"Percutaneous Coronary Intervention vs. Coronary Artery Bypass Grafting in Left Main Coronary Artery Disease". The New England Journal of Medicine. 2016. 375:2223-35. PubMed
Links to original sources: Wiki Journal Post Full Journal Article
In patients with obstructive left main coronary artery disease of low or intermediate anatomical complexity, is percutaneous coronary intervention (PCI) with fluoropolymer-based cobalt–chromium everolimus-eluting stents noninferior to coronary-artery bypass grafting (CABG)?
In patients with left main coronary artery disease of low or intermediate anatomical complexity, PCI with everolimus-eluting stents was noninferior to CABG with respect to the composite end point of death, stroke, or myocardial infarction at 3 years.
CABG has been the standard treatment for patients with obstructive left main coronary artery disease. Randomized trials had previously suggested that drug-eluting stents could be a potential alternative to CABG for selected patients with left main disease. The EXCEL trial compared everolimus-eluting stents with CABG in this patient population.
European and U.S. guidelines recommend most patients with left main coronary artery disease undergo CABG. PCI with drug-eluting stents might be an acceptable alternative for selected patients.
- Multicenter, open-label, randomized trial - N=1,905 patients with left main coronary artery disease - PCI with everolimus-eluting stents (n=948) - CABG (n=957) - Synergy between PCI with Taxus and Cardiac Surgery (SYNTAX) score ≤32 - Setting: 126 sites in 17 countries - Enrollment: 2010-2014 - Analysis: Intention-to-treat - Primary outcome: Composite of death from any cause, stroke, or myocardial infarction at 3 years
Inclusion Criteria: - Stenosis of left main coronary artery ≥70% visually estimated, or 50% to <70% with hemodynamic significance determined by noninvasive or invasive testing - Anatomical complexity of coronary artery disease, defined by SYNTAX score ≤32 - CABG or PCI candidacy confirmed by a heart team
Exclusion Criteria: - SYNTAX score >32
Baseline Characteristics: - Well balanced between groups - SYNTAX score: Low (≤22) in 60.5%, intermediate (23-32) in 39.5% - Distal left main bifurcation/trifurcation disease: 80.5% - Two-vessel or three-vessel disease: 51.3%
- PCI goal: Complete revascularization of all ischemic territories - CABG goal: Complete anatomical revascularization of all vessels ≥1.5 mm with angiographic diameter stenosis ≥50%
Primary Outcomes: - Composite of death, stroke, or MI at 3 years occurred in 15.4% (PCI) vs. 14.7% (CABG) (noninferiority margin, 4.2 percentage points; P=0.02 for noninferiority)
- Composite of death, stroke, or MI at 30 days: 4.9% (PCI) vs. 7.9% (CABG) (P<0.001 for noninferiority, P=0.008 for superiority) - Composite of death, stroke, MI, or ischemia-driven revascularization at 3 years: 23.1% (PCI) vs. 19.1% (CABG) (P=0.01 for noninferiority)
Supported by Abbott Vascular
- The EXCEL trial was published in full in The New England Journal of Medicine, with more comprehensive data on the outcomes and trial methodology available in the published article and supplementary materials.