ONCO-DOAC BLEED Score: New Risk Stratification Tool for Bleeding Risk in Cancer-Associated VTE Patients on DOACs
Key Insights
The novel ONCO-DOAC BLEED risk score was developed to predict major bleeding risk in cancer-associated VTE patients receiving direct oral anticoagulants (search), using data from 1,166 patients in the COMMAND VTE Registry-2 in Japan.
The score incorporates cancer-specific factors including distant metastatic cancer, terminal cancer, and specific cancer types alongside comorbidities and NSAID use, stratifying patients into low (0), intermediate (1), and high (≥2) risk categories.
In the derivation cohort, 127 patients (11%) experienced major bleeding at a median follow-up of 163 days, with the score demonstrating moderate discrimination (Harrell's C-index 0.68).
A newly developed risk stratification tool—the ONCO-DOAC BLEED score (search)—offers clinicians a practical method for identifying major bleeding risk in patients with cancer-associated venous thromboembolism (search) (VTE) who are receiving direct oral anticoagulants (search) (DOACs), according to research published June 16 in JACC: CardioOncology.
The score, developed by Tomoyuki Nagai, MD, and colleagues, was derived using data from 1,166 patients (mean age, 67.9 years; 57% women) enrolled in the prospective COMMAND VTE Registry-2 in Japan, and subsequently validated in a cohort of 779 patients from the ONCO DVT and ONCO PE studies.
Score Composition and Risk Stratification
The ONCO-DOAC BLEED score (search) integrates a range of clinical variables, including history of major bleeding, chronic kidney disease, nonsteroidal anti-inflammatory drug (NSAID) use, distant metastatic cancer, terminal cancer, upper gastrointestinal cancer, pancreatic cancer, and uterine cancer. Each factor is assigned points, with total scores stratifying patients into three risk categories: low (0 points), intermediate (1 point), and high (≥2 points).
“The ONCO-DOAC BLEED score (search) integrates cancer-related characteristics, such as cancer type and disease status (including metastatic and terminal cancers), together with patient comorbidities and concomitant medications,” the authors write, noting that this approach is intended to balance simplicity with clinical relevance.
Clinical Outcomes and Discrimination
At a median follow-up of 163 days, 127 patients (11%) in the COMMAND VTE Registry-2 derivation cohort and 53 patients (7%) in the ONCO DVT and ONCO PE validation cohort experienced major bleeding, defined by the International Society on Thrombosis and Haemostasis criteria.
The score demonstrated moderate discrimination in both cohorts, with a Harrell's C-index of 0.68 and Uno's C-index of 0.67 in the derivation cohort, and a Harrell's C-index of 0.62 and Uno's C-index of 0.63 in the validation cohort.
Comparison With Existing Risk Scores
When benchmarked against established bleeding risk assessment tools, the ONCO-DOAC BLEED score (search) showed higher discrimination in the derivation cohort and comparable discrimination in the validation cohort compared with the VTE-BLEED, RIETE, CAT-BLEED, and Perform scores.
Clinical Implications
The authors emphasize that identifying high-risk patients through this scoring system may facilitate several clinical actions. “Identifying high-risk patients may prompt closer clinical follow-up, careful review of concomitant medications, particularly the use of NSAIDs, and monitoring of changes in patient condition, thereby supporting uninterrupted cancer treatment and optimal VTE management,” they write.
The development of this tool comes amid broader recognition that DOACs, despite robust evidence supporting their efficacy and safety, continue to be underused and at times inappropriately dosed, particularly in patients at elevated thrombotic risk. A recent ACC Scientific Statement published in JACC highlights the need for evidence-based guidance on DOAC use, including bleeding risk assessment, drug selection, dosing strategies, and management of special patient populations such as those with cancer-associated thrombus, chronic kidney disease, liver disease, frailty, obesity, or prior bleeding.