This study especially designed to compare PCI vs. CABG in patients with left main coronary artery disease and low to intermediate Syntax score showed that 30-day and 3 -year outcomes of PCI with everolimus eluting stents vs CABG were consistent both in diabetic and non-diabetic patients.
The randomized EXCEL trial (Evaluation of XIENCE versus Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization) reports a similar combined events rate (death, myocardial infarction or stroke) at 3 years in patients with left main lesion and low to intermediate Syntax score treated with PCI or CABG. This global data (published in the New England Journal of Medicine (NEJM) in 2016 and commented on our website) could be different por diabetics, who are at higher risk and have historically seen better benefits from surgery, as showed by the vast number of prior studies.
This is why this EXCEL sub-study has come as a surprise, seeing as it was already pre-specified in the original protocol, which makes it more relevant than a post-hoc sub-study.
The EXCEL included 1905 patients with left main coronary artery disease and low to intermediate Syntax (≤32) randomized 1:1 to PCI with everolimus eluting stent vs. CABG stratified by the presence of diabetes. Primary end point was a composite of all cause death, stroke and MI at 3 years. Outcomes were examined in 554 diabetic patients vs 1350 non-diabetic.
At 3 years, the combined end point was significantly higher in the diabetic population (20.0% vs. 12.9%; p<0.001). However, in the diabetic cohort, outcomes were similar with PCI and CABG (20.7% vs. 19.3%, respectively; HR: 1.03; CI 95% 0.71 to 1.50; p=0.87), and were also similar (almost identical) in the non-diabetic cohort (12.9% vs. 12.9%, respectively; HR: 0.98; CI 95%: 0.73 to 1.32; p=0.89).
All-cause death occurred in 13.6% of patients receiving PCI vs. 9% in the CABG group (p=0.046). Regardless, diabetes had no significant interaction with any of the end point, be there primary (p=0.82) or secondary, such as death, MI or stroke at 30 days (p=0.61), or death, MI, stroke or ischemia driven revascularization at 3 years (p=0.65).
The EXCEL outcomes, both at 30 days and 3 years, were consistent both for the diabetic and the non-diabetic populations in patients receiving PCI or CABG to treat left main coronary artery disease with low to intermediate syntax score.
Original title: Bypass Surgery or Stenting for Left Main Coronary Artery Disease in Patients with Diabetes.
Reference: Milan Milojevic et al. J Am Coll Cardiol 2019;73:1616–28.
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