Gennaro Giustino1, Roxana Mehran2, Patrick W Serruys3, Joseph F Sabik4, Milan Milojevic5, Charles A Simonton6, John D Puskas7, David E Kandzari8, Marie-Claude Morice9, David P Taggart10, Anthony H Gershlick11, Philippe Généreux12, Zixuan Zhang13, Thomas McAndrew13, Björn Redfors13, Michael Ragosta14, Irving L Kron14, Ovidiu Dressler13, Martin B Leon15, Stuart J Pocock16, Ori Ben-Yehuda15, Arie Pieter Kappetein5, Gregg W Stone17. 1. The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York; Clinical Trials Center, Cardiovascular Research Foundation, New York, New York. Electronic address: https://twitter.com/g_giustinoMD. 2. The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York; Clinical Trials Center, Cardiovascular Research Foundation, New York, New York. Electronic address: https://twitter.com/Drroxmehran. 3. Imperial College of Science, Technology and Medicine, London, United Kingdom. 4. Department of Surgery, UH Cleveland Medical Center, Cleveland, Ohio. 5. Erasmus University Medical Center, Rotterdam, the Netherlands. 6. Abbott Vascular, Santa Clara, California. 7. Mount Sinai Heart at Mount Sinai St. Luke's, New York, New York. 8. Piedmont Heart Institute, Atlanta, Georgia. 9. Ramsay Générale de Santé, Hopital Privé Jacques Cartier, Massy, France. 10. Department Cardiac Surgery, John Radcliffe Hospital, Oxford, United Kingdom. 11. University Hospitals of Leicester, Leicester, United Kingdom. 12. Clinical Trials Center, Cardiovascular Research Foundation, New York, New York; Gagnon Cardiovascular Institute, Morristown Medical Center, Morristown, New Jersey; Hôpital du Sacré-Coeur de Montréal, Montréal, Québec, Canada. 13. Clinical Trials Center, Cardiovascular Research Foundation, New York, New York. 14. Division of Cardiovascular Medicine, University of Virginia Health System, Charlottesville, Virginia. 15. Clinical Trials Center, Cardiovascular Research Foundation, New York, New York; New York-Presbyterian Hospital/Columbia University Medical Center, New York, New York. 16. London School of Hygiene and Tropical Medicine, London, United Kingdom. 17. Clinical Trials Center, Cardiovascular Research Foundation, New York, New York; New York-Presbyterian Hospital/Columbia University Medical Center, New York, New York. Electronic address: gs2184@columbia.edu.
Abstract
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 forLMCAD 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).
RCT Entities:
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).
Authors: Gil Moskowitz; Kimberly N Hong; Gennaro Giustino; A Marc Gillinov; Gorav Ailawadi; Joseph J DeRose; Alexander Iribarne; Alan J Moskowitz; Annetine C Gelijns; Natalia N Egorova Journal: J Am Coll Cardiol Date: 2019-11-26 Impact factor: 24.094
Authors: Felix Mahfoud; Ahmed Farah; Marc-Alexander Ohlow; Norman Mangner; Jochen Wöhrle; Sven Möbius-Winkler; Daniel Weilenmann; Gregor Leibundgut; Florim Cuculi; Nicole Gilgen; Christoph Kaiser; Marco Cattaneo; Bruno Scheller; Raban V Jeger Journal: Clin Res Cardiol Date: 2022-02-27 Impact factor: 6.138
Authors: Sean S Scholz; Lucas Lauder; Sebastian Ewen; Saarraaken Kulenthiran; Nikolaus Marx; Orazbek Sakhov; Floris Kauer; Adam Witkowski; Marco Vaglimigli; William Wijns; Bruno Scheller; Michael Böhm; Felix Mahfoud Journal: Clin Res Cardiol Date: 2019-12-02 Impact factor: 5.460