Department of Vascular Medicine, Amsterdam Cardiovascular Sciences, Amsterdam Univesity Medical Center, University of Amsterdam, Amsterdam, the Netherlands; Amsterdam Cardiovascular Sciences, Pulmonary Hypertension and Thrombosis, Amsterdam, the Netherlands; Department of Internal Medicine, Tergooi MC, Hilversum, the Netherlands.
Department of Vascular Medicine, Amsterdam Cardiovascular Sciences, Amsterdam Univesity Medical Center, University of Amsterdam, Amsterdam, the Netherlands; Amsterdam Cardiovascular Sciences, Pulmonary Hypertension and Thrombosis, Amsterdam, the Netherlands.
J Thromb Haemost. 2024 Sep;22(9):2470-2481. doi: 10.1016/j.jtha.2024.05.031. Epub 2024 Jun 10.
Guidelines suggest indefinite anticoagulation after unprovoked venous thromboembolism (VTE) unless the bleeding risk is high, yet there is no consistent guidance on assessing bleeding risk.
This study aimed to evaluate the performance of 5 bleeding risk tools (RIETE, VTE-BLEED, CHAP, VTE-PREDICT, and ABC-Bleeding).
PLATO-VTE, a prospective cohort study, included patients aged ≥40 years with a first unprovoked VTE. Risk estimates were calculated at VTE diagnosis and after 3 months of treatment. Primary outcome was clinically relevant bleeding, as per International Society on Thrombosis and Haemostasis criteria, during 24-month follow-up. Discrimination was assessed by the area under the receiver operating characteristic curve (AUROC). Patients were classified as having a "high risk" and "non-high risk" of bleeding according to predefined thresholds; bleeding risk in both groups was compared by hazard ratios (HRs).
Of 514 patients, 38 (7.4%) had an on-treatment bleeding. AUROCs were 0.58 (95% CI, 0.48-0.68) for ABC-Bleeding, 0.56 (95% CI, 0.46-0.66) for RIETE, 0.53 (95% CI, 0.43-0.64) for CHAP, 0.50 (95% CI, 0.41-0.59) for VTE-BLEED, and 0.50 (95% CI, 0.40-0.60) for VTE-PREDICT. The proportion of high-risk patients ranged from 1.4% with RIETE to 36.9% with VTE-BLEED. The bleeding incidence in the high-risk groups ranged from 0% with RIETE to 13.0% with ABC-Bleeding, and in the non-high-risk groups, it varied from 7.7% with ABC-Bleeding to 9.6% with RIETE. HRs ranged from 0.93 (95% CI, 0.46-1.9) for VTE-BLEED to 1.67 (95% CI, 0.86-3.2) for ABC-Bleeding. Recalibration at 3-month follow-up did not alter the results.
In this cohort, discrimination of currently available bleeding risk tools was poor. These data do not support their use in patients with unprovoked VTE.
指南建议在没有高出血风险的情况下，对非诱因性静脉血栓栓塞症（VTE）患者进行无限期抗凝治疗，但目前尚无一致的出血风险评估指南。
本研究旨在评估 5 种出血风险工具（RETE、VTE-BLEED、CHAP、VTE-PREDICT 和 ABC-Bleeding）的性能。
PLATO-VTE 是一项前瞻性队列研究，纳入了年龄≥40 岁且首次发生无诱因 VTE 的患者。在 VTE 诊断时和治疗 3 个月时计算风险估计值。主要结局为 24 个月随访期间，根据国际血栓和止血学会（International Society on Thrombosis and Haemostasis）标准定义的临床相关出血。通过接收者操作特征曲线（receiver operating characteristic curve，ROC）下面积（area under the receiver operating characteristic curve，AUROC）评估区分度。根据预设阈值将患者分为“出血高风险”和“非高风险”组；通过风险比（hazard ratio，HR）比较两组的出血风险。
在 514 例患者中，38 例（7.4%）发生治疗期间出血。ABC-Bleeding、RETE、CHAP、VTE-BLEED 和 VTE-PREDICT 的 AUROC 分别为 0.58（95%CI，0.48-0.68）、0.56（95%CI，0.46-0.66）、0.53（95%CI，0.43-0.64）、0.50（95%CI，0.41-0.59）和 0.50（95%CI，0.40-0.60）。高风险患者的比例从 RIETE 的 1.4%到 VTE-BLEED 的 36.9%不等。高风险组的出血发生率从 RIETE 的 0%到 ABC-Bleeding 的 13.0%不等，而非高风险组的出血发生率从 ABC-Bleeding 的 7.7%到 RIETE 的 9.6%不等。HR 从 VTE-BLEED 的 0.93（95%CI，0.46-1.9）到 ABC-Bleeding 的 1.67（95%CI，0.86-3.2）不等。在 3 个月随访时进行重新校准并未改变结果。
在本队列中，目前可用的出血风险工具的区分度较差。这些数据不支持在无诱因 VTE 患者中使用这些工具。
