2016, Everolimus-Eluting Stents or Bypass Surgery for Left Main Coronary Artery Disease, NEJM
EXCEL Trial Summary
Summarized by Lina Ya’qoub, MD – Cardiovascular disease fellow at Louisiana State University
The Evaluation of XIENCE versus Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization (EXCEL) trial is an international, open-label, non-inferiority, multicenter randomized trial that compared everolimus-eluting stents with CABG in patients with left main coronary artery disease. Inclusion criteria were stenosis of the left main coronary artery of 70% or more, as estimated visually, or stenosis of 50-69% if determined by means of noninvasive or invasive testing to be hemodynamically significant, and a consensus among the members of the heart team regarding eligibility for revascularization with either PCI or CABG. In addition, participants were required to have low-to-intermediate anatomical complexity of coronary artery disease, as defined by a site-determined SYNTAX score, with low score being <=22 and intermediate score being 23-32.
Among the 1905 patients who underwent randomization, 948 were assigned to the PCI group and 957 to the CABG group. Baseline clinical and angiographic characteristics were well balanced between the groups. Among the 948 patients assigned to the PCI group, 942 underwent revascularization; PCI was the first procedure in 935 patients. A mean of 2.4 stents with a mean total stent length of 49.1 mm were implanted per patient; 99.2% of the stents implanted were everolimus-eluting stents. Among the 957 patients assigned to the CABG group, 940 underwent revascularization; CABG was the first procedure in 923 patients. A mean of 2.6 grafts per patient were placed; an internal thoracic artery graft was used in 98.8% of the patients.
The median duration of follow-up was 3.0 years (interquartile range, 2.4 to 3.0) in both groups. The primary composite end-point event of death, stroke, or myocardial infarction at 3 years occurred in 15.4% of the patients in the PCI group and in 14.7% of the patients in the CABG group (difference, 0.7 percentage points; upper 97.5% confidence limit, 4.0 percentage points; P=0.02 for noninferiority; hazard ratio, 1.00; 95% confidence interval [CI], 0.79 to 1.26; P=0.98 for superiority).
At 30 days, the composite end-point event of death, stroke, or myocardial infarction had occurred in 4.9% of the patients in the PCI group and in 7.9% of the patients in the CABG group (difference, −3.1 percentage points; upper 95.0% confidence limit, −1.2 percentage points; P<0.001 for noninferiority).At 3 years, the composite end-point event of death, stroke, myocardial infarction, or ischemia-driven revascularization had occurred in 23.1% of the patients in the PCI group and in 19.1% of the patients in the CABG group (difference, 4.0 percentage points; upper 95% confidence limit, 7.2 percentage points; P=0.01 for noninferiority).
Several studies have shown that outcome and safety of left main disease percutaneous coronary intervention (PCI) is similar to caronary artery bypass graft (CABG) in selected patients. The EXCEL trial aim was to assess major adverse cardiac events (death, stroke, MI) for PCI versus CABG over 3 years in patients with low-intermediate syntax scores. This randomized controlled trial proved that PCI was non-inferior to CABG in this population.