de Winter Maria A, Dorresteijn Jannick A N, Ageno Walter, Ay Cihan, Beyer-Westendorf Jan, Coppens Michiel, Klok Frederikus A, Moustafa Farès, Riva Nicoletta, Ruiz Artacho Pedro C, Vanassche Thomas, Nijkeuter Mathilde
Department of Acute Internal Medicine, University Medical Center Utrecht, Utrecht, The Netherlands.
Department of Vascular Medicine, University Medical Center Utrecht, Utrecht, The Netherlands.
Thromb Haemost. 2022 May;122(5):818-829. doi: 10.1055/s-0041-1735251. Epub 2021 Sep 20.
Bleeding risk is highly relevant for treatment decisions in cancer-associated thrombosis (CAT). Several risk scores exist, but have never been validated in patients with CAT and are not recommended for practice.
To compare methods of estimating clinically relevant (major and clinically relevant nonmajor) bleeding risk in patients with CAT: (1) existing risk scores for bleeding in venous thromboembolism, (2) pragmatic classification based on cancer type, and (3) new prediction model.
In a posthoc analysis of the Hokusai VTE Cancer study, a randomized trial comparing edoxaban with dalteparin for treatment of CAT, seven bleeding risk scores were externally validated (ACCP-VTE, HAS-BLED, Hokusai, Kuijer, Martinez, RIETE, and VTE-BLEED). The predictive performance of these scores was compared with a pragmatic classification based on cancer type (gastrointestinal; genitourinary; other) and a newly derived competing risk-adjusted prediction model based on clinical predictors for clinically relevant bleeding within 6 months after CAT diagnosis with nonbleeding-related mortality as the competing event ("CAT-BLEED").
Data of 1,046 patients (149 events) were analyzed. Predictive performance of existing risk scores was poor to moderate (C-statistics: 0.50-0.57; poor calibration). Internal validation of the pragmatic classification and "CAT-BLEED" showed moderate performance (respective C-statistics: 0.61; 95% confidence interval [CI]: 0.56-0.66, and 0.63; 95% CI 0.58-0.68; good calibration).
Existing risk scores for bleeding perform poorly after CAT. Pragmatic classification based on cancer type provides marginally better estimates of clinically relevant bleeding risk. Further improvement may be achieved with "CAT-BLEED," but this requires external validation in practice-based settings and with other DOACs and its clinical usefulness is yet to be demonstrated.
出血风险与癌症相关血栓形成（CAT）的治疗决策高度相关。现有几种风险评分，但从未在CAT患者中得到验证，也不推荐用于临床实践。
比较评估CAT患者临床相关（主要和临床相关非主要）出血风险的方法：（1）静脉血栓栓塞症出血的现有风险评分；（2）基于癌症类型的实用分类；（3）新的预测模型。
在一项关于比较依度沙班与达肝素治疗CAT的随机试验——“北里VTE癌症研究”的事后分析中，对7种出血风险评分进行了外部验证（ACCP-VTE、HAS-BLED、北里、库伊杰、马丁内斯、RIETE和VTE-BLEED）。将这些评分的预测性能与基于癌症类型（胃肠道；泌尿生殖系统；其他）的实用分类以及基于临床预测指标新推导的竞争风险调整预测模型进行比较，该模型用于预测CAT诊断后6个月内与非出血相关死亡作为竞争事件的临床相关出血情况（“CAT-BLEED”）。
分析了1046例患者（149例事件）的数据。现有风险评分的预测性能较差至中等（C统计量：0.50 - 0.57；校准不佳）。实用分类和“CAT-BLEED”的内部验证显示性能中等（各自的C统计量：0.61；95%置信区间[CI]：0.56 - 0.66，以及0.63；95% CI 0.58 - 0.68；校准良好）。
CAT后现有出血风险评分表现不佳。基于癌症类型的实用分类对临床相关出血风险的估计略好。“CAT-BLEED”可能会进一步改善，但这需要在基于实践的环境中使用其他直接口服抗凝剂进行外部验证，其临床实用性尚待证明。
