PCI with everolimus-eluting stents yielded similar 3-year rates of death, stroke, or MI compared to CABG in diabetic patients with LMCAD (HR 1.03; 95% CI 0.71-1.50; P=0.87).
RCT (n=1,905)
1:1
Yes
Does percutaneous coronary intervention with everolimus-eluting stents reduce the composite of all-cause death, stroke, or MI at 3 years compared to coronary artery bypass grafting in patients with left main coronary artery disease and low or intermediate SYNTAX scores, particularly those with diabetes?
In patients with left main coronary artery disease and low or intermediate SYNTAX scores, PCI and CABG yielded similar 3-year composite outcomes of death, MI, or stroke, regardless of diabetes status.
Effect estimate: HR 1.03 (95% CI 0.71 to 1.50)
Absolute Event Rate: 20.7% vs 19.3%
p-value: p=0.87
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 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 = 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 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 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).
Milojevic et al. (2019) conducted an RCT in Left main coronary artery disease (LMCAD) (n=1,905). PCI with everolimus-eluting stents vs. CABG was evaluated on Composite of all-cause death, stroke, or MI at 3 years (HR 1.03, 95% CI 0.71 to 1.50, p=0.87). PCI with everolimus-eluting stents yielded similar 3-year rates of death, stroke, or MI compared to CABG in diabetic patients with LMCAD (HR 1.03; 95% CI 0.71-1.50; P=0.87).