Estimating Bleeding Risk in Patients with Cancer-Associated Thrombosis: Evaluation of Existing Risk Scores and Development of a New Risk Score

Maria A. De Winter, Jannick A.N. Dorresteijn, Walter Ageno, Cihan Ay, Jan Beyer-Westendorf, Michiel Coppens, Frederikus A. Klok, Farès Moustafa, Nicoletta Riva, Pedro C. Ruiz Artacho, Thomas Vanassche, Mathilde Nijkeuter*

*Corresponding author for this work

Research output: Contribution to journalArticleAcademicpeer-review


Background 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. Objectives 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. Methods 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"). Results 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). Conclusion 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.

Original languageEnglish
Pages (from-to)818-829
Number of pages12
JournalThrombosis and Haemostasis
Issue number5
Early online date20 Sept 2021
Publication statusPublished - May 2022


  • anticoagulants
  • bleeding
  • cancer
  • venous thromboembolism


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