Author + information
- Received March 16, 2018
- Revision received April 26, 2018
- Accepted May 11, 2018
- Published online August 6, 2018.
- Gennaro Giustino, MDa,b@g_giustinoMD,
- Roxana Mehran, MDa,b@Drroxmehran,
- Patrick W. Serruys, MD, PhDc,
- Joseph F. Sabik III, MDd,
- Milan Milojevic, MD, MSce,
- Charles A. Simonton, MDf,
- John D. Puskas, MDg,
- David E. Kandzari, MDh,
- Marie-Claude Morice, MDi,
- David P. Taggart, MDj,
- Anthony H. Gershlick, MDk,
- Philippe Généreux, MDb,l,m,
- Zixuan Zhang, MSb,
- Thomas McAndrew, PhDb,
- Björn Redfors, MD, PhDb,
- Michael Ragosta III, MDn,
- Irving L. Kron, MDn,
- Ovidiu Dressler, MDb,
- Martin B. Leon, MDb,o,
- Stuart J. Pocock, PhDp,
- Ori Ben-Yehuda, MDb,o,
- Arie Pieter Kappetein, MD, PhDe and
- Gregg W. Stone, MDb,o,∗ (, )@GreggWStone
- aThe Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York
- bClinical Trials Center, Cardiovascular Research Foundation, New York, New York
- cImperial College of Science, Technology and Medicine, London, United Kingdom
- dDepartment of Surgery, UH Cleveland Medical Center, Cleveland, Ohio
- eErasmus University Medical Center, Rotterdam, the Netherlands
- fAbbott Vascular, Santa Clara, California
- gMount Sinai Heart at Mount Sinai St. Luke’s, New York, New York
- hPiedmont Heart Institute, Atlanta, Georgia
- iRamsay Générale de Santé, Hopital Privé Jacques Cartier, Massy, France
- jDepartment Cardiac Surgery, John Radcliffe Hospital, Oxford, United Kingdom
- kUniversity Hospitals of Leicester, Leicester, United Kingdom
- lGagnon Cardiovascular Institute, Morristown Medical Center, Morristown, New Jersey
- mHôpital du Sacré-Coeur de Montréal, Montréal, Québec, Canada
- nDivision of Cardiovascular Medicine, University of Virginia Health System, Charlottesville, Virginia
- oNew York-Presbyterian Hospital/Columbia University Medical Center, New York, New York
- pLondon School of Hygiene and Tropical Medicine, London, United Kingdom
- ↵∗Address for correspondence:
Dr. Gregg W. Stone, Columbia University Medical Center, Cardiovascular Research Foundation, 1700 Broadway, 8th Floor, New York, New York 10019.
Background The optimal revascularization strategy for patients with left main coronary artery disease (LMCAD) and chronic kidney disease (CKD) remains unclear.
Objectives This study investigated the comparative effectiveness of percutaneous coronary intervention (PCI) versus coronary artery bypass graft (CABG) surgery in patients with LMCAD and low or intermediate anatomical complexity according to baseline renal function from the multicenter randomized EXCEL (Evaluation of XIENCE Versus Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization) trial.
Methods CKD was defined as an estimated glomerular filtration rate <60 ml/min/1.73 m2 using the CKD Epidemiology Collaboration equation. Acute renal failure (ARF) was defined as a serum creatinine increase ≥5.0 mg/dl from baseline or a new requirement for dialysis. The primary composite endpoint was the composite of death, myocardial infarction (MI), or stroke at 3-year follow-up.
