Usman Baber1, Roxana Mehran2, Gennaro Giustino1, David J Cohen3, Timothy D Henry4, Samantha Sartori1, Cono Ariti5, Claire Litherland6, George Dangas1, C Michael Gibson7, Mitchell W Krucoff8, David J Moliterno9, Ajay J Kirtane10, Gregg W Stone10, Antonio Colombo11, Alaide Chieffo11, Annapoorna S Kini1, Bernhard Witzenbichler12, Giora Weisz13, Philippe Gabriel Steg14, Stuart Pocock5. 1. Mount Sinai Heart, Mount Sinai Medical Center, New York, New York. 2. Mount Sinai Heart, Mount Sinai Medical Center, New York, New York. Electronic address: roxana.mehran@mountsinai.org. 3. St. Luke's Mid America Heart Institute, University of Missouri-Kansas City, Kansas City, Missouri. 4. Minneapolis Heart Institute Foundation, University of Minnesota, Minneapolis, Minnesota. 5. London School of Hygiene and Tropical Medicine, London, United Kingdom. 6. Cardiovascular Research Foundation, New York, New York. 7. Division of Cardiology, Beth Israel Deaconess Medical Center, Boston, Massachusetts. 8. Duke University School of Medicine, Durham, North Carolina. 9. University of Kentucky, Lexington, Kentucky. 10. Cardiovascular Research Foundation, New York, New York; Department of Cardiology, Columbia University Medical Center, New York, New York. 11. Cardio-Thoracic Department, San Raffaele Scientific Institute, Milan, Italy. 12. Helios Amper-Klinikum, Dachau, Germany. 13. Shaare Zedek Medical Center, Jerusalem, Israel. 14. Université Paris-Diderot, Sorbonne Paris-Cité, Paris, France.
Abstract
BACKGROUND: Dual-antiplatelet therapy with aspirin and clopidogrel after percutaneous coronary intervention reduces the risk for coronary thrombotic events (CTEs) at the expense of increasing risk for major bleeding (MB). Metrics to accurately predict the occurrence of each respective event and inform clinical decision making are lacking. OBJECTIVES: The aim of this study was to develop and validate separate models to predict risks for out-of-hospital thrombotic and bleeding events after percutaneous coronary intervention with drug-eluting stents. METHODS: Using data from 4,190 patients treated with drug-eluting stents and enrolled in the PARIS (Patterns of Non-Adherence to Anti-Platelet Regimen in Stented Patients) registry, separate risk scores were developed to predict CTE (defined as the composite of stent thrombosis or myocardial infarction) and MB (defined as the occurrence of a Bleeding Academic Research Consortium type 3 or 5 bleed). External validation was performed in the ADAPT-DES (Assessment of Dual Antiplatelet Therapy With Drug-Eluting Stents) registry. RESULTS: Over 2 years, CTEs occurred in 151 patients (3.8%) and MB in 133 (3.3%). Independent predictors of CTEs included acute coronary syndrome, prior revascularization, diabetes mellitus, renal dysfunction, and current smoking. Independent predictors of MB included older age, body mass index, triple therapy at discharge, anemia, current smoking, and renal dysfunction. Each model displayed moderate levels of discrimination and adequate calibration. CONCLUSIONS: Simple risk scores of baseline clinical variables may be useful to predict risks for ischemic and bleeding events after PCI with DES, thereby facilitating clinical decisions surrounding the optimal duration of DAPT. (Patterns of Non-Adherence to Anti-Platelet Regimen in Stented Patients [PARIS]; NCT00998127).
BACKGROUND: Dual-antiplatelet therapy with aspirin and clopidogrel after percutaneous coronary intervention reduces the risk for coronary thrombotic events (CTEs) at the expense of increasing risk for major bleeding (MB). Metrics to accurately predict the occurrence of each respective event and inform clinical decision making are lacking. OBJECTIVES: The aim of this study was to develop and validate separate models to predict risks for out-of-hospital thrombotic and bleeding events after percutaneous coronary intervention with drug-eluting stents. METHODS: Using data from 4,190 patients treated with drug-eluting stents and enrolled in the PARIS (Patterns of Non-Adherence to Anti-Platelet Regimen in Stented Patients) registry, separate risk scores were developed to predict CTE (defined as the composite of stent thrombosis or myocardial infarction) and MB (defined as the occurrence of a Bleeding Academic Research Consortium type 3 or 5 bleed). External validation was performed in the ADAPT-DES (Assessment of Dual Antiplatelet Therapy With Drug-Eluting Stents) registry. RESULTS: Over 2 years, CTEs occurred in 151 patients (3.8%) and MB in 133 (3.3%). Independent predictors of CTEs included acute coronary syndrome, prior revascularization, diabetes mellitus, renal dysfunction, and current smoking. Independent predictors of MB included older age, body mass index, triple therapy at discharge, anemia, current smoking, and renal dysfunction. Each model displayed moderate levels of discrimination and adequate calibration. CONCLUSIONS: Simple risk scores of baseline clinical variables may be useful to predict risks for ischemic and bleeding events after PCI with DES, thereby facilitating clinical decisions surrounding the optimal duration of DAPT. (Patterns of Non-Adherence to Anti-Platelet Regimen in Stented Patients [PARIS]; NCT00998127).
Authors: Gennaro Giustino; Rafael Harari; Usman Baber; Samantha Sartori; Gregg W Stone; Martin B Leon; Stephan Windecker; Patrick W Serruys; Adnan Kastrati; Clemens Von Birgelen; Takeshi Kimura; Giulio G Stefanini; George D Dangas; William Wijns; P Gabriel Steg; Marie-Claude Morice; Edoardo Camenzind; Giora Weisz; Pieter C Smits; Sabato Sorrentino; Madhav Sharma; Serdar Farhan; Michela Faggioni; David Kandzari; Soren Galatius; Raban V Jeger; Marco Valgimigli; Dipti Itchhaporia; Laxmi Mehta; Hyo-Soo Kim; Alaide Chieffo; Roxana Mehran Journal: JAMA Cardiol Date: 2017-08-01 Impact factor: 14.676