Bypass surgery or stenting for left main coronary artery disease in patients with diabetes

Background The randomized EXCEL (Evaluation of XIENCE versus Coronary Arteryandnbsp;Bypass Surgeryandnbsp;for Effectiveness of Left Main Revascularization) trial reported a similar rate of the 3-year composite primary endpoint ofandnbsp;death,andnbsp;myocardial infarctionandnbsp;(MI), orandnbsp;strokeandnbsp;in patients with left mainandnbsp;coronary artery diseaseandnbsp;(LMCAD) and site-assessed low or intermediateandnbsp;SYNTAX scoresandnbsp;treated withandnbsp;percutaneous coronary interventionandnbsp;(PCI) and coronary artery bypass grafting (CABG). Whether these results are consistent in high-riskandnbsp;patients with diabetes, who have fared relatively better with CABG in most prior trials, is unknown. Objectives In this pre-specifiedandnbsp;subgroup analysisandnbsp;from the EXCEL trial, the authors sought to examine the effect ofandnbsp;diabetesandnbsp;in patients with LMCAD treated with PCI versus CABG. Methods Patients (Nandnbsp;=andnbsp;1,905) with LMCAD and site-assessed low or intermediate CAD complexity (SYNTAX scoresandnbsp;andle;32) were randomized 1:1 to PCI with everolimus-elutingandnbsp;stentsandnbsp;versus CABG, stratified by the presence ofandnbsp;diabetes. The primary endpoint was the rate of a composite of all-causeandnbsp;death,andnbsp;stroke, or MI at 3 years. Outcomes were examined in patients with (nandnbsp;=andnbsp;554) and without (nandnbsp;=andnbsp;1,350) diabetes. Results The 3-year composite primary endpoint was significantly higher in diabetic compared with nondiabetic patients (20.0% vs. 12.9%; pandnbsp;andlt; 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;andnbsp;hazard ratio: 1.03; 95%andnbsp;confidence interval: 0.71 to 1.50; pandnbsp;=andnbsp;0.87) and nondiabetic patients (12.9% vs. 12.9%, respectively;andnbsp;hazard ratio: 0.98; 95% confidence interval: 0.73 to 1.32; pandnbsp;=andnbsp;0.89). All-cause death at 3 years occurred in 13.6% of PCI and 9.0% of CABG patients (pandnbsp;=andnbsp;0.046), although no significant interaction was present between diabetes status and treatment for all-cause death (pandnbsp;=andnbsp;0.22) or other endpoints, including the 3-year primary endpoint (pandnbsp;=andnbsp;0.82) or the major secondary endpoints of death, MI, or stroke at 30andnbsp;days (pandnbsp;=andnbsp;0.61) or death, MI, stroke, or ischemia-driven revascularization at 3 years (pandnbsp;=andnbsp;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 intermediateandnbsp;SYNTAX scores.(Evaluation of XIENCE versusandnbsp;Coronary Artery Bypassandnbsp;Surgery for Effectiveness of Left Mainandnbsp;Revascularizationandnbsp;[EXCEL];andnbsp;NCT01205776)