Philippe Généreux1, Gennaro Giustino2, Bernhard Witzenbichler3, Giora Weisz4, Thomas D Stuckey5, Michael J Rinaldi6, Franz-Josef Neumann7, D Christopher Metzger8, Timothy D Henry9, David A Cox10, Peter L Duffy11, Ernest Mazzaferri12, Mayank Yadav13, Dominic P Francese13, Tullio Palmerini14, Ajay J Kirtane15, Claire Litherland13, Roxana Mehran16, Gregg W Stone17. 1. Cardiovascular Research Foundation, New York, New York; Columbia University Medical Center/NewYork-Presbyterian Hospital, New York, New York; Hôpital du Sacré-Coeur de Montréal, Montréal, Québec, Canada. 2. Icahn School of Medicine at Mount Sinai, New York, New York. 3. Helios Amper-Klinikum, Dachau, Germany. 4. Cardiovascular Research Foundation, New York, New York; Columbia University Medical Center/NewYork-Presbyterian Hospital, New York, New York; Shaare Zedek Medical Center, Jerusalem, Israel. 5. LeBauer Cardiovascular Research Foundation/Cone Health, Greensboro, North Carolina. 6. Sanger Heart & Vascular Institute/Carolinas HealthCare System, Charlotte, North Carolina. 7. Universitäts-Herzzentrum Freiburg Bad Krozingen, Bad Krozingen, Germany. 8. Wellmont CVA Heart Institute, Kingsport, Tennessee. 9. Minneapolis Heart Institute Foundation at Abbott Northwestern Hospital, Minneapolis, Minnesota; Cedars-Sinai Medical Center, Los Angeles, California. 10. Lehigh Valley Health Network, Allentown, Pennsylvania. 11. Reid Heart Center, FirstHealth of the Carolinas, Pinehurst, North Carolina. 12. The Ohio State University Wexner Medical Center, Columbus, Ohio. 13. Cardiovascular Research Foundation, New York, New York. 14. Dipartimento Cardiovascolare, Policlinico S. Orsola, University of Bologna, Bologna, Italy. 15. Cardiovascular Research Foundation, New York, New York; Columbia University Medical Center/NewYork-Presbyterian Hospital, New York, New York. 16. Cardiovascular Research Foundation, New York, New York; Icahn School of Medicine at Mount Sinai, New York, New York. 17. Cardiovascular Research Foundation, New York, New York; Columbia University Medical Center/NewYork-Presbyterian Hospital, New York, New York. Electronic address: gs2184@columbia.edu.
Abstract
BACKGROUND: The incidence, predictors, and prognostic impact of post-discharge bleeding (PDB) after percutaneous coronary intervention (PCI) with drug-eluting stent (DES) implantation are unclear. OBJECTIVES: This study sought to characterize the determinants and consequences of PDB after PCI. METHODS: The prospective ADAPT-DES (Assessment of Dual Antiplatelet Therapy With Drug-Eluting Stents) study was used to determine the incidence and predictors of clinically relevant bleeding events occurring within 2 years after hospital discharge. The effect of PDB on subsequent 2-year all-cause mortality was estimated by time-adjusted Cox proportional hazards regression. RESULTS: Among 8,582 "all-comers" who underwent successful PCI with DES in the ADAPT-DES study, PDB occurred in 535 of 8,577 hospital survivors (6.2%) at a median time of 300 days (interquartile range: 130 to 509 days) post-discharge. Gastrointestinal bleeding (61.7%) was the most frequent source of PDB. Predictors of PDB included older age, lower baseline hemoglobin, lower platelet reactivity on clopidogrel, and use of chronic oral anticoagulation therapy. PDB was associated with higher crude rates of all-cause mortality (13.0% vs. 3.2%; p < 0.0001). Following multivariable adjustment, PDB was strongly associated with 2-year mortality (hazard ratio [HR]: 5.03; p < 0.0001), with an effect size greater than that of post-discharge myocardial infarction (PDMI) (HR: 1.92; p = 0.009). CONCLUSIONS: After successful PCI with DES in an unrestricted patient population, PDB is not uncommon and has a strong relationship with subsequent all-cause mortality, greater that that associated with PDMI. Efforts to reduce PDB may further improve prognosis after successful DES implantation. (Assessment of Dual Antiplatelet Therapy With Drug-Eluting Stents [ADAPT-DES]; NCT00638794).
RCT Entities:
BACKGROUND: The incidence, predictors, and prognostic impact of post-discharge bleeding (PDB) after percutaneous coronary intervention (PCI) with drug-eluting stent (DES) implantation are unclear. OBJECTIVES: This study sought to characterize the determinants and consequences of PDB after PCI. METHODS: The prospective ADAPT-DES (Assessment of Dual Antiplatelet Therapy With Drug-Eluting Stents) study was used to determine the incidence and predictors of clinically relevant bleeding events occurring within 2 years after hospital discharge. The effect of PDB on subsequent 2-year all-cause mortality was estimated by time-adjusted Cox proportional hazards regression. RESULTS: Among 8,582 "all-comers" who underwent successful PCI with DES in the ADAPT-DES study, PDB occurred in 535 of 8,577 hospital survivors (6.2%) at a median time of 300 days (interquartile range: 130 to 509 days) post-discharge. Gastrointestinal bleeding (61.7%) was the most frequent source of PDB. Predictors of PDB included older age, lower baseline hemoglobin, lower platelet reactivity on clopidogrel, and use of chronic oral anticoagulation therapy. PDB was associated with higher crude rates of all-cause mortality (13.0% vs. 3.2%; p < 0.0001). Following multivariable adjustment, PDB was strongly associated with 2-year mortality (hazard ratio [HR]: 5.03; p < 0.0001), with an effect size greater than that of post-discharge myocardial infarction (PDMI) (HR: 1.92; p = 0.009). CONCLUSIONS: After successful PCI with DES in an unrestricted patient population, PDB is not uncommon and has a strong relationship with subsequent all-cause mortality, greater that that associated with PDMI. Efforts to reduce PDB may further improve prognosis after successful DES implantation. (Assessment of Dual Antiplatelet Therapy With Drug-Eluting Stents [ADAPT-DES]; NCT00638794).