title: Computing Methods for Composite Clinical Endpoints in Unprotected Left Main Coronary Artery Revascularization: A Post Hoc Analysis of the DELTA Registry.
abstract: The study sought to investigate the impact of different computing methods for composite endpoints other than time-to-event (TTE) statistics in a large, multicenter registry of unprotected left main coronary artery (ULMCA) disease.
  
  
  
  TTE statistics for composite outcome measures used in ULMCA studies consider only the first event, and all the contributory outcomes are handled as if of equal importance.
  
  
  
  The TTE, Andersen-Gill, win ratio (WR), competing risk, and weighted composite endpoint (WCE) computing methods were applied to ULMCA patients revascularized by percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) at 14 international centers.
  
  
  
  At a median follow-up of 1,295 days (interquartile range: 928 to 1,713 days), all analyses showed no difference in combinations of death, myocardial infarction, and cerebrovascular accident between PCI and CABG. When target vessel revascularization was incorporated in the composite endpoint, the TTE (p = 0.03), Andersen-Gill (p = 0.04), WR (p = 0.025), and competing risk (p < 0.001) computing methods showed CABG to be significantly superior to PCI in the analysis of 1,204 propensity-matched patients, whereas incorporating the clinical relevance of the component endpoints using WCE resulted in marked attenuation of the treatment effect of CABG, with loss of significance for the difference between revascularization strategies (p = 0.10).
  
  
  
