Department of Pulmonary and Critical Care Medicine, Punan Hospital, Shanghai, China.
Department of Pulmonary and Critical Care Medicine, Xinhua Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China.
Clin Appl Thromb Hemost. 2024 Jan-Dec;30:10760296241246004. doi: 10.1177/10760296241246004.
Prothrombin time/international normalized ratio (PT/INR) is related to both antithrombotic effect and risk of bleeding. Its role in the prediction of venous thromboembolism (VTE) recurrence and bleeding for patients with acute VTE who undergo direct oral anticoagulants (DOACs) treatment is unclear, despite previous studies revealed some association between them. The predictive efficiency of INR for VTE recurrence and bleeding were analyzed in a retrospective cohort with VTE patients who underwent DOACs treatment. Then its predictive efficiency for VTE recurrence and bleeding were validated in a prospective cohort with the acquired cutoffs range, and compared with anti-Xa level, DASH and VTE-BLEED scores. In the retrospective cohort ( = 1083), the sensitivity and specificity of INR for the prediction of VTE recurrence were 79.4% and 92.8%, respectively. The area under the curve (AUC) was 0.881 (0.803-0.960)( = .025). The cutoff value of INR was 0.9. The sensitivity and specificity of INR for the prediction of bleeding were 85.7% and 77.9%, respectively. The AUC was 0.876 (0.786-0.967)( < .001). The cutoff value of INR was 2.1. In the prospective cohort ( = 202), the calibration showed that there were 4 (50%) patients with VTE recurrence, 156 (97.5%) patients with non-recurrence and bleeding (non-R&B), and 20 (58.8%) patients with bleeding in the low (INR < 0.9)( = 8), intermediate (0.9 ≤ INR ≤ 2.1)( = 160), and high (INR > 2.1)( = 34) groups, respectively. The baseline PT/INR value at the initiation of DOACs treatment is an independent predictor for VTE recurrence and bleeding in patients with acute VTE who undergo DOACs treatment.
凝血酶原时间/国际标准化比值(PT/INR)与抗栓作用和出血风险均相关。尽管此前的研究表明两者之间存在一定关联,但直接口服抗凝剂(DOAC)治疗的急性静脉血栓栓塞症(VTE)患者的 VTE 复发和出血中,PT/INR 对其的预测作用尚不清楚。本研究旨在通过回顾性队列分析 DOAC 治疗的 VTE 患者中,INR 对 VTE 复发和出血的预测效率,并通过前瞻性队列验证其在获得的截断值范围内对 VTE 复发和出血的预测效率,并与抗 Xa 水平、DASH 和 VTE-BLEED 评分进行比较。在回顾性队列(n=1083)中,INR 预测 VTE 复发的敏感性和特异性分别为 79.4%和 92.8%。曲线下面积(AUC)为 0.881(0.803-0.960)(P=0.025)。INR 的截断值为 0.9。INR 预测出血的敏感性和特异性分别为 85.7%和 77.9%。AUC 为 0.876(0.786-0.967)(P<0.001)。INR 的截断值为 2.1。在前瞻性队列(n=202)中,校准显示 VTE 复发的患者有 4 例(50%),非复发且无出血(非 R&B)的患者有 156 例(97.5%),INR<0.9(n=8)、0.9≤INR≤2.1(n=160)和 INR>2.1(n=34)组中出血的患者分别有 20 例(58.8%)。DOAC 治疗开始时的基线 PT/INR 值是 DOAC 治疗的急性 VTE 患者 VTE 复发和出血的独立预测因素。