Davide Capodanno1, Giuseppe Gargiulo2, Sergio Buccheri3, Alaide Chieffo4, Emanuele Meliga5, Azeem Latib4, Seung-Jung Park6, Yoshinobu Onuma7, Piera Capranzano3, Marco Valgimigli8, Inga Narbute9, Raj R Makkar10, Igor F Palacios11, Young-Hak Kim6, Pawel E Buszman12, Tarun Chakravarty10, Imad Sheiban13, Roxana Mehran14, Christoph Naber15, Ronan Margey10, Arvind Agnihotri11, Sebastiano Marra13, Martin B Leon16, Jeffrey W Moses16, Jean Fajadet17, Thierry Lefèvre18, Marie-Claude Morice18, Andrejs Erglis9, Ottavio Alfieri4, Patrick W Serruys7, Antonio Colombo4, Corrado Tamburino3. 1. Cardio-Thoracic-Vascular Department, Ferrarotto Hospital, University of Catania, Catania, Italy. Electronic address: dcapodanno@gmail.com. 2. Cardio-Thoracic-Vascular Department, Ferrarotto Hospital, University of Catania, Catania, Italy; Department of Advanced Biomedical Sciences, Federico II University of Naples, Naples, Italy. 3. Cardio-Thoracic-Vascular Department, Ferrarotto Hospital, University of Catania, Catania, Italy. 4. Department of Cardio-Thoracic and Vascular Diseases, San Raffaele Scientific Institute, Milan, Italy. 5. Interventional Cardiology Unit, A. O. Ordine Mauriziano Umberto I, Turin, Italy. 6. Department of Cardiology, Center for Medical Research and Information, University of Ulsan College of Medicine, Asan Medical Center, Seoul, South Korea. 7. Thoraxcenter, Erasmus Medical Center, Rotterdam, the Netherlands. 8. Bern University Hospital, Bern, Switzerland. 9. Latvian Centre of Cardiology, Pauls Stradins Clinical University Hospital, and Institute of Cardiology, University of Latvia, Riga, Latvia. 10. Cedars-Sinai Heart Institute, Cedars-Sinai Medical Center, Los Angeles, California. 11. Cardiac Catheterization Laboratory, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts. 12. Center for Cardiovascular Research and Development of American Heart of Poland, Katowice, Poland. 13. Interventional Cardiology, Division of Cardiology, University of Turin, S. Giovanni Battista Molinette Hospital, Turin, Italy. 14. Mount-Sinai Medical Center, New York, New York. 15. Klinik für Kardiologie und Angiologie, Elisabeth-Krankenhaus, Essen, Germany. 16. Columbia University Medical Center and Cardiovascular Research Foundation, New York, New York. 17. Clinique Pasteur, Toulouse, France. 18. Hopital privé Jacques Cartier, Ramsay Générale de Santé, Massy, France.
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.
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 ULMCApatients 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.
Authors: Marcelo Harada Ribeiro; Carlos M Campos; Lucio Padilla; Antonio Carlos B da Silva; João Eduardo T de Paula; Marco Alcantara; Ricardo Santiago; Franklin Hanna; Franciele R da Silva; Karlyse C Belli; Lorenzo Azzalini; Pedro P de Oliveira; Gustavo N Araujo; Vincenzo Sucato; Kambis Mashayekhi; Alfredo R Galassi; Alexandre Abizaid; Alexandre Quadros Journal: J Am Heart Assoc Date: 2022-06-03 Impact factor: 6.106
Authors: Charlie McLeod; Richard Norman; Edward Litton; Benjamin R Saville; Steve Webb; Thomas L Snelling Journal: Contemp Clin Trials Commun Date: 2019-11-12