Division of Population Sciences, Dana-Farber Cancer Institute, Boston, MA, USA.
Department of Biostatistics, Epidemiology, and Informatics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.
Thromb Res. 2024 Dec;244:109184. doi: 10.1016/j.thromres.2024.109184. Epub 2024 Oct 13.
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.
癌症患者发生静脉血栓栓塞症（VTE）的风险增加，但与未患癌症的抗凝治疗患者相比，癌症患者发生复发性 VTE 和出血的风险也增加。CANVAS 是一项随机实用效果试验，比较了直接口服抗凝剂 a 类与低分子肝素治疗癌症患者新发 VTE。CANVAS 试验的这一预先指定的二次分析旨在确定癌症和新发 VTE 患者复发性 VTE 和大出血的预测因素。
分析人群中的 671 名参与者的数据用于确定 6 个月治疗期间复发性 VTE 和出血的预测因素。单变量模型中确定的显著预测因素在多变量模型中向前推进，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 表现状态≥2（HR，3.19 [95%CI，1.45-7.02]；P<0.005）、转移性疾病存在（HR，2.57 [95%CI，1.14-5.80]；P=0.023）、贝伐单抗治疗（HR，2.50 [95%CI，1.04-5.99]；P=0.041）和深静脉血栓形成无肺栓塞作为指数 VTE（HR，1.86 [95%CI，1.04-3.33]；P=0.037）。大出血的独立预测因素包括血清白蛋白<3.5g/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=0.034）。
CANVAS 试验的这项预先指定的分析确定了癌症和新发 VTE 患者复发性 VTE 和大出血的风险因素，反映了当前肿瘤学的临床实践。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，以改善这些患者的护理。
