title: Balancing Long-Term Risks of Ischemic and Bleeding Complications After Percutaneous Coronary Intervention With Drug-Eluting Stents.
abstract: Although trials comparing antiplatelet strategies after percutaneous coronary intervention report average risks of bleeding and ischemia in a population, there is limited information to guide choices based on individual patient risks, particularly beyond 1 year after treatment. Patient-level data from Patient Related Outcomes With Endeavor vs Cypher Stenting Trial (PROTECT), a broadly inclusive trial enrolling 8,709 subjects treated with drug-eluting stents (sirolimus vs zotarolimus-eluting stent), and PROTECT US, a single-arm study including 1,018 subjects treated with a zotarolimus-eluting stent, were combined. The risk of ischemic events, cardiovascular death/non-periprocedural myocardial infarction (MI)/definite or probable stent thrombosis, and bleeding events, Global Use of Strategies to Open Occluded Arteries moderate or severe bleed, were predicted using logistic regression. At median follow-up of 4.1 years, major bleeding occurred in 260 subjects (2.8%) and ischemic events in 595 (6.3%). Multivariate predictors of bleeding were older age, smoking, diabetes mellitus, congestive heart failure, and chronic kidney disease (all p <0.05). Ischemic events shared all the same predictors with bleeding events and gender, body mass index, previous MI, previous coronary artery bypass graft surgery, ST-segment elevation MI on presentation, stent length, and sirolimus-eluting stent use (all p <0.05). Within individual subjects, bleeding and ischemic risks were strongly correlated; 97% of subjects had a greater risk of ischemic events than bleeding. In conclusion, individual patient risks of ischemia and bleeding are related to many common risk factors, yet the predicted risks of ischemic events are greater than those of major bleeding in the large majority of patients in long-term follow-up.
authors.affiliation: Division of Cardiovascular Medicine, Department of Medicine, Brigham and Women's Hospital, Boston, Massachusetts.
authors.forename: Alexis
authors.initials: A
authors.lastname: Matteau
authors.affiliation: Cardiology Division, Department of Medicine, Massachusetts General Hospital, Boston, Massachusetts.
authors.forename: Robert W
authors.initials: RW
authors.lastname: Yeh
authors.affiliation: Cardiology Department, University of Geneva, Geneva, Switzerland.
authors.forename: Edoardo
authors.initials: E
authors.lastname: Camenzind
authors.affiliation: Cardiology Department, DHU-FIRE, Hôpital Bichat, Paris, France; Université Paris-Diderot, Paris, France; INSERM U1148, Paris, France.
authors.forename: P Gabriel
authors.initials: PG
authors.lastname: Steg
authors.affiliation: Cardiology Department, Cardiovascular Research Center Aalst, OLV Hospital, Aalst, Belgium.
authors.forename: William
authors.initials: W
authors.lastname: Wijns
authors.affiliation: Cardiology Department, Cardiothoracic Centre, Liverpool, United Kingdom.
authors.forename: Joseph
authors.initials: J
authors.lastname: Mills
authors.affiliation: Department of Cardiovascular Sciences, University of Leicester, Leicester, United Kingdom; NIHR Leicester Cardiovascular Biomedical Research Unit, University Hospitals of Leicester Glenfield Hospital, Leicester, United Kingdom.
authors.forename: Anthony
authors.initials: A
authors.lastname: Gershlick
authors.affiliation: Cardiology Department, The James Cook University Hospital, Middlesbrough, United Kingdom.
authors.forename: Mark
authors.initials: M
authors.lastname: de Belder
authors.affiliation: Cardiology Department, DHU-FIRE, Hôpital Bichat, Paris, France; Université Paris-Diderot, Paris, France; INSERM U1148, Paris, France.
authors.forename: Gregory
authors.initials: G
authors.lastname: Ducrocq
authors.affiliation: Division of Cardiovascular Medicine, Department of Medicine, Brigham and Women's Hospital, Boston, Massachusetts. Electronic address: lmauri1@partners.org.
authors.forename: Laura
authors.initials: L
authors.lastname: Mauri
mesh_terms: D000368:Aged; D001803:Blood Transfusion / Q000379:methods*; D003324:Coronary Artery Disease / Q000601:surgery*; D004305:Dose-Response Relationship, Drug; D054855:Drug-Eluting Stents / Q000009:adverse effects*; D005060:Europe / Q000453:epidemiology; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007166:Immunosuppressive Agents / Q000494:pharmacology; D015994:Incidence; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000453:epidemiology / Q000209:etiology / Q000517:prevention & control*; D062645:Percutaneous Coronary Intervention / Q000009:adverse effects*; D010975:Platelet Aggregation Inhibitors / Q000008:administration & dosage / Q000627:therapeutic use*; D019106:Postoperative Hemorrhage / Q000453:epidemiology / Q000209:etiology / Q000517:prevention & control*; D011379:Prognosis; D012189:Retrospective Studies; D020123:Sirolimus / Q000031:analogs & derivatives / Q000494:pharmacology; D015996:Survival Rate / Q000639:trends; D013997:Time Factors
chemical_list: D007166:Immunosuppressive Agents; D010975:Platelet Aggregation Inhibitors; C489443:zotarolimus; D020123:Sirolimus