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Published on: February 26, 2013
Risk scores for major bleeding from direct oral anticoagulants: comparing predictive performance in patients with
Alessandra M Campos-Staffico1, Juliet P Jacoby1, Michael P Dorsch1
1Department of Clinical Pharmacy, College of Pharmacy, University of Michigan, Ann Arbor, Michigan, USA.
Insights
The Outcomes Registry for Better Informed Treatment of Atrial Fibrillation (ORBIT-AF) and Anticoagulation and Risk Factors in Atrial Fibrillation (ATRIA) scores best predict major bleeding in patients taking direct oral anticoagulants (DOACs) within 1100 days. No scores showed predictive benefit beyond 2100 days.
Area of Science:
- Cardiology
- Pharmacology
- Clinical Risk Assessment
Background:
- Direct oral anticoagulants (DOACs) are safer for stroke prevention in atrial fibrillation (AF) than warfarin, but major bleeding risks persist.
- Existing bleeding risk scores were developed before DOACs, potentially limiting their accuracy in current patient populations.
Purpose of the Study:
- To compare the performance of the Age, history of Bleeding, and non-bleeding related Hospitalisation (ABH) score with five other established scores in predicting DOAC-related major bleeding in AF patients.
- To evaluate the predictive accuracy of the ABH, ATRIA, HAS-BLED, HEMORR2HAGES, ORBIT-AF, and CHA2DS2-VASc scores for major bleeding events in patients treated with DOACs.
Main Methods:
- Retrospective analysis of 2364 patients with nonvalvular AF on rivaroxaban or apixaban.
- International Society on Thrombosis and Haemostasis (ISTH) criteria were used to define major bleeding.
- Time-dependent receiver operating characteristic (ROC) curve analysis, using C-statistics, was the primary method for comparing score performance.
Main Results:
- At 100 and 1100 days, the ORBIT-AF and ATRIA scores demonstrated the highest C-statistics, indicating superior predictive performance for DOAC-related major bleeding.
- ORBIT-AF showed significantly higher C-statistics than all other scores except ATRIA at 1100 days.
- No significant differences in predictive performance were observed among the scores at 2100 days, with all C-statistics below 0.60.
Conclusions:
- The ORBIT-AF and ATRIA bleeding risk scores offer the most reliable prediction of major bleeding events within the initial 1100 days of DOAC therapy in AF patients.
- The predictive utility of all evaluated bleeding risk scores diminishes significantly beyond 1100 days, suggesting limitations for long-term risk assessment in DOAC users.
Background:
Despite direct oral anticoagulants (DOACs) being safer than warfarin for stroke prevention in atrial fibrillation (AF), major bleeding concerns persist. Most bleeding risk scores predate DOAC approval.
Objectives:
This study aimed to compare the Age, history of Bleeding, and non-bleeding related Hospitalisation [ABH] score's performance-derived for DOAC-treated patients-with those of 5 other scores (Anticoagulation and Risk Factors in Atrial Fibrillation [ATRIA], Hypertension, Abnormal renal/liver function, Stroke, Bleeding history or predisposition, Labile international normalized ratio, Elderly [>65 years], Drugs/alcohol concomitantly [HAS-BLED], Hepatic, Hepatic or Renal Disease, Ethanol Abuse, Malignancy, Older Age, Reduced Platelet Count or Function, Re-Bleeding, Hypertension, Anemia, Genetic Factors, Excessive Fall Risk and Stroke [HEMORR2HAGES], Outcomes Registry for Better Informed Treatment of Atrial Fibrillation [ORBIT-AF], and Congestive heart failure, Hypertension, Age ≥75 [doubled], Diabetes, Stroke [doubled]-Vascular disease, Age 65-74, Sex category [CHA2DS2-VASc]) in predicting DOAC-related major bleeding in patients with AF.
Methods:
In this retrospective study of 2364 patients with nonvalvular AF on rivaroxaban or apixaban (median age, 68.3 years; 32.1% women), International Society on Thrombosis and Haemostasis-defined major bleeding (incidence, 4.1%; n = 97) was analyzed. C-statistics from time-dependent receiver operating characteristic (ROC) curves for continuous risk scores were the primary comparison metric, but other metrics, such as decision curves, were also compared.
Results:
At 100 days, C-statistics were highest for ORBIT-AF and ATRIA (0.62 and 0.61, respectively, with other scores having an area under the ROC curve of <0.60); some significant differences favored ORBIT-AF. At 1100 days, C-statistics remained highest for ORBIT-AF and ATRIA (0.62 and 0.61, respectively, with other scores having an area under the ROC curve of <0.60 again), and ORBIT-AF had significantly higher C-statistics than those for all other risk scores (P < .05), except for ATRIA. At 2100 days, all C-statistics were <0.60 with no significant differences. Decision curves showed the greatest net benefit for ORBIT-AF and ATRIA at 100 days and for ATRIA at 1100 days, with no discernible net benefit for any of the scores at 2100 days.
Conclusion:
ORBIT-AF and ATRIA provided the best bleeding risk prediction within the first 1100 days. None of the 6 bleeding risk scores provided predictive benefit over 2100 days of DOAC treatment.
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