Estimating Bleeding Risk in Patients with Cancer-Associated Thrombosis: Evaluation of Existing Risk Scores and Development of a New Risk Score
- 20 September 2021
- journal article
- research article
- Published by Georg Thieme Verlag KG in Thrombosis and Haemostasis
- Vol. 122 (05), 818-829
- https://doi.org/10.1055/s-0041-1735251
Abstract
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. All authors contributed to study conception and design. M.A. de Winter analyzed the data and drafted the manuscript in close collaboration with J.A.N. Dorresteijn and M. Nijkeuter. All authors critically revised the manuscript, were responsible for and approved its final version. Received: 08 April 2021 Accepted: 23 July 2021 Article published online: 20 September 2021 © 2021. Thieme. All rights reserved. Georg Thieme Verlag KG Rüdigerstraße 14, 70469 Stuttgart, GermanyFunding Information
- Daiichi Sankyo, Inc.
This publication has 50 references indexed in Scilit:
- Poor predictive value of contemporary bleeding risk scores during long-term treatment of venous thromboembolismThrombosis and Haemostasis, 2014
- New Oral Anticoagulants and the Cancer PatientThe Oncologist, 2013
- The predictive ability of bleeding risk stratification models in very old patients on vitamin K antagonist treatment for venous thromboembolism: results of the prospective collaborative EPICA studyJournal of Thrombosis and Haemostasis, 2013
- Management of venous thromboembolism (VTE) in cancer patients: ESMO Clinical Practice GuidelinesAnnals of Oncology, 2011
- A Novel User-Friendly Score (HAS-BLED) To Assess 1-Year Risk of Major Bleeding in Patients With Atrial FibrillationSocial psychiatry. Sozialpsychiatrie. Psychiatrie sociale, 2010
- Predictive variables for major bleeding events in patients presenting with documented acute venous thromboembolism. Findings from the RIETE RegistryThrombosis and Haemostasis, 2008
- Predicting recurrences or major bleeding in cancer patients with venous thromboembolismThrombosis and Haemostasis, 2008
- Definition of major bleeding in clinical investigations of antihemostatic medicinal products in non‐surgical patientsJournal of Thrombosis and Haemostasis, 2005
- Recurrent venous thromboembolism and bleeding complications during anticoagulant treatment in patients with cancer and venous thrombosisBlood, 2002
- The Impact of Long-term Warfarin Therapy on Quality of LifeArchives of Internal Medicine, 1991