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Derivation and Validation of the PRECISE-HBR Score to Predict Bleeding After Percutaneous Coronary Intervention
Felice Gragnano1,2, David van Klaveren3, Dik Heg4
1Department of Translational Medical Sciences, University of Campania Luigi Vanvitelli, Caserta, Italy (F.G., P.C.).
Insights
A new bleeding risk score, PRECISE-HBR, accurately identifies patients at high risk of bleeding after percutaneous coronary intervention. This score improves upon existing methods for personalized treatment strategies.
Area of Science:
- Cardiology
- Interventional Cardiology
- Clinical Risk Stratification
Background:
- Accurate bleeding risk stratification is crucial for personalizing treatment after percutaneous coronary intervention (PCI).
- Existing risk scores have limitations, highlighting the need for more precise and standardized methods for identifying high bleeding risk (HBR) patients.
Purpose of the Study:
- To derive and validate a novel bleeding risk score, PRECISE-HBR, by enhancing the PRECISE-DAPT score with Academic Research Consortium for High Bleeding Risk (ARC-HBR) criteria.
- To improve the identification and management of patients at high risk of bleeding following PCI.
Main Methods:
- The PRECISE-HBR score was developed using a large derivation cohort (29,188 patients) and validated in two independent external cohorts (MASTER DAPT and STOPDAPT-2).
- The score incorporates factors such as age, renal function, hemoglobin, white blood cell count, prior bleeding, oral anticoagulation, and ARC-HBR criteria.
- Statistical analysis included Fine-Gray modeling and multivariable analysis to identify predictors of Bleeding Academic Research Consortium (BARC) 3 or 5 bleeding within one year.
Main Results:
- The PRECISE-HBR score demonstrated good discrimination for 1-year BARC 3 or 5 bleeding, with an Area Under the Curve (AUC) ranging from 0.72 to 0.74 across validation cohorts.
- It showed superior predictive performance compared to the PRECISE-DAPT score.
- A cutoff of 23 points identified a significant proportion of patients (39.1%) at elevated bleeding risk (≥4%).
Conclusions:
- The PRECISE-HBR score is a simple, contemporary 7-item tool for predicting bleeding risk post-PCI.
- It offers a moderate improvement in predictive discrimination over existing risk scores.
- Further research is needed to evaluate its clinical utility and impact on patient management.
Background:
Accurate bleeding risk stratification after percutaneous coronary intervention is important for treatment individualization. However, there is still an unmet need for a more precise and standardized identification of patients at high bleeding risk. We derived and validated a novel bleeding risk score by augmenting the Predicting Bleeding Complications in Patients Undergoing Stent Implantation and Subsequent Dual Antiplatelet Therapy (PRECISE-DAPT) score with the Academic Research Consortium for High Bleeding Risk (ARC-HBR) criteria.
Methods:
The derivation cohort comprised 29 188 patients undergoing percutaneous coronary intervention, of whom 1136 (3.9%) had Bleeding Academic Research Consortium (BARC) 3 or 5 bleeding at 1 year, from 4 contemporary real-world registries and the XIENCE V USA trial. The PRECISE-DAPT score was refitted with a Fine-Gray model in the derivation cohort and extended with the ARC-HBR criteria. The primary outcome was BARC 3 or 5 bleeding within 1 year. Independent predictors of BARC 3 or 5 bleeding were selected at multivariable analysis (P<0.01). The discrimination of the score was internally assessed with apparent validation and cross-validation. The score was externally validated in 4578 patients from the MASTER DAPT trial (Management of High Bleeding Risk Patients Post Bioresorbable Polymer Coated Stent Implantation With an Abbreviated Versus Prolonged DAPT Regimen) and 5970 patients from the STOPDAPT-2 (Short and Optimal Duration of Dual Antiplatelet Therapy-2) total cohort.
Results:
The PRECISE-HBR score (age, estimated glomerular filtration rate, hemoglobin, white blood cell count, previous bleeding, oral anticoagulation, and ARC-HBR criteria) showed an area under the curve (AUC) for 1-year BARC 3 or 5 bleeding of 0.73 (95% CI, 0.71-0.74) at apparent validation, 0.72 (95% CI, 0.70-0.73) at cross-validation, 0.74 (95% CI, 0.68-0.80) in MASTER DAPT, and 0.73 (95% CI, 0.66-0.79) in STOPDAPT-2, with superior discrimination compared with PRECISE-DAPT (cross-validation: ΔAUC, 0.01; P=0.02; MASTER DAPT: ΔAUC, 0.05; P=0.004; STOPDAPT-2: ΔAUC, 0.02; P=0.20) and other risk scores. In the derivation cohort, a cutoff of 23 points identified 11 414 patients (39.1%) with a 1-year BARC 3 or 5 bleeding risk ≥4%. An alternative version of the score, including acute myocardial infarction on admission instead of white blood cell count, showed similar predictive ability.
Conclusions:
The PRECISE-HBR score is a contemporary, simple 7-item risk score to predict bleeding after percutaneous coronary intervention, offering a moderate improvement in discrimination over multiple existing scores. Further evaluation is required to assess its impact on clinical practice.
