Per results of the EXCEL trial, the relative 3-year and 30-day outcomes of percutaneous coronary intervention (PCI) with everolimus-eluting stents vs coronary artery bypass grafting (CABG) were consistent in people with and without diabetes with left main coronary artery disease, according to a study published in the Journal of the American College of Cardiology.
This prespecified subgroup analysis from the randomized EXCEL (Evaluation of XIENCE versus Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization; ClinicalTrials.gov identifier NCT01205776) trial was designed to examine the effect of diabetes in patients with left main coronary artery disease and low- or intermediate site-assessed SYNTAX scores ≥32 who were treated with CABG vs PCI (N=1905).
Patients were randomly assigned 1:1 to either CABG PCI with everolimus-eluting stents, and stratified by diabetes status (with diabetes, n=554; without diabetes, n=1350). The primary endpoint was the 3-year rate of stroke, myocardial infarction (MI), or all-cause mortality, with secondary outcomes of this endpoint at 30 days, as well as the composite rate of MI, stroke, ischemia-driven revascularization, or death at 3 years.
The composite 3-year primary endpoint was significantly higher in participants with diabetes compared with participants without diabetes (20% vs 12.9%; P <.001). The 3-year primary endpoint rate after treatment was similar between PCI and CABG in participants with diabetes (20.7% vs 19.3%, respectively; hazard ratio [HR], 1.03; 95% CI, 0.71-1.50; P =.87) and participants without diabetes (12.9% vs 12.9%, respectively; HR, 0.98; 95% CI, 0.73-1.32; P =.89).
Three-year all-cause death occurred in 9.0% patients who received CABG and 13.6% patients who received of PCI (P =.046), although no significant interaction was observed between diabetes status and any endpoint, including all-cause death treatment (P =.22), 3-year primary endpoint (P =.82), major secondary endpoints of stroke, MI, or all-cause mortality at 30-days (P =.61); or MI, stroke, ischemia-driven revascularization, or death at 3 years (P =.65).
The investigators concluded that “among both diabetic and nondiabetic patients with LMCAD and site-assessed low-to-intermediate (≤32) SYNTAX scores, PCI using [everolimus-eluting stents] and CABG resulted in similar rates of the primary composite endpoint of death, stroke, or MI at 3-year follow-up, although fewer adverse events at 30 days occurred after PCI. For [people with diabetes] with LMCAD and relatively noncomplex coronary anatomy, PCI may be a reasonable approach, whereas CABG should be considered for [people with diabetes] with more complex CAD.”
Disclosures: Multiple authors report affiliations with pharmaceutical companies. See the reference for complete disclosure information.
Milojevic M, Serruys PW, Sabik JF, et al. Bypass surgery or stenting for left main coronary artery disease in patients with diabetes. J Am Coll Cardiol. 2019;73:1616–1628.