Author + information
- Milan Milojevic, MD, MSca,
- Patrick W. Serruys, MD, PhDb,
- Joseph F. Sabik III, MDc,
- David E. Kandzari, MDd@kandzari,
- Erick Schampaert, MDe,
- Ad J. van Boven, MD, PhDf,
- Ferenc Horkay, MD, PhD, DScg,
- Imre Ungi, MD, PhDh,
- Samer Mansour, MDi,
- Adrian P. Banning, MDj,
- David P. Taggart, MD, PhDj,
- Manel Sabaté, MD, PhDk,
- Anthony H. Gershlick, MBBSl,
- Andrzej Bochenek, MD, PhDm,
- Jose Pomar, MD, PhDk,
- Nicholas J. Lembo, MDn,
- Nicolas Noiseux, MDi,
- John D. Puskas, MDo,
- Aaron Crowley, MAp,
- Ioanna Kosmidou, MD, PhDn,p,
- Roxana Mehran, MDp,q@Drroxmehran,
- Ori Ben-Yehuda, MDn,p,
- Philippe Généreux, MDe,p,r@philgenereux,
- Stuart J. Pocock, PhDs,
- Charles A. Simonton, MDt@DrChuckSimonton,
- Gregg W. Stone, MDn,p@GreggWStone and
- Arie Pieter Kappetein, MD, PhDa,∗ (, )@AKappetein
- aErasmus Medical Center, Rotterdam, the Netherlands
- bImperial College of Science, Technology and Medicine, London, United Kingdom
- cUH Cleveland Medical Center, Cleveland, Ohio
- dPiedmont Heart Institute, Atlanta, Georgia
- eHôpital du Sacré-Coeur de Montréal, Montreal, Quebec, Canada
- fMedical Center Leeuwarden, Leeuwarden, the Netherlands
- gSemmelweis University, Budapest, Hungary
- hUniversity of Szeged, Szeged, Hungary
- iCentre Hospitalier de l’Université de Montréal, Montreal, Quebec, Canada
- jJohn Radcliffe Hospital, Oxford, United Kingdom
- kHospital Clinic, Barcelona, Spain
- lGlenfield Hospital, Leicester, United Kingdom
- mAmerican Heart of Poland, Katowice, Poland
- nNewYork-Presbyterian Hospital/Columbia University Medical Center, New York, New York
- oMount Sinai Heart at Mount Sinai Saint Luke’s, New York, New York
- pClinical Trials Center, Cardiovascular Research Foundation, New York, New York
- qThe Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York
- rGagnon Cardiovascular Institute, Morristown Medical Center, Morristown, New Jersey
- sLondon School of Hygiene and Tropical Medicine, London, United Kingdom
- tAbbott Vascular, Santa Clara, California
- ↵∗Address for correspondence:
Prof. Arie Pieter Kappetein, Department of Cardio-Thoracic Surgery, Erasmus University Medical Center, P.O. Box 2040, 3000 CA Rotterdam, the Netherlands.
Background The randomized EXCEL (Evaluation of XIENCE versus Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization) trial reported a similar rate of the 3-year composite primary endpoint of death, myocardial infarction (MI), or stroke in patients with left main coronary artery disease (LMCAD) and site-assessed low or intermediate SYNTAX scores treated with percutaneous coronary intervention (PCI) and coronary artery bypass grafting (CABG). Whether these results are consistent in high-risk patients with diabetes, who have fared relatively better with CABG in most prior trials, is unknown.
Objectives In this pre-specified subgroup analysis from the EXCEL trial, the authors sought to examine the effect of diabetes in patients with LMCAD treated with PCI versus CABG.
Methods Patients (N = 1,905) with LMCAD and site-assessed low or intermediate CAD complexity (SYNTAX scores ≤32) were randomized 1:1 to PCI with everolimus-eluting stents versus CABG, stratified by the presence of diabetes. The primary endpoint was the rate of a composite of all-cause death, stroke, or MI at 3 years. Outcomes were examined in patients with (n = 554) and without (n = 1,350) diabetes.
Results The 3-year composite primary endpoint was significantly higher in diabetic compared with nondiabetic patients (20.0% vs. 12.9%; p < 0.001). The rate of the 3-year primary endpoint was similar after treatment with PCI and CABG in diabetic patients (20.7% vs. 19.3%, respectively; hazard ratio: 1.03; 95% confidence interval: 0.71 to 1.50; p = 0.87) and nondiabetic patients (12.9% vs. 12.9%, respectively; hazard ratio: 0.98; 95% confidence interval: 0.73 to 1.32; p = 0.89). All-cause death at 3 years occurred in 13.6% of PCI and 9.0% of CABG patients (p = 0.046), although no significant interaction was present between diabetes status and treatment for all-cause death (p = 0.22) or other endpoints, including the 3-year primary endpoint (p = 0.82) or the major secondary endpoints of death, MI, or stroke at 30 days (p = 0.61) or death, MI, stroke, or ischemia-driven revascularization at 3 years (p = 0.65).
