Author + information
- Received June 20, 2016
- Revision received July 25, 2016
- Accepted August 17, 2016
- Published online November 28, 2016.
- Davide Capodanno, MD, PhDa,∗ (, )
- Giuseppe Gargiulo, MDa,b,
- Sergio Buccheri, MDa,
- Alaide Chieffo, MDc,
- Emanuele Meliga, MDd,
- Azeem Latib, MDc,
- Seung-Jung Park, MDe,
- Yoshinobu Onuma, MDf,
- Piera Capranzano, MDa,
- Marco Valgimigli, MDg,
- Inga Narbute, MDh,
- Raj R. Makkar, MDi,
- Igor F. Palacios, MDj,
- Young-Hak Kim, MDe,
- Pawel E. Buszman, MDk,
- Tarun Chakravarty, MDi,
- Imad Sheiban, MDl,
- Roxana Mehran, MDm,
- Christoph Naber, MDn,
- Ronan Margey, MDi,
- Arvind Agnihotri, MDj,
- Sebastiano Marra, MDl,
- Martin B. Leon, MDo,
- Jeffrey W. Moses, MDo,
- Jean Fajadet, MDp,
- Thierry Lefèvre, MDq,
- Marie-Claude Morice, MDq,
- Andrejs Erglis, MDh,
- Ottavio Alfieri, MDc,
- Patrick W. Serruys, MDf,
- Antonio Colombo, MDc,
- Corrado Tamburino, MDa,
- DELTA Investigators
- aCardio-Thoracic-Vascular Department, Ferrarotto Hospital, University of Catania, Catania, Italy
- bDepartment of Advanced Biomedical Sciences, Federico II University of Naples, Naples, Italy
- cDepartment of Cardio-Thoracic and Vascular Diseases, San Raffaele Scientific Institute, Milan, Italy
- dInterventional Cardiology Unit, A. O. Ordine Mauriziano Umberto I, Turin, Italy
- eDepartment of Cardiology, Center for Medical Research and Information, University of Ulsan College of Medicine, Asan Medical Center, Seoul, South Korea
- fThoraxcenter, Erasmus Medical Center, Rotterdam, the Netherlands
- gBern University Hospital, Bern, Switzerland
- hLatvian Centre of Cardiology, Pauls Stradins Clinical University Hospital, and Institute of Cardiology, University of Latvia, Riga, Latvia
- iCedars-Sinai Heart Institute, Cedars-Sinai Medical Center, Los Angeles, California
- jCardiac Catheterization Laboratory, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts
- kCenter for Cardiovascular Research and Development of American Heart of Poland, Katowice, Poland
- lInterventional Cardiology, Division of Cardiology, University of Turin, S. Giovanni Battista Molinette Hospital, Turin, Italy
- mMount-Sinai Medical Center, New York, New York
- nKlinik für Kardiologie und Angiologie, Elisabeth-Krankenhaus, Essen, Germany
- oColumbia University Medical Center and Cardiovascular Research Foundation, New York, New York
- pClinique Pasteur, Toulouse, France
- qHopital privé Jacques Cartier, Ramsay Générale de Santé, Massy, France
- ↵∗Reprint requests and correspondence:
Prof. Davide Capodanno, Cardio-Thoracic-Vascular Department, Division of Cardiology, Ferrarotto Hospital, University of Catania, Via Citelli 6, Catania 95100, Italy.
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.
Dr. Gargiulo has received research grant support from the European Association of Percutaneous Cardiovascular Intervention and from the CardioPaTh PhD program at Federico II University of Naples. Dr. Makkar has served as a consultant for Abbott Vascular, Cordis, and Medtronic. Dr. Fajadet has received educational grant support from Abbott Vascular, Boston Scientific, Medtronic, and Terumo. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose. Drs. Capodanno and Gargiulo contributed equally to this work.
- Received June 20, 2016.
- Revision received July 25, 2016.
- Accepted August 17, 2016.
- American College of Cardiology Foundation