According to a new study, among patients receiving extended anticoagulation with apixaban for cancer-associated VTE, four predictors of clinically relevant bleeding were identified. Over a median 12.9-month follow-up, anaemia or thrombocytopenia nearly doubled the bleeding risk (93% increase). Older age, male sex, and having pulmonary embolism as the initial indication also increased bleeding risk by 38%–51%. Three of these factors were additionally linked to a higher risk of major bleeding. The study was published in The Lancet Haematology by Prof Isabelle M. and colleagues.
The API-CAT trial was a randomized, double-blind, non-inferiority trial performed at 121 hospitals within 11 countries from October 11, 2018, to September 6, 2023. A total of 1,766 adults with active cancer and previous acute proximal deep-vein thrombosis or pulmonary embolism who had completed at least 6 months of anticoagulation were enrolled. Patients were centrally randomized on a 1:1 basis to receive full-dose apixaban 5 mg twice daily (n = 900) or reduced-dose apixaban 2.5 mg twice daily (n = 866), given for 12 months. Median follow-up duration was 12.9 months (IQR, 11.8-13.2). The participants were 766 men (43.4%) and 1,000 women (56.6%).
Patients were given either full doses or low doses of apixaban. The main result of this secondary analysis included clinically relevant bleedings within 12 months, differentiated between major and clinically relevant bleedings. The main predictor variables were analyzed via competing risk regression. The relationships were expressed as hazard ratios with 95% CIs.
Key Findings
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Anemia and/or thrombocytopenia: HR 1.93 (95% CI, 1.27–2.95)
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Age ≥75 years: HR 1.51 (95% CI, 1.14–2.02)
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Pulmonary embolism as the index event: HR 1.47 (95% CI, 1.03–2.10)
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Male sex: HR 1.38 (95% CI, 1.05–1.82)
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The association between these predictors and bleeding risk was consistent across cancer types, with no significant interaction with apixaban dosing (all p_interaction >0.30).
Four risk factors have been identified as predictors in patients with cancer-associated VTE who received prolonged apixaban therapy. All these risk factors are very useful for making an appropriate treatment plan.
Reference:
Mahé, I., Chapelle, C., Girard, P., Carrier, M., Palomares, L. J., Samama, C.-M., Helfer, H., Gerotziafas, G., Laporte, S., Vicaut, E., Mismetti, P., API-CAT Study Group, & API-CAT Investigators. (2025). Predictors of clinically relevant bleeding during extended anticoagulation for cancer-associated venous thromboembolism (API-CAT): a post-hoc analysis of a randomised, non-inferiority trial. The Lancet. Haematology. https://doi.org/10.1016/S2352-3026(25)00291-1