Armin, Minami Kazutomo, Tenderich Gero, Wagner Otto, El-Arousy Mahmoud, Krian Arno, Ennker Juergen, Taborski Uwe, Klövekorn Wolf Peter, Moosdorf Rainer, Saggau Werner, Morshuis Michiel, Koerfer Jan, Seifert Dirk, Koerfer Reiner
Department of Thoracic and Cardiovascular Surgery, Heart and Diabetes Center North-Rhine-Westphalia Bad Oeynhausen, Germany Clinic, Ruhr University Bochum, Bochum, Germany.
Ann Thorac Surg. 2005 Jun;79(6):1909-14; discussion 1914. doi: 10.1016/j.athoracsur.2004.09.012.
International normalized ratio (INR) self-management can significantly reduce INR fluctuations, bleeding, and thromboembolic events compared with INR control managed by general practitioners. However, even patients with INR self-management may have an increased risk of bleeding if their INR value is above 3.5. This study evaluated the compliance, clinical complications, and survival of patients after mechanical heart valve replacement with low-dose INR self-management compared with conventional-dose anticoagulation.
Group 1 (n = 908) received low-dose anticoagulation with a target INR range of 1.8 to 2.8 for aortic valve replacement and 2.5 to 3.5 for mitral or double valve replacement. Group 2 (n = 910) received conventional-dose anticoagulation with a target INR range of 2.5 to 4.5 for all heart valve prostheses.
In groups 1 and 2, 76% and 75% of INR values, respectively, were in the target range. Results did not differ according to schooling and age. The rate of thromboembolic events per patient year was 0.18% in group 1 and 0.40% in group 2 (p = 0.210). The rate of bleeding complications was 0.74% for group 1 and 1.20% for group 2 (p = 0.502). In most patients with clinically relevant bleeding, these complications occurred although their measured INR values were below 3.5. The survival rate did not differ between the study groups (p = 0.495).
Low-dose INR self-management is a promising tool to achieve low hemorrhagic complications without increasing the risk of thromboembolic complications. INR self-management is applicable for all patients in whom permanent anticoagulation therapy is indicated. Even INR values below 3.5 can bear the risk of bleeding complications.
与由全科医生管理的国际标准化比值（INR）控制相比，INR自我管理可显著降低INR波动、出血和血栓栓塞事件。然而，即使是进行INR自我管理的患者，如果其INR值高于3.5，出血风险也可能增加。本研究评估了与传统剂量抗凝相比，机械心脏瓣膜置换术后患者进行低剂量INR自我管理的依从性、临床并发症和生存率。
第1组（n = 908）接受低剂量抗凝，主动脉瓣置换的目标INR范围为1.8至2.8，二尖瓣或双瓣膜置换为2.5至3.5。第2组（n = 910）接受传统剂量抗凝，所有心脏瓣膜假体的目标INR范围为2.5至4.5。
在第1组和第2组中，分别有76%和75%的INR值处于目标范围内。结果在受教育程度和年龄方面没有差异。第1组患者每年的血栓栓塞事件发生率为0.18%，第2组为0.40%（p = 0.210）。第1组的出血并发症发生率为0.74%，第2组为1.20%（p = 0.502）。在大多数有临床相关出血的患者中，尽管其测量的INR值低于3.5，但仍发生了这些并发症。研究组之间的生存率没有差异（p = 0.495）。
低剂量INR自我管理是一种有前景的工具，可在不增加血栓栓塞并发症风险的情况下实现低出血并发症。INR自我管理适用于所有需要长期抗凝治疗的患者。即使INR值低于3.5也可能有出血并发症的风险。