Results CKD was present in 361 of 1,869 randomized patients (19.3%) in whom baseline estimated glomerular filtration rate was available. Patients with CKD had higher 3-year rates of the primary endpoint compared with those without CKD (20.8% vs. 13.5%; hazard ratio [HR]: 1.60; 95% confidence interval [CI]: 1.22 to 2.09; p = 0.0005). ARF within 30 days occurred more commonly in patients with compared with those without CKD (5.0% vs. 0.8%; p < 0.0001), and was strongly associated with the 3-year risk of death, stroke, or MI (50.7% vs. 14.4%; HR: 4.59; 95% CI: 2.73 to 7.73; p < 0.0001). ARF occurred less commonly after revascularization with PCI compared with CABG both in patients with CKD (2.3% vs. 7.7%; HR: 0.28; 95% CI: 0.09 to 0.87) and in those without CKD (0.3% vs. 1.3%; HR: 0.20; 95% CI: 0.04 to 0.90; pinteraction = 0.71). There were no significant differences in the rates of the primary composite endpoint after PCI and CABG in patients with CKD (23.4% vs. 18.1%; HR: 1.25; 95% CI: 0.79 to 1.98) and without CKD (13.4% vs. 13.5%; HR: 0.97; 95% CI: 0.73 to 1.27; pinteraction = 0.38).
Conclusions Patients with CKD undergoing revascularization for LMCAD in the EXCEL trial had increased rates of ARF and reduced event-free survival. ARF occurred less frequently after PCI compared with CABG. There were no significant differences between PCI and CABG in terms of death, stroke, or MI at 3 years in patients with and without CKD. (EXCEL Clinical Trial [EXCEL]; NCT01205776)
- chronic kidney disease
- coronary artery bypass grafting
- coronary artery disease
- left main
- percutaneous coronary intervention
Dr. Mehran has received institutional research grant support from Eli Lilly/Daiichi-Sankyo, Bristol-Myers Squibb, AstraZeneca, The Medicines Company, OrbusNeich, Bayer, CSL Behring, Abbott Laboratories, Watermark Research Partners, Novartis Pharmaceuticals, Medtronic, AUM Cardiovascular, and Beth Israel Deaconess Medical Center; has served on the executive committee of Janssen Pharmaceuticals and Osprey Medical.; has served on the data safety monitoring board of Watermark Research Partners; has served as a consultant to Medscape, The Medicines Company, Boston Scientific, Merck & Company, Cardiovascular Systems, Inc., Sanofi USA, Shanghai BraccoSine Pharmaceutical Corp., and AstraZeneca; has a spouse who has served as a consultant to The Medicines Company and Abiomed; and has equity in Claret Medical Inc. and Elixir Medical Corporation. Dr. Serruys has served as a consultant to Abbott, Biosensors, Medtronic, Micell Technologies, QualiMed, SINOMED, St. Jude Medical, Stentys, Svelte, Philips/Volcano, and Xeltis. Dr. Sabik has served as a consultant to Medtronic, Edwards, and Sorin; has served on the advisory board of Medtronic Cardiac Surgery; and has served as North American surgical principal investigator for the EXCEL Trial sponsored by Abbott. Dr. Simonton is an employee of Abbott Vascular. Dr. Kandzari has served as a consultant to Medtronic, Boston Scientific, Biotronik, Micell Technologies, and Cardinal Health; and has received institutional research/grant support from Medtronic, Boston Scientific, Biotronik, Micell Technologies, and Medinol. Dr. Gershlick has received lecture fees from Abbott Vascular. Dr. Genereux has received speaker fees from Edwards Lifesciences, Medtronic, Tryton Medical Inc., Cardinal Health, and Cardiovascular Systems Inc.; has received consulting fees from Boston Scientific, Cardiovascular Systems Inc., and Pi-Cardia; has received an institutional research grant from Boston Scientific; and has equity in SIG.NUM, SoundBite Medical Solutions, Saranas, and Pi-Cardia. Dr. Pocock has served as a consultant to Abbott Vascular. Dr. Kappetein is an employee of Medtronic. Dr. Stone’s employer, Columbia University, receives royalties for sale of the MitraClip. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
- Received March 16, 2018.
- Revision received April 26, 2018.
- Accepted May 11, 2018.
- 2018 American College of Cardiology Foundation
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