Computing Methods for Composite Clinical Endpoints in Unprotected Left Main Coronary Artery Revascularization: A Post Hoc Analysis of the DELTA Registry

Davide Capodanno, Giuseppe Gargiulo, Sergio Buccheri, Alaide Chieffo, Emanuele Meliga, Azeem Latib, Seung-Jung Park, Yoshinobu Onuma, Piera Capranzano, Marco Valgimigli, Inga Narbute, Raj R. Makkar, Igor F. Palacios, Young-Hak Kim, Pawel E. Buszman, Tarun Chakravarty, Imad Sheiban, Roxana Mehran, Christoph Naber, Ronan MargeyArvind Agnihotri, Sebastiano Marra, Martin B. Leon, Jeffrey W. Moses, Jean Fajadet, Thierry Lefèvre, Marie-Claude Morice, Andrejs Erglis, Ottavio Alfieri, Patrick W. Serruys, Antonio Colombo, Corrado Tamburino

Research output: Contribution to journalArticle

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.
Original languageEnglish
Pages (from-to)2280 - 2288
Number of pages9
JournalJACC: Cardiovascular Interventions
Volume9
Issue number22
DOIs
Publication statusPublished - Nov 28 2016

Keywords

  • Andersen-Gill
  • competing risk
  • left main
  • weighted composite event(s)
  • win ratio

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

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    Capodanno, D., Gargiulo, G., Buccheri, S., Chieffo, A., Meliga, E., Latib, A., Park, S-J., Onuma, Y., Capranzano, P., Valgimigli, M., Narbute, I., Makkar, R. R., Palacios, I. F., Kim, Y-H., Buszman, P. E., Chakravarty, T., Sheiban, I., Mehran, R., Naber, C., ... Tamburino, C. (2016). Computing Methods for Composite Clinical Endpoints in Unprotected Left Main Coronary Artery Revascularization: A Post Hoc Analysis of the DELTA Registry. JACC: Cardiovascular Interventions, 9(22), 2280 - 2288. https://doi.org/10.1016/j.jcin.2016.08.025