Milan Milojevic1, Patrick W Serruys2, Joseph F Sabik3, David E Kandzari4, Erick Schampaert5, Ad J van Boven6, Ferenc Horkay7, Imre Ungi8, Samer Mansour9, Adrian P Banning10, David P Taggart10, Manel Sabaté11, Anthony H Gershlick12, Andrzej Bochenek13, Jose Pomar11, Nicholas J Lembo14, Nicolas Noiseux9, John D Puskas15, Aaron Crowley16, Ioanna Kosmidou17, Roxana Mehran18, Ori Ben-Yehuda17, Philippe Généreux19, Stuart J Pocock20, Charles A Simonton21, Gregg W Stone22, Arie Pieter Kappetein23. 1. Erasmus Medical Center, Rotterdam, the Netherlands. 2. Imperial College of Science, Technology and Medicine, London, United Kingdom. 3. UH Cleveland Medical Center, Cleveland, Ohio. 4. Piedmont Heart Institute, Atlanta, Georgia. Electronic address: https://twitter.com/kandzari. 5. Hôpital du Sacré-Coeur de Montréal, Montreal, Quebec, Canada. 6. Medical Center Leeuwarden, Leeuwarden, the Netherlands. 7. Semmelweis University, Budapest, Hungary. 8. University of Szeged, Szeged, Hungary. 9. Centre Hospitalier de l'Université de Montréal, Montreal, Quebec, Canada. 10. John Radcliffe Hospital, Oxford, United Kingdom. 11. Hospital Clinic, Barcelona, Spain. 12. Glenfield Hospital, Leicester, United Kingdom. 13. American Heart of Poland, Katowice, Poland. 14. NewYork-Presbyterian Hospital/Columbia University Medical Center, New York, New York. 15. Mount Sinai Heart at Mount Sinai Saint Luke's, New York, New York. 16. Clinical Trials Center, Cardiovascular Research Foundation, New York, New York. 17. NewYork-Presbyterian Hospital/Columbia University Medical Center, New York, New York; Clinical Trials Center, Cardiovascular Research Foundation, New York, New York. 18. Clinical Trials Center, Cardiovascular Research Foundation, New York, New York; The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York. Electronic address: https://twitter.com/Drroxmehran. 19. Hôpital du Sacré-Coeur de Montréal, Montreal, Quebec, Canada; Clinical Trials Center, Cardiovascular Research Foundation, New York, New York; Gagnon Cardiovascular Institute, Morristown Medical Center, Morristown, New Jersey. Electronic address: https://twitter.com/philgenereux. 20. London School of Hygiene and Tropical Medicine, London, United Kingdom. 21. Abbott Vascular, Santa Clara, California. Electronic address: https://twitter.com/DrChuckSimonton. 22. NewYork-Presbyterian Hospital/Columbia University Medical Center, New York, New York; Clinical Trials Center, Cardiovascular Research Foundation, New York, New York. Electronic address: https://twitter.com/GreggWStone. 23. Erasmus Medical Center, Rotterdam, the Netherlands. Electronic address: a.kappetein@erasmusmc.nl.
Abstract
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 withpercutaneous 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 diabeticpatients (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 CABGpatients (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).
RCT Entities:
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 nondiabeticpatients (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 diabeticpatients (20.7% vs. 19.3%, respectively; hazard ratio: 1.03; 95% confidence interval: 0.71 to 1.50; p = 0.87) and nondiabeticpatients (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 nondiabeticpatients 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).
Authors: Bilal R Bawamia; Mohaned Egred; Matthew Jackson; Ian Purcell; David Austin; Azfar G Zaman Journal: Catheter Cardiovasc Interv Date: 2020-03-05 Impact factor: 2.692
Authors: T M Hommels; R S Hermanides; B Berta; E Fabris; G De Luca; E H Ploumen; C von Birgelen; E Kedhi Journal: Cardiovasc Diabetol Date: 2020-10-02 Impact factor: 9.951