BEST
Trial question
What is the role of everolimus-eluting stents in patients with multivessel coronary artery disease?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
29.0% female
71.0% male
N = 880
880 patients (251 female, 629 male).
Inclusion criteria: patients with multivessel coronary artery disease.
Key exclusion criteria: known hypersensitivity to heparin, aspirin, clopidogrel, everolimus, stainless steel and/or contrast media; severe congestive HF; previous bypass surgery; acute STEMI; abnormal CK; prior history of significant bleeding; contraindication to either CABG or PCI/DES; suspected pregnancy; or left main coronary artery stenosis ≥ 50% diameter.
Interventions
N=438 PCI (with everolimus-eluting stents).
N=442 CABG (standard surgical procedure).
Primary outcome
Death, MI, or target-vessel revascularization
15.3%
10.6%
15.3 %
11.5 %
7.7 %
3.8 %
0.0 %
Percutaneous coronary
intervention
Coronary artery bypass
graft
Difference exceeding
non-inferiority
margin ✗
Difference exceeding non-inferiority margin in death, MI, or target-vessel revascularization (15.3% vs. 10.6%; HR 1.47, 95% CI 1.01 to 2.13).
Secondary outcomes
No significant difference in MI (4.8% vs. 2.7%; HR 1.76, 95% CI 0.87 to 3.58).
Significant increase in death, MI, stroke, or repeat revascularization (19.9% vs. 13.3%; HR 1.54, 95% CI 1.11 to 2.14).
No significant difference in death from any cause (6.6% vs. 5%; HR 1.34, 95% CI 0.77 to 2.34).
Safety outcomes
No significant difference in fatal bleeding.
Significant difference in major bleeding (6.8% vs. 29.9%).
Conclusion
In patients with multivessel coronary artery disease, PCI was not noninferior to CABG with respect to death, MI, or target-vessel revascularization.
Reference
Park SJ, Ahn JM, Kim YH et al. Trial of everolimus-eluting stents or bypass surgery for coronary disease. N Engl J Med. 2015 Mar 26;372(13):1204-12.
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