EXCEL
Trial question
Is PCI with everolimus-eluting stents noninferior to bypass surgery in patients with left main coronary artery disease?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
23.0% female
77.0% male
N = 1905
1905 patients (441 female, 1464 male).
Inclusion criteria: patients with left main coronary artery disease who have low or intermediate anatomical complexity.
Key exclusion criteria: pregnancy, PCI of the left main trunk at any time prior to randomization, CABG at any time prior to randomization, noncardiac comorbidities with left expectancy < 3 years, SYNTAX score ≥ 33,.
Interventions
N=948 PCI (PCI with fluoropolymer-based cobalt-chromium everolimus-eluting stents).
N=957 CABG (standard surgical procedure).
Primary outcome
Death, stroke, or MI at 3 years
15.4%
14.7%
15.4 %
11.6 %
7.7 %
3.9 %
0.0 %
Percutaneous coronary
intervention
Coronary artery bypass
graft
Difference not exceeding
non-inferiority
margin ✓
Difference not exceeding non-inferiority margin in death, stroke, or MI at 3 years (15.4% vs. 14.7%; HR 1, 95% CI 0.79 to 1.26).
Secondary outcomes
Significant decrease in death, stroke, or MI at 30 days (4.9% vs. 7.9%; MD -3.1, 95% CI -4.94 to -1.26).
Safety outcomes
Significant differences in major periprocedural adverse events within 30 days (12.4% vs. 44.0%, p < 0.001).
Conclusion
In patients with left main coronary artery disease who have low or intermediate anatomical complexity, PCI was noninferior to CABG with respect to death, stroke, or MI at 3 years.
Reference
Stone GW, Sabik JF, Serruys PW et al. Everolimus-Eluting Stents or Bypass Surgery for Left Main Coronary Artery Disease. N Engl J Med. 2016 Dec 8;375(23):2223-2235.
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