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 ¼ 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 ¼ 554) and without (n ¼ 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 ¼ 0.87) and nondiabetic patients (12.9% vs. 12.9%, respectively; hazard ratio: 0.98; 95% confidence interval: 0.73 to 1.32; p ¼ 0.89). All-cause death at 3 years occurred in 13.6% of PCI and 9.0% of CABG patients (p ¼ 0.046), although no significant interaction was present between diabetes status and treatment for all-cause death (p ¼ 0.22) or other endpoints, including the 3-year primary endpoint (p ¼ 0.82) or the major secondary endpoints of death, MI, or stroke at 30 days (p ¼ 0.61) or death, MI, stroke, or ischemia-driven revascularization at 3 years (p ¼ 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) (J Am Coll Cardiol 2019;73:1616–28) © 2019 Published by Elsevier on behalf of the American College of Cardiology Foundation.

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Persistent URL dx.doi.org/10.1016/j.jacc.2019.01.037, hdl.handle.net/1765/116244
Journal Journal of the American College of Cardiology
Citation
Milojevic, M., Serruys, P.W.J.C, Sabik, J.F, Kandzari, D.E, Schampaert, E., van Boven, A.J, … Kappetein, A.P. (2019). Bypass Surgery or Stenting for Left Main Coronary Artery Disease in Patients With Diabetes. Journal of the American College of Cardiology, 73(13), 1616–1628. doi:10.1016/j.jacc.2019.01.037