1. Computing Methods for Composite Clinical Endpoints in Unprotected Left Main Coronary Artery Revascularization: A Post Hoc Analysis of the DELTA Registry.
- Author
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Capodanno D, Gargiulo G, Buccheri S, Chieffo A, Meliga E, Latib A, Park SJ, Onuma Y, Capranzano P, Valgimigli M, Narbute I, Makkar RR, Palacios IF, Kim YH, Buszman PE, Chakravarty T, Sheiban I, Mehran R, Naber C, Margey R, Agnihotri A, Marra S, Leon MB, Moses JW, Fajadet J, Lefèvre T, Morice MC, Erglis A, Alfieri O, Serruys PW, Colombo A, and Tamburino C
- Subjects
- Aged, Cerebrovascular Disorders etiology, Coronary Artery Bypass adverse effects, Coronary Artery Bypass mortality, Coronary Artery Disease diagnosis, Coronary Artery Disease mortality, Data Interpretation, Statistical, Drug-Eluting Stents, Endpoint Determination statistics & numerical data, Female, Humans, Kaplan-Meier Estimate, Logistic Models, Male, Markov Chains, Middle Aged, Multivariate Analysis, Myocardial Infarction etiology, Percutaneous Coronary Intervention adverse effects, Percutaneous Coronary Intervention instrumentation, Percutaneous Coronary Intervention mortality, Propensity Score, Proportional Hazards Models, Risk Assessment, Risk Factors, Time Factors, Treatment Outcome, Coronary Artery Bypass statistics & numerical data, Coronary Artery Disease therapy, Models, Statistical, Percutaneous Coronary Intervention statistics & numerical data, Registries statistics & numerical data, Research Design statistics & numerical data
- Abstract
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., (Copyright © 2016 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)
- Published
- 2016
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