Bleeding risk and performance of bleeding risk assessment models in patients with venous thromboembolism on anticoagulation: results from the prospective observational bleeding and assess long-term outcomes on health in patients with venous thromboembolism (BACH-VTE) study.

IF 5 2区医学 Q1 HEMATOLOGY

Journal of Thrombosis and Haemostasis Pub Date : 2025-05-14 DOI:10.1016/j.jtha.2025.05.005

Timothy Hoberstorfer, Stephan Nopp, Daniel Steiner, Julia Deinsberger, Oliver Schlager, Ingrid Pabinger, Benedikt Weber, Cihan Ay

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引用次数: 0

Abstract

Background: Patients with venous thromboembolism (VTE) are at risk of bleeding during anticoagulation.

Objectives: This study aimed to assess bleeding risk and the performance of risk assessment models (RAMs) VTE-PREDICT, HAS-BLED, RIETE, and VTE-BLEED in patients with acute VTE initiating anticoagulation.

Methods: We used data from a prospective observational cohort study (BACH-VTE) including patients with acute VTE who initiated anticoagulation with a follow-up period of up to 2 years. Exclusion criteria were active cancer, pregnancy, and postpartum period. Major bleeding, clinically relevant nonmajor bleeding (CRNMB), and minor bleeding were recorded and their frequencies calculated. RAM performance was evaluated by discrimination and calibration. Predictors associated with clinically relevant bleeding (CRB; composite of major and CRNMB) were assessed.

Results: In total, 308 patients (median age, 55 years; 42% women, 47% pulmonary embolism, 62% unprovoked VTE) were included. During a median follow-up time of 12.6 months, we observed 2 major bleedings, 41 CRNMBs, and 66 minor bleedings, corresponding to 2-year cumulative incidences (95% CI) of 0.9% (0%-2.1%), 16.2% (10.7%-21.3%), and 20.6% (15.1%-25.8%), respectively, and of 33.4% (26.7-39.5) for any bleeding. RAM discrimination was poor to moderate with C-statistics (95% CI) for CRB of 0.71 (0.61-0.80) for VTE-PREDICT, 0.59 (0.49-0.68) for HAS-BLED, 0.52 (0.41-0.62) for RIETE, and 0.56 (0.45-0.68) for VTE-BLEED. Calibration analysis revealed underestimation of bleeding risk. Female sex, lower hemoglobin, and bleeding history were associated with CRB in a univariable but not in a multivariable model.

Conclusion: In patients treated with anticoagulants for VTE, we found high rates of CRB. Only the VTE-PREDICT model showed acceptable discrimination, but poor calibration.

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抗凝治疗静脉血栓栓塞患者出血风险及出血风险评估模型的性能：来自前瞻性BACH-VTE研究的结果。

背景：静脉血栓栓塞（VTE）患者在抗凝期间有出血的危险。目的：评估急性静脉血栓栓塞患者启动抗凝治疗的出血风险和风险评估模型（RAMs） VTE- predict、HAS-BLED、RIETE和VTE- bleed的性能。方法：我们利用了一项前瞻性观察队列研究（BACH-VTE）的数据，其中包括开始抗凝治疗的急性静脉血栓栓塞患者，随访时间长达两年。排除标准为活动性癌症、妊娠期和产后。记录大出血、临床相关非大出血（CRNMB）和轻微出血并计算其频率。通过判别和校准对RAM性能进行了评价。评估与临床相关出血（CRB， major和CRNMB的复合）相关的预测因素。结果：共纳入308例患者（中位年龄：55岁，42%为女性，47%为肺栓塞，62%为非诱发性静脉血栓栓塞）。在12.6个月的中位随访期间，我们观察到2例大出血、41例crnmb和66例轻微出血，对应的2年累积发生率（95% CI）分别为0.9%（0-2.1）、16.2%（10.7-21.3）和20.6%(15.1-25.8)，任何出血的发生率为33.4%（26.7-39.5）。RAM判别差至中等，cci为VTE-PREDICT的CRB为0.71(0.61-0.80)，哈斯- bled为0.59 (0.49-0.68)，RIETE为0.52 (0.41-0.62)，VTE-BLEED为0.56（0.45-0.68）。校准分析显示出血风险被低估。在单变量模型中，女性性别、低血红蛋白和出血史与CRB相关，而在多变量模型中则无关。结论：在静脉血栓栓塞抗凝治疗的患者中，我们发现CRB发生率较高。只有VTE-PREDICT模型具有可接受的判别性，但校准较差。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Journal of Thrombosis and Haemostasis 医学-外周血管病

CiteScore

24.30

自引率

3.80%

发文量

321

审稿时长

1 months

期刊介绍： The Journal of Thrombosis and Haemostasis (JTH) serves as the official journal of the International Society on Thrombosis and Haemostasis. It is dedicated to advancing science related to thrombosis, bleeding disorders, and vascular biology through the dissemination and exchange of information and ideas within the global research community. Types of Publications: The journal publishes a variety of content, including: Original research reports State-of-the-art reviews Brief reports Case reports Invited commentaries on publications in the Journal Forum articles Correspondence Announcements Scope of Contributions: Editors invite contributions from both fundamental and clinical domains. These include: Basic manuscripts on blood coagulation and fibrinolysis Studies on proteins and reactions related to thrombosis and haemostasis Research on blood platelets and their interactions with other biological systems, such as the vessel wall, blood cells, and invading organisms Clinical manuscripts covering various topics including venous thrombosis, arterial disease, hemophilia, bleeding disorders, and platelet diseases Clinical manuscripts may encompass etiology, diagnostics, prognosis, prevention, and treatment strategies.