Derivation and Validation of the PRECISE-HBR Score to Predict Bleeding After Percutaneous Coronary Intervention
Abstract
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.
Article Details
Authors (30)
Felice Gragnano
Department of Translational Medical Sciences, University of Campania Luigi Vanvitelli, Caserta, Italy (F.G., P.C.).
David van Klaveren
Dik Heg
Lorenz Räber
Mitchell W. Krucoff
Duke University Medical Center/Duke Clinical Research Institute, Durham, NC (M.W.K.).
Sergio Raposeiras-Roubín
Centro Nacional de Investigaciones Cardiovasculares Carlos III, Madrid
Jurriën M. ten Berg
From the Department of Cardiology, St. Antonius Hospital, Nieuwegein (D.J.G., W.L.B., J.P., B.J.W.M.R., L.T., M.J.S., J.B., V.J.N., D.C.O., J.M.B.), the Department of Cardiology, Amsterdam UMC, Amsterdam (H.M.A., J.G.P.T., R.D.), the Department of Cardiology, University Medical Center Utrecht, Utrecht (H.M.A., M. Voskuil), the Department of Cardiology, Radboud University Medical Center, Nijmegen (M.J.P.R., V.J.N., N.R.), the Department of Cardiology, Maastricht University Medical Center (L.V., A.J.J.I., P.A.V., A.W.J.H.), and Cardiovascular Research Institute Maastricht (L.V., P.A.V., A.W.J.H., J.M.B.), Maastricht, the Department of Cardiology, Leiden University Medical Center, Leiden (F.K., J.M.M.-C.), the Department of Cardiology, University Medical Center Groningen, Groningen (K.H.B., J.J.W.), the Department of Cardiology, Erasmus University Medical Center, Rotterdam (N.M.V.M.), the Department of Cardiology, Haga Hospital, the Hague (C.E.S.), the Department of Cardiology, Amphia Hospital, Breda (A.J.J.I...
Sergio Leonardi
University of Pavia and Fondazione IRCCS Policlinico San Matteo, Italy (S.L.).
Takeshi Kimura
Noé Corpataux
Alessandro Spirito
Department of Cardiology, Bern University Hospital (L.R., N.C., A.S., S.B., R.K., S.W., M.V.), University of Bern, Switzerland.
James B. Hermiller
Department of Cardiology, Ascension St. Vincent’s Heart Center of Indiana, Indianapolis (J.B.H.).
Emad Abu-Assi
Cardiology Department, University Hospital of Povisa, Ribera Salud Group, Vigo, Spain
Dean Chan Pin Yin
Department of Cardiology, St. Antonius Hospital, Nieuwegein, the Netherlands (J.M.t.B., D.C.P.Y., J.A.).
Jaouad Azzahhafi
Department of Cardiology, St. Antonius Hospital, Nieuwegein, the Netherlands (J.M.t.B., D.C.P.Y., J.A.).
Claudio Montalto
Interventional Cardiology, De Gasperis Cardio Center, Niguarda Hospital, Milan, Italy (C.M.).
Marco Galazzi
Department of Molecular Medicine, University of Pavia, Fondazione IRCCS Policlinico San Matteo, Italy (S.L., M.G.).
Sarah Bär
Department of Cardiology, Bern University Hospital (L.R., N.C., A.S., S.B., R.K., S.W., M.V.), University of Bern, Switzerland.
Raminta Kavaliauskaite
Department of Cardiology, Bern University Hospital (L.R., N.C., A.S., S.B., R.K., S.W., M.V.), University of Bern, Switzerland.
Fabrizio D’Ascenzo
Gaetano M. De Ferrari
Cardiology Division, Department of Medical Sciences, University of Turin and Azienda Ospedaliero–Universitaria Città della Salute e della Scienza, Turin, Italy
Hirotoshi Watanabe
Department of Cardiovascular Medicine, Graduate School of Medicine, Kyoto University, Japan (T.K., H.W.).
Philippe Gabriel Steg
French Alliance for Cardiovascular Trials, Paris
Deepak L. Bhatt
Mount Sinai Fuster Heart Hospital, Icahn School of Medicine at Mount Sinai, New York
Paolo Calabrò
Roxana Mehran
Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, NY (R.M.).
Philip Urban
Cardiovascular Department, Hôpital de la Tour, Geneva, Switzerland (P.U.).
Stuart Pocock
Centro Nacional de Investigaciones Cardiovasculares Carlos III, Madrid
Stephan Windecker
Marco Valgimigli
Cardiocentro Ticino Institute, Ente Ospedaliero Cantonale, Università della Svizzera Italiana, Lugano, Switzerland