  In a large study of ULMCA revascularization, incorporating the clinical relevance of the individual outcomes resulted in sensibly different findings as compared with the conventional TTE approach. In particular, using the WCE computing method, PCI and CABG were no longer significantly different with respect to the composite of death, myocardial infarction, cerebrovascular accident, or target vessel revascularization at a median of 3 years.
authors.affiliation: Cardio-Thoracic-Vascular Department, Ferrarotto Hospital, University of Catania, Catania, Italy. Electronic address: dcapodanno@gmail.com.
authors.forename: Davide
authors.initials: D
authors.lastname: Capodanno
authors.affiliation: Cardio-Thoracic-Vascular Department, Ferrarotto Hospital, University of Catania, Catania, Italy; Department of Advanced Biomedical Sciences, Federico II University of Naples, Naples, Italy.
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Gargiulo
authors.affiliation: Cardio-Thoracic-Vascular Department, Ferrarotto Hospital, University of Catania, Catania, Italy.
authors.forename: Sergio
authors.initials: S
authors.lastname: Buccheri
authors.affiliation: Department of Cardio-Thoracic and Vascular Diseases, San Raffaele Scientific Institute, Milan, Italy.
authors.forename: Alaide
authors.initials: A
authors.lastname: Chieffo
authors.affiliation: Interventional Cardiology Unit, A. O. Ordine Mauriziano Umberto I, Turin, Italy.
authors.forename: Emanuele
authors.initials: E
authors.lastname: Meliga
authors.affiliation: Department of Cardio-Thoracic and Vascular Diseases, San Raffaele Scientific Institute, Milan, Italy.
authors.forename: Azeem
authors.initials: A
authors.lastname: Latib
authors.affiliation: Department of Cardiology, Center for Medical Research and Information, University of Ulsan College of Medicine, Asan Medical Center, Seoul, South Korea.
authors.forename: Seung-Jung
authors.initials: SJ
authors.lastname: Park
authors.affiliation: Thoraxcenter, Erasmus Medical Center, Rotterdam, the Netherlands.
authors.forename: Yoshinobu
authors.initials: Y
authors.lastname: Onuma
authors.affiliation: Cardio-Thoracic-Vascular Department, Ferrarotto Hospital, University of Catania, Catania, Italy.
authors.forename: Piera
authors.initials: P
authors.lastname: Capranzano
authors.affiliation: Bern University Hospital, Bern, Switzerland.
authors.forename: Marco
authors.initials: M
authors.lastname: Valgimigli
authors.affiliation: Latvian Centre of Cardiology, Pauls Stradins Clinical University Hospital, and Institute of Cardiology, University of Latvia, Riga, Latvia.
authors.forename: Inga
authors.initials: I
authors.lastname: Narbute
authors.affiliation: Cedars-Sinai Heart Institute, Cedars-Sinai Medical Center, Los Angeles, California.
authors.forename: Raj R
authors.initials: RR
authors.lastname: Makkar
authors.affiliation: Cardiac Catheterization Laboratory, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts.
authors.forename: Igor F
authors.initials: IF
authors.lastname: Palacios
authors.affiliation: Department of Cardiology, Center for Medical Research and Information, University of Ulsan College of Medicine, Asan Medical Center, Seoul, South Korea.
authors.forename: Young-Hak
authors.initials: YH
authors.lastname: Kim
authors.affiliation: Center for Cardiovascular Research and Development of American Heart of Poland, Katowice, Poland.
authors.forename: Pawel E
authors.initials: PE
authors.lastname: Buszman
authors.affiliation: Cedars-Sinai Heart Institute, Cedars-Sinai Medical Center, Los Angeles, California.
authors.forename: Tarun
authors.initials: T
authors.lastname: Chakravarty
authors.affiliation: Interventional Cardiology, Division of Cardiology, University of Turin, S. Giovanni Battista Molinette Hospital, Turin, Italy.
authors.forename: Imad
authors.initials: I
authors.lastname: Sheiban
authors.affiliation: Mount-Sinai Medical Center, New York, New York.
authors.forename: Roxana
authors.initials: R
authors.lastname: Mehran
authors.affiliation: Klinik für Kardiologie und Angiologie, Elisabeth-Krankenhaus, Essen, Germany.
authors.forename: Christoph
authors.initials: C
authors.lastname: Naber
authors.affiliation: Cedars-Sinai Heart Institute, Cedars-Sinai Medical Center, Los Angeles, California.
authors.forename: Ronan
authors.initials: R
authors.lastname: Margey
authors.affiliation: Cardiac Catheterization Laboratory, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts.
authors.forename: Arvind
authors.initials: A
authors.lastname: Agnihotri
authors.affiliation: Interventional Cardiology, Division of Cardiology, University of Turin, S. Giovanni Battista Molinette Hospital, Turin, Italy.
authors.forename: Sebastiano
authors.initials: S
authors.lastname: Marra
authors.affiliation: Columbia University Medical Center and Cardiovascular Research Foundation, New York, New York.
authors.forename: Martin B
authors.initials: MB
authors.lastname: Leon
authors.affiliation: Columbia University Medical Center and Cardiovascular Research Foundation, New York, New York.
authors.forename: Jeffrey W
authors.initials: JW
authors.lastname: Moses
authors.affiliation: Clinique Pasteur, Toulouse, France.
authors.forename: Jean
authors.initials: J
authors.lastname: Fajadet
authors.affiliation: Hopital privé Jacques Cartier, Ramsay Générale de Santé, Massy, France.
authors.forename: Thierry
authors.initials: T
authors.lastname: Lefèvre
authors.affiliation: Hopital privé Jacques Cartier, Ramsay Générale de Santé, Massy, France.
authors.forename: Marie-Claude
authors.initials: MC
authors.lastname: Morice
authors.affiliation: Latvian Centre of Cardiology, Pauls Stradins Clinical University Hospital, and Institute of Cardiology, University of Latvia, Riga, Latvia.
authors.forename: Andrejs
authors.initials: A
authors.lastname: Erglis
authors.affiliation: Department of Cardio-Thoracic and Vascular Diseases, San Raffaele Scientific Institute, Milan, Italy.
authors.forename: Ottavio
authors.initials: O
authors.lastname: Alfieri
authors.affiliation: Thoraxcenter, Erasmus Medical Center, Rotterdam, the Netherlands.
authors.forename: Patrick W
authors.initials: PW
authors.lastname: Serruys
authors.affiliation: Department of Cardio-Thoracic and Vascular Diseases, San Raffaele Scientific Institute, Milan, Italy.
authors.forename: Antonio
authors.initials: A
authors.lastname: Colombo
authors.affiliation: Cardio-Thoracic-Vascular Department, Ferrarotto Hospital, University of Catania, Catania, Italy.
authors.forename: Corrado
authors.initials: C
authors.lastname: Tamburino
mesh_terms: D000368:Aged; D002561:Cerebrovascular Disorders / Q000209:etiology; D001026:Coronary Artery Bypass / Q000009:adverse effects / Q000401:mortality / Q000706:statistics & numerical data*; D003324:Coronary Artery Disease / Q000175:diagnosis / Q000401:mortality / Q000628:therapy*; D003627:Data Interpretation, Statistical; D054855:Drug-Eluting Stents; D023381:Endpoint Determination / Q000706:statistics & numerical data; D005260:Female; D006801:Humans; D053208:Kaplan-Meier Estimate; D016015:Logistic Models; D008297:Male; D008390:Markov Chains; D008875:Middle Aged; D015233:Models, Statistical; D015999:Multivariate Analysis; D009203:Myocardial Infarction / Q000209:etiology; D062645:Percutaneous Coronary Intervention / Q000009:adverse effects / Q000295:instrumentation / Q000401:mortality / Q000706:statistics & numerical data*; D057216:Propensity Score; D016016:Proportional Hazards Models; D012042:Registries / Q000706:statistics & numerical data*; D012107:Research Design / Q000706:statistics & numerical data*; D018570:Risk Assessment; D012307:Risk Factors; D013997:Time Factors; D016896:Treatment Outcome
keywords: Andersen-Gill; competing risk; left main; weighted composite event(s); win ratio