癌症患者复发性静脉血栓栓塞和大出血的预测因素：CANVAS试验的次级分析

Predictors of recurrent venous thromboembolism and major bleeding in patients with cancer: A secondary analysis of the CANVAS trial

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THROMBOSIS RESEARCH

影响因子:3.4

分区:医学3区 / 血液学2区外周血管病3区

发表日期:2024 Dec

作者: Hajime Uno, Hong Xiong, Christine Cronin, Deborah Schrag, Jean M Connors

DOI: 10.1016/j.thromres.2024.109184

摘要

癌症患者发生静脉血栓栓塞（VTE）的风险增加，但在抗凝治疗下，复发性VTE和出血的风险也高于没有癌症的抗凝患者。CANVAS是一项随机的务实效果试验，比较了新型直接口服抗凝药物与低分子量肝素治疗癌症患者的新发VTE。此次预先设定的次级分析旨在识别癌症伴新VTE患者中复发性VTE和大出血的预测因素。分析对象包括671名参与者的资料，用于识别在6个月治疗期内复发性VTE和出血的预测因素。在单变量模型中显著的预测因素被纳入多变量模型，以确认两者的独立预测因素。复发性VTE的独立预测因素包括ECOG性能状态≥2（风险比HR为3.19[95%置信区间CI：1.45-7.02]，P<.005）、转移性疾病的存在（HR为2.57[95% CI：1.14-5.80]，P=.023）、使用贝伐单抗（HR为2.50[95% CI：1.04-5.99]，P=.041）以及以深静脉血栓而非肺栓塞作为首次VTE的患者（HR为1.86[95% CI：1.04-3.33]，P=.037）。大出血的独立预测因素包括血清白蛋白<3.5 g/dL（HR为1.97[95% CI：1.02-3.79]，P=.044）和转移性疾病（HR为2.80[95% CI：1.08-7.22]，P=.034）。这项在CANVAS试验中的预设次级分析结果揭示了癌症伴新VTE患者中复发性VTE和大出血的危险因素，反映了当前肿瘤临床实践。研究结果可用于临床中识别高风险患者，并为制定新的风险预测模型以改善患者护理提供依据。

Abstract

Patients with cancer have an increased risk of developing venous thromboembolism (VTE) but also have an increased risk of both recurrent VTE and bleeding with anticoagulation compared to anticoagulated patients without cancer. CANVAS, a randomized pragmatic effectiveness trial, compared the direct oral anticoagulants a class to low molecular weight heparin for treatment of a new VTE in patients with cancer. The aim of this prespecified secondary analysis of the CANVAS trial is to identify predictors of both recurrent VTE and major bleeding in patients with cancer and new VTE.Data from the 671 participants in the analysis population were used to identify predictors of recurrent VTE and bleeding during the 6-month treatment period. Significant predictors identified in the univariable models were carried forward in the multivariable models to identify independent predictors of both risks.Independent predictors of recurrent VTE include ECOG performance status ≥2 (HR, 3.19 [95 % CI, 1.45-7.02]; P < .005), presence of metastatic disease (HR, 2.57 [95 % CI, 1.14-5.80]; P = .023), treatment with bevacizumab (HR, 2.50 [95 % CI, 1.04-5.99]; P = .041), and deep vein thrombosis without pulmonary embolus as index VTE (HR, 1.86 [95 % CI, 1.04-3.33]; P = .037). Independent predictors of major bleeding include serum albumin <3.5 g/dL (HR 1.97 [95 % CI, 1.02-3.79]; P = .044) and metastatic disease (HR 2.80 [95 % CI, 1.08-7.22]; P = .034).Findings from this pre-specified analysis of the CANVAS trial identified risk factors for recurrent VTE and major bleeding in a population of participants with cancer and new VTE that reflect current oncology clinical practice. Results can be used to identify at risk patients in practice and inform new risk prediction models to improve the care of these patients.