From the *Department of Epidemiology, School of Public Health, University of Alabama at Birmingham, Birmingham, Alabama; †Department of Neurology, University of Alabama at Birmingham, Birmingham, Alabama; ‡Department of Medicine, University of Alabama at Birmingham, Birmingham, Alabama; §Division of Cardiovascular Diseases, Department of Medicine, University of Alabama at Birmingham, Birmingham, Alabama; ¶Division of Cardiothoracic Surgery, Department of Surgery, University of Alabama at Birmingham, Birmingham, Alabama; ‖Department of Biostatistics, School of Public Health, University of Alabama at Birmingham, Birmingham, Alabama; and #Heart South Cardiovascular Group, Columbiana, Alabama.
ASAIO J. 2017 Nov/Dec;63(6):759-765. doi: 10.1097/MAT.0000000000000592.
Anticoagulation control has been associated with risk of thromboembolism and hemorrhage. Herein, we explore the relationship between anticoagulation control achieved in left ventricular assist device (LVAD) patients and evaluate the association with risk of thromboembolism and hemorrhage. Patients (19 years old or older) with a continuous flow LVAD placed from 2006 to 2012. Percent time spent in target range (PTTR) for international normalized ratio (INR) was estimated with target range of 2.0-3.0. Proportion of time spent in target range was categorized into PTTR > 60%, PTTR ≥ 50 < 60%, and PTTR < 50%. The relationship between PTTR and thromboembolism and hemorrhage was assessed. One hundred fifteen participants contributed 624.5 months of follow-up time. Only 20% of patients achieved anticoagulation control (PTTR > 60% for INR range of 2-3). After adjusting for chronic kidney disease, history of diabetes, history of atrial fibrillation, and age at implant, compared with patients with PTTR < 50%, the relative risk of thromboembolism in patients with PTTR ≥ 60% (hazard ratio [HR]: 0.37; 95% confidence interval [CI]: 0.14-0.96; p = 0.042) was significantly lower, but not for patients with a PTTR of ≥ 50 < 60% (HR: 0.21; 95% CI: 0.02-1.82; p = 0.16). The relative risk for hemorrhage was also significantly lower among patients with a PTTR ≥ 60% (HR: 0.45; 95% CI: 0.21-0.98; p = 0.045), but not among those with PTTR of ≥ 50 < 60% (HR: 0.47; 95% CI: 0.14-1.56; p = 0.22). This current study demonstrates that LVAD patients remain in the INR target range an average of 42.9% of the time. To our knowledge, this is the first report with regard to anticoagulation control as assessed by PTTR and its association with thromboembolism, hemorrhage, or death among patients with ventricular assist devices (VADs).
抗凝控制与血栓栓塞和出血风险相关。在此,我们探讨了左心室辅助装置 (LVAD) 患者中达到的抗凝控制与血栓栓塞和出血风险之间的关系。研究对象为 2006 年至 2012 年期间植入的连续血流 LVAD 患者(年龄≥19 岁)。国际标准化比值 (INR) 的目标范围时间百分比 (PTTR) 采用 INR 目标范围 2.0-3.0 进行估计。目标范围时间百分比分为 PTTR > 60%、PTTR≥50<60%和 PTTR<50%。评估了 PTTR 与血栓栓塞和出血的关系。115 名参与者共提供了 624.5 个月的随访时间。只有 20%的患者达到了抗凝控制(INR 范围在 2-3 时 PTTR>60%)。在调整了慢性肾脏病、糖尿病史、心房颤动史和植入年龄后,与 PTTR<50%的患者相比,PTTR≥60%的患者发生血栓栓塞的相对风险显著降低(风险比[HR]:0.37;95%置信区间[CI]:0.14-0.96;p=0.042),而 PTTR≥50<60%的患者则没有(HR:0.21;95%CI:0.02-1.82;p=0.16)。PTTR≥60%的患者出血的相对风险也显著降低(HR:0.45;95%CI:0.21-0.98;p=0.045),但 PTTR≥50<60%的患者则没有(HR:0.47;95%CI:0.14-1.56;p=0.22)。本研究表明,LVAD 患者的 INR 目标范围平均达到 42.9%。据我们所知,这是第一项关于 PTTR 评估的抗凝控制及其与心室辅助装置 (VAD) 患者的血栓栓塞、出血或死亡之间关系的报告。