Bové Thierry, Van Belleghem Yves, François Katrien, Caes Frank, De Pauw Michel, Taeymans Yves, Van Nooten Guido J
Heart Center, University Hospital Ghent, Ghent, Belgium.
University Ghent, Ghent, Belgium.
Interact Cardiovasc Thorac Surg. 2017 Jun 1;24(6):862-868. doi: 10.1093/icvts/ivx028.
To investigate the long-term results of a low international normalized ratio (INR)-anticoagulation program in selected patients after aortic valve replacement (AVR) with the Medtronic Open Pivot mechanical heart valve (OPMHV).
From January 1993 to December 2012, 909 OPMHV valves were used for single AVR. Patients with preserved sinus rhythm and left ventricular function (Low-INR, n = 552), were managed to an INR of 1.5-2.5 and compared to patients (Standard-INR, n = 357) treated with standard anticoagulation (INR 2.5-3.5). Long-term outcome was analysed for survival and valve-related events, on propensity score matched pairs of 169 patients/group.
Within a follow-up cumulating 3096 patient-years, 10- and 15-year survival was significantly better for Low-INR patients: 79% and 63% vs 63% and 34% ( P < 0.001). Multivariate analysis of late mortality identified older age [odds ratio (OR) = 1.05], chronic pulmonary disease (OR = 1.90) and coronary artery disease (OR = 1.57) as patient-related risk factors, and erratic INR (OR = 2.57) as anticoagulation-related factor. The linearized thromboembolic rate was 0.72%/patient-year in Low-INR patients, vs 0.87%/patient-year in Standard-INR patients ( P = 0.59), revealing INR variability as sole predictor (OR 3.54, 95% confidence interval (CI) 1.20-10.51, P = 0.022). The linearized bleeding incidence was respectively 0.61%/patient-year and 1.21%/patient-year for Low-INR and Standard-INR patients ( P = 0.04), retaining older age (OR 1.06, 95% CI 1.02-1.12, P = 0.009), hypertension (OR 2.06, 95% CI 1.00-4.25, P = 0.05) and erratic INR (OR 9.83, 95% CI 5.21-18.56, P < 0.001) as independent risk factors.
This study demonstrated that application of an anticoagulation regimen, aiming a low INR, individualized to selected aortic OPMHV patients, is safe and effective over more than 20 years, without increasing the thromboembolic complication rate while lowering the haemorrhagic events. However, INR variability remains worrisome because of its deleterious effect on outcome.
研究采用美敦力开放枢轴机械心脏瓣膜（OPMHV）行主动脉瓣置换术（AVR）的特定患者中低国际标准化比值（INR）抗凝方案的长期效果。
从1993年1月至2012年12月，909枚OPMHV瓣膜用于单例AVR。窦性心律和左心室功能保留的患者（低INR组，n = 552），将INR控制在1.5 - 2.5，并与接受标准抗凝治疗（INR 2.5 - 3.5）的患者（标准INR组，n = 357）进行比较。对倾向评分匹配的每组169例患者的生存和瓣膜相关事件进行长期结局分析。
在累积3096患者年的随访中，低INR患者的10年和15年生存率显著更高：分别为79%和63%，而标准INR患者为63%和34%（P < 0.001）。晚期死亡率的多变量分析确定年龄较大[比值比（OR）= 1.05]、慢性肺病（OR = 1.90）和冠状动脉疾病（OR = 1.57）为患者相关危险因素，INR不稳定（OR = 2.57）为抗凝相关因素。低INR患者的线性化血栓栓塞率为0.72%/患者年，标准INR患者为0.87%/患者年（P = 0.59），显示INR变异性是唯一预测因素（OR 3.54，95%置信区间（CI）1.20 - 10.51，P = 0.022）。低INR和标准INR患者的线性化出血发生率分别为0.61%/患者年和1.21%/患者年（P = 0.04），年龄较大（OR 1.06，95% CI 1.02 - 1.12，P = 0.009）、高血压（OR 2.06，95% CI 1.00 - 4.25，P = 0.05）和INR不稳定（OR 9.83，95% CI 5.21 - 18.56，P < 0.001）为独立危险因素。
本研究表明，针对特定的主动脉OPMHV患者采用低INR的个体化抗凝方案，在20多年里是安全有效的，在降低出血事件的同时不会增加血栓栓塞并发症发生率。然而，INR变异性因其对结局的有害影响仍然令人担忧。
