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.
Bibliographical noteFunding Information:
This study was funded by Bristol-Myers Squibb and Sanofi. Dr. Mehran has received institutional grant support from The Medicines Company, Bristol-Myers Squibb/Sanofi, and Eli Lilly & Company/Daiichi-Sankyo; and is a consultant to Janssen Pharmaceuticals and Maya Medical. Dr. Dangas has received consulting fees and honoraria from Johnson & Johnson, Sanofi, Covidien, The Medicines Company, Merck, CSL Behring, AstraZeneca, Medtronic, Abbott, Bayer, Boston Scientific, Osprey Medical, and GE Healthcare; and research grant support from Sanofi, Bristol-Myers Squibb, and Eli Lilly & Company/Daiichi-Sankyo. Dr. Steg has served as an adviser or a consultant for Amarin Corporation, AstraZeneca Pharmaceuticals LP, Bayer HealthCare Pharmaceuticals, Boehringer Ingelheim Pharmaceuticals, Bristol-Myers Squibb, Daiichi-Sankyo, GlaxoSmithKline, Eli Lilly & Company, Medtronic, Otsuka Pharmaceutical, Pfizer, Roche, Sanofi, Servier, Takeda Pharmaceuticals North America, The Medicines Company, and Vivus; and received clinical research grants from Sanofi and Servier. Dr. Cohen has received research grant support from Abbott Vascular, AstraZeneca, Biomet, Boston Scientific, Cardiovascular Systems, Daiichi-Sankyo, Edwards Lifesciences, Eli Lilly & Company, and Medtronic; and is a consultant for Abbott Vascular, Medtronic, and Merck. Dr. Kini serves on the speakers bureau of the American College of Cardiology; and has received consulting fees from WebMD. Dr. Colombo has received consulting fees and honoraria from CID; and other financial benefit from Direct Flow Medical. Dr. Gibson has received research grant support from Angel Medical Corporation, Atrium Medical Systems, Bayer Corporation, Ikaria, Janssen/Johnson & Johnson Corporation, Lantheus Medical Imaging, Merck & Company, Portola Pharmaceuticals, Roche Diagnostics, Sanofi, Stealth Peptides, St. Jude Medical, Volcano Corporation, and Walk Vascular; consulting fees from AstraZeneca, Baxter Healthcare, Bayer Corporation, CRF, Consensus Medical Communications, CSL Behring, Cytori Therapeutics, Eli Lilly & Company/Daiichi-Sankyo, Exeter Group, Genentech, GlaxoSmithKline, Janssen/Johnson & Johnson Corporation, Ortho McNeil, St. Jude Medical, and The Medicines Company; and royalty fees from UpToDate in Cardiovascular Medicine. Dr. Henry has received research grant support from Eli Lilly & Company and Daiichi-Sankyo. Dr. Krucoff has received consulting fees from Abbott Vascular, Abbott, OrbusNeich, Angelmed, Volcano, Biosensors, Svelte, OrbusNeich, Medtronic, and Terumo; and research grant support from Abbott, Terumo, Angelmed, Ikaria, OrbusNeich, Medtronic, CSI, Eli Lilly & Company, and Medtronic. Dr. Kirtane has received institutional research grants to Columbia University from Boston Scientific, Medtronic, Abbott Vascular, Abiomed, St. Jude Medical, Vascular Dynamics, and Eli Lilly & Company. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose. Dr. Deepak Bhatt served as Guest Editor for this paper.
© 2016 American College of Cardiology Foundation.