研究动态
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癌症患者复发性静脉血栓栓塞和大出血的预测因素:CANVAS 试验的二次分析。

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

发表日期:2024 Oct 13
作者: Hajime Uno, Hong Xiong, Christine Cronin, Deborah Schrag, Jean M Connors
来源: THROMBOSIS RESEARCH

摘要:

与接受抗凝治疗的非癌症患者相比,接受抗凝治疗的癌症患者发生静脉血栓栓塞 (VTE) 的风险增加,但复发性 VTE 和出血的风险也增加。 CANVAS 是一项随机实用有效性试验,将直接口服抗凝剂 A 类与低分子量肝素治疗癌症患者的新 VTE 进行比较。 CANVAS 试验的这项预先指定的二次分析的目的是确定癌症患者和新发 VTE 患者复发性 VTE 和大出血的预测因素。分析人群中 671 名参与者的数据用于确定复发性 VTE 和出血的预测因素。 6个月的治疗期。在单变量模型中确定的重要预测因素在多变量模型中得到延续,以确定两种风险的独立预测因素。复发性 VTE 的独立预测因素包括 ECOG 体力状态 ≥2(HR,3.19 [95% CI,1.45-7.02];P <。 005),存在转移性疾病(HR,2.57 [95% CI,1.14-5.80];P = .023),贝伐单抗治疗(HR,2.50 [95% CI,1.04-5.99];P = .041),以及不以肺栓塞为指标的深静脉血栓形成 VTE(HR,1.86 [95% CI,1.04-3.33];P = .037)。大出血的独立预测因子包括血清白蛋白 <3.5 g/dL(HR 1.97 [95% CI,1.02-3.79];P = 0.044)和转移性疾病(HR 2.80 [95% CI,1.08-7.22];P =。 034). CANVAS 试验的这项预先指定的分析结果确定了癌症和新发 VTE 参与者群体中复发性 VTE 和大出血的危险因素,反映了当前肿瘤学临床实践。结果可用于在实践中识别高危患者,并为新的风险预测模型提供信息,以改善对这些患者的护理。版权所有 © 2024。由 Elsevier Ltd 出版。
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.Copyright © 2024. Published by Elsevier Ltd.