"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 • Full text • PDF

Clinical Question

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)?

Bottom Line

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.

Major Points

Guidelines

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.

Design

- 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

Population

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%

Interventions

- PCI goal: Complete revascularization of all ischemic territories
- CABG goal: Complete anatomical revascularization of all vessels ≥1.5 mm with angiographic diameter stenosis ≥50%

Outcomes

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)

Secondary Outcomes:
- 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)

Funding

Supported by Abbott Vascular

Further Reading