Conclusions In the EXCEL trial, the relative 30-day and 3-year outcomes of PCI with everolimus-eluting stents versus CABG were consistent in diabetic and nondiabetic patients with LMCAD and site-assessed low or intermediate SYNTAX scores.(Evaluation of XIENCE versus Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization [EXCEL]; NCT01205776)
- coronary artery bypass grafting
- left main disease
- percutaneous coronary intervention
- SYNTAX score
Dr. Banning is partially funded by the NHS Oxford NIHR Biomedical Research Centre. Dr. Serruys has been a consultant to Abbott, Biosensors, Medtronic, Micell Technologies, QualiMed, SINOMED, St. Jude Medical, Stentys, Svelte, Philips/Volcano, and Xeltis. Dr. Sabik has been a consultant to Medtronic, Edwards, and Sorin; and has served on the advisory board of Medtronic Cardiac Surgery. Dr. Kandzari has received consulting fees from Medtronic Biotronik, and Boston Scientific; and has received research support from Medtronic, Abbott Vascular, Boston Scientific, Biotronik, and Medinol. Dr. Schampaert has been a consultant and/or speaker for Abbott Vascular, Boston Scientific, and Philips Medical; and has been an advisory board member for Abbott, AstraZeneca, Bayer, and Servier. Dr. Mansour has received research support and speaker honoraria from Abbott Vascular. Dr. Banning has received institutional grant support for a research fellowship from Boston Scientific; and has received lecture fees from Boston Scientific and Abbott Vascular. Dr. Sabaté has been a consultant for Abbott Vascular. Dr. Lembo has been a consultant to Abbott Vascular; and has served on the Speakers Bureau for Abbott Vascular, Boston Scientific, and Medtronic. Dr. Mehran has received institutional research grant support from Eli Lilly/Daiichi-Sankyo, Bristol-Myers Squibb, AstraZeneca, OrbusNeich, Bayer, CSL Behring, Abbott Laboratories, Watermark Research Partners, Novartis Pharmaceuticals, Medtronic, AUM Cardiovascular, and Beth Israel Deaconess Medical Center; has served on executive committees for Janssen Pharmaceuticals, and Osprey Medical; has served on a data safety monitoring board for Watermark Research Partners; has been a consultant to Abbott, Medscape, Boston Scientific, Merck & Company, Cardiovascular Systems, Inc. (CSI), Regeneron, Roivant Sciences, Spectranetics/Phillips/Volcano, Sanofi USA, Siemens, Shanghai BraccoSine Pharmaceutical Corp. and AstraZeneca; has equity in Claret Medical and Elixir Medical Corporation; and her spouse has been a consultant to Abiomed and The Medicines Company. Dr. Généreux has received speaker fees from Abbott Vascular, Edwards Lifesciences, Medtronic, Tryton Medical, Cardinal Health, and Cardiovascular Systems Inc.; has received consulting fees from Abbott Vascular, Boston Scientific, Cardiovascular Systems Inc., and Pi-Cardia; has received an institutional research grant from Boston Scientific; and holds equity in SIG.NUM, SoundBite Medical Solutions, Saranas, and Pi-Cardia. Dr. Pocock has been a consultant to Abbott Vascular. Dr. Simonton is an employee of Abbott Vascular. Dr. Stone has been a consultant to Matrizyme, Miracor, Neovasc, V-wave, Shockwave, Valfix, TherOx, Reva, Vascular Dynamics, Robocath, HeartFlow, Gore, Ablative Solutions and Ancora; has received speaker honoraria from Amaranth and Terumo; holds equity/options in Ancora, Cagent, Qool Therapeutics, Aria, Caliber, MedFocus family of funds, Biostar family of funds, Applied Therapeutics, and SpectraWAVE; and his employer, Columbia University, receives royalties for sale of the MitraClip. Prof. Kappetein is an employee of Medtronic. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
Listen to this manuscript's audio summary by Editor-in-Chief Dr. Valentin Fuster on JACC.org.
- Received December 4, 2018.
- Accepted January 1, 2019.
This article requires a subscription or purchase to view the full text. If you are a subscriber or member, click Login or the Subscribe link (top menu above) to access this article.