Arrhythmias & electrophysiology
Development and Validation of the DOAC Score: A Novel Bleeding Risk Prediction Tool for Patients With Atrial Fibrillation on Direct-Acting Oral Anticoagulants
Authors' conclusion
In individuals with atrial fibrillation potentially eligible for DOAC therapy, the DOAC Score can help stratify patients on the basis of expected bleeding risk.
Study context
- Population
- Patients with atrial fibrillation (AF) taking DOACs (derivation: dabigatran 150 mg twice daily in RE-LY)RE-LY derivation cohort
- Participants
- 5,684 patients
- Comparison
- DOAC Score vs HAS-BLED score
- Outcome
- Major bleeding
Methodological detailssecondary analysis of the RE-LY randomised trial, internal validation with bootstrapping, external validation in COMBINE-AF and RAMQ, 44 countries, 951 centres
- Secondary analysis of the RE-LY randomised trial
- Internal validation with bootstrapping
- External validation in COMBINE-AF and RAMQ
- 44 countries, 951 centres
Performance
As reported in the abstract
Major bleeding prediction (C statistic)
- RE-LY
- C statistic 0.73 versus 0.60; P for difference < 0.001
- GARFIELD-AF, n = 12 296
- C statistic 0.71 versus 0.66; P for difference = 0.025
- COMBINE-AF validation, n = 25 586
- C statistic 0.67 versus 0.63; P for difference < 0.001
- RAMQ validation, n = 11 945
- C statistic 0.65 versus 0.58; P for difference < 0.001
- Optimism-corrected C statistic after bootstrapping (RE-LY)
- 0.73
- Well calibrated (goodness-of-fit)
- P = 0.57
- Increase in major bleeding per additional point (RE-LY)
- 48.7% (95% CI, 38.9%-59.3%; P<0.001)
Further findings
Major bleeding incidence (RE-LY) · median follow-up 1.74 years
- Patients with a major bleeding event
- 386 (6.8%)
Original publication
Development and Validation of the DOAC Score: A Novel Bleeding Risk Prediction Tool for Patients With Atrial Fibrillation on Direct-Acting Oral Anticoagulants. Circulation. Published 25 August 2023. doi:10.
Summarised from the published abstract; every number is checked against it