Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2023 Apr;10(1):e002273.
doi: 10.1136/openhrt-2023-002273.

External validation and updating of prediction models of bleeding risk in patients with cancer receiving anticoagulants

E M Trinks-Roerdink  1 , G J Geersing  2 , Mew Hemels  3   4 , I C van Gelder  5 , F A Klok  6 , M van Smeden  7 , F H Rutten  2 , S van Doorn  2
Affiliations

External validation and updating of prediction models of bleeding risk in patients with cancer receiving anticoagulants

E M Trinks-Roerdink et al. Open Heart. 2023 Apr.

Abstract

Objective: Patients with cancer are at increased bleeding risk, and anticoagulants increase this risk even more. Yet, validated bleeding risk models for prediction of bleeding risk in patients with cancer are lacking. The aim of this study is to predict bleeding risk in anticoagulated patients with cancer.

Methods: We performed a study using the routine healthcare database of the Julius General Practitioners' Network. Five bleeding risk models were selected for external validation. Patients with a new cancer episode during anticoagulant treatment or those initiating anticoagulation during active cancer were included. The outcome was the composite of major bleeding and clinically relevant non-major (CRNM) bleeding. Next, we internally validated an updated bleeding risk model accounting for the competing risk of death.

Results: The validation cohort consisted of 1304 patients with cancer, mean age 74.0±10.9 years, 52.2% males. In total 215 (16.5%) patients developed a first major or CRNM bleeding during a mean follow-up of 1.5 years (incidence rate; 11.0 per 100 person-years (95% CI 9.6 to 12.5)). The c-statistics of all selected bleeding risk models were low, around 0.56. Internal validation of an updated model accounting for death as competing risk showed a slightly improved c-statistic of 0.61 (95% CI 0.54 to 0.70). On updating, only age and a history of bleeding appeared to contribute to the prediction of bleeding risk.

Conclusions: Existing bleeding risk models cannot accurately differentiate bleeding risk between patients. Future studies may use our updated model as a starting point for further development of bleeding risk models in patients with cancer.

Keywords: atrial fibrillation; epidemiology; pharmacology; pharmacology, clinical.

PubMed Disclaimer

Conflict of interest statement

Competing interests: SvD reports an unrestricted institutional grant for performing research in the field of stroke diagnosis from Stoffels-Hornstra. G-JG, FR and MH report unrestricted institutional grants for performing research in the field of atrial fibrillation from Boehringer-Ingelheim, Bayer Healthcare, BMS Pfizer and Daiichi Sankyo. FAK reports research support from Bayer, BMS, BSCI, MSD, Leo Pharma, Actelion, The Netherlands Organisation for Health Research and Development, The Dutch Thrombosis Association, The Dutch Heart Foundation and the Horizon Europe Program. ICVG reports consultancy fees from Boston, BMS and Bayer to the institution, unrestricted research grants from the Netherlands Cardiovascular Research Initiative, unrestricted research grant from the European Union’s Horizon 2020 research and innovation programme under grant agreement; EHRA-PATHS (945260).

Figures

Figure 1
Figure 1
Calibration plot final model.
Figure 2
Figure 2
Relation between estimated bleeding risk, age and history of bleeding.
See this image and copyright information in PMC

Similar articles

See all similar articles

Cited by

References

    1. Khorana AA. Venous thromboembolism and prognosis in cancer. Thromb Res 2010;125:490–3. 10.1016/j.thromres.2009.12.023 - DOI - PMC - PubMed
    1. Kamphuisen PW, Beyer-Westendorf J. Bleeding complications during anticoagulant treatment in patients with cancer. Thromb Res 2014;133 Suppl 2:S49–55. 10.1016/S0049-3848(14)50009-6 - DOI - PubMed
    1. Kaptein FHJ, Stals MAM, Kapteijn MY, et al. . Incidence and determinants of thrombotic and bleeding complications in patients with glioblastoma. J Thromb Haemost 2022;20:1665–73. 10.1111/jth.15739 - DOI - PMC - PubMed
    1. Angelini DE, Radivoyevitch T, McCrae KR, et al. . Bleeding incidence and risk factors among cancer patients treated with anticoagulation. Am J Hematol 2019;94:780–5. 10.1002/ajh.25494 - DOI - PubMed
    1. Prommer E. Management of bleeding in the terminally ill patient. Hematology 2005;10:167–75. 10.1080/10245330500093237 - DOI - PubMed