TY - JOUR
T1 - Computing Methods for Composite Clinical Endpoints in Unprotected Left Main Coronary Artery Revascularization
T2 - A Post Hoc Analysis of the DELTA Registry
AU - Capodanno, Davide
AU - Gargiulo, Giuseppe
AU - Buccheri, Sergio
AU - Chieffo, Alaide
AU - Meliga, Emanuele
AU - Latib, Azeem
AU - Park, Seung Jung
AU - Onuma, Yoshinobu
AU - Capranzano, Piera
AU - Valgimigli, Marco
AU - Narbute, Inga
AU - Makkar, Raj R.
AU - Palacios, Igor F.
AU - Kim, Young Hak
AU - Buszman, Pawel E.
AU - Chakravarty, Tarun
AU - Sheiban, Imad
AU - Mehran, Roxana
AU - Naber, Christoph
AU - Margey, Ronan
AU - Agnihotri, Arvind
AU - Marra, Sebastiano
AU - Leon, Martin B.
AU - Moses, Jeffrey W.
AU - Fajadet, Jean
AU - Lefèvre, Thierry
AU - Morice, Marie Claude
AU - Erglis, Andrejs
AU - Alfieri, Ottavio
AU - Serruys, Patrick W.
AU - Colombo, Antonio
AU - Tamburino, Corrado
N1 - Publisher Copyright:
© 2016 American College of Cardiology Foundation
PY - 2016/11/28
Y1 - 2016/11/28
N2 - Objectives 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. Background 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. Methods 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. Results 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). Conclusions 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.
AB - Objectives 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. Background 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. Methods 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. Results 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). Conclusions 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.
KW - Andersen-Gill
KW - competing risk
KW - left main
KW - weighted composite event(s)
KW - win ratio
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U2 - 10.1016/j.jcin.2016.08.025
DO - 10.1016/j.jcin.2016.08.025
M3 - Article
C2 - 27884354
AN - SCOPUS:84997497725
SN - 1936-8798
VL - 9
SP - 2280
EP - 2288
JO - JACC: Cardiovascular Interventions
JF - JACC: Cardiovascular Interventions
IS - 22
ER -