Major Bleeding in Patients with Non-Valvular Atrial Fibrillation: Impact of Time in Therapeutic Range on Contemporary Bleeding Risk Scores
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Key result
High-risk HAS-BLED and ORBIT scores linked to ~62% increased major bleeding risk.
- HR 1.62
- 95% CI 1.06-2.48
- P=0.026
- n=3,551
Why the study?
Does incorporating time in therapeutic range (TTR) improve the predictive performance of ORBIT, ATRIA, and HEMORR2HAGES bleeding risk scores in warfarin-treated patients with non-valvular atrial fibrillation?
Population
3,551 patients with non-valvular atrial fibrillation assigned to the warfarin treatment arm in the pooled…
Comparison
Bleeding risk assessment using modified ORBIT… vs Original bleeding risk scores without TTR…
Design
Cohort
Follow-up
median 1.6 years
Authors
Discussion
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Implication
Supports TTR integration into ORBIT/ATRIA/HEMORR2HAGES for AF on VKA; leaves open whether prediction gains alter decisions.
Key Points
- This research examines how including time in therapeutic range (TTR) affects bleeding risk prediction in patients with atrial fibrillation.
- Analyzed 127 major bleeding events in warfarin-treated patients.
- Compared bleeding risk scores: HAS-BLED, ORBIT, ATRIA, and HEMORR2HAGES with and without TTR.
- Used Cox regression analysis to identify risk associations with major bleeding events.
- 21.3% of major bleeding events occurred in 'low-risk' HAS-BLED category (1.8 per 100 patient-years).
- High-risk categories of HAS-BLED and ORBIT significantly associated with major bleeding events (p = 0.023 and p = 0.022).
- Incorporating TTR significantly improved predictive performance of ORBIT, ATRIA, and HEMORR2HAGES for major bleeding.
Study Design
Type
Observational (n=3,551)
Multicenter
Yes
Structured PICO
Does incorporating time in therapeutic range (TTR) improve the predictive performance of ORBIT, ATRIA, and HEMORR2HAGES bleeding risk scores in warfarin-treated patients with non-valvular atrial fibrillation?
P
Population
3,551 patients with non-valvular atrial fibrillation assigned to the warfarin treatment arm in the pooled SPORTIF III and V trials, median age 72, 69.5% male.
I
Intervention
Bleeding risk assessment using modified ORBIT, ATRIA, and HEMORR2HAGES scores incorporating time in therapeutic range (TTR < 65%).
C
Comparator
Original bleeding risk scores (HAS-BLED, ORBIT, ATRIA, HEMORR2HAGES) without TTR modification.
O
Outcome
Major bleeding events (investigator level and adjudicated events).safety
Main Result
Effect estimate: HR 1.62 (95% CI 1.06-2.48)
p-value: p=0.026
Incorporating time in therapeutic range (TTR) into contemporary bleeding risk scores like ORBIT and ATRIA significantly improves their ability to predict major bleeding in patients with atrial fibrillation on vitamin K antagonists.
Limitations
- Post-hoc, retrospective nature of the analysis
- Relatively short follow-up observation period
- Not all factors required for scores assessment were present in the dataset (e.g., genetic factors for HEMORR2HAGES)
- Used only Cockroft-Gault creatinine clearance calculation for renal function assessment
- Study patients were carefully followed up as per clinical trial protocol, potentially lowering bleeding rates
- Exclusion of some patients at very high bleeding risk due to trial criteria
- post-hoc, retrospective nature of our analysis
- relatively short follow-up observation period
- not all the factors (e.g. genetic factors for HEMORR2HAGES) required for scores assessment were present
- used only the Cockroft-Gault creatinine clearance calculation for renal function assessment
- patients at very high bleeding risk were excluded due to the trial exclusion criteria
Cite This Study
Proietti et al. (2016) conducted an observational in Non-valvular atrial fibrillation (n=3,551). HAS-BLED score (high risk category) vs. Low risk category was evaluated on Adjudicated major bleeding events (HR 1.62, 95% CI 1.06-2.48, p=0.026). HAS-BLED and ORBIT high-risk categories significantly predicted adjudicated major bleeding (HR 1.62 and 1.83), while adding time in therapeutic range improved the predictive performance of other scores.
Topics
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