NOBLE
Trial question
What is the role of PCI in patients with left main coronary artery disease?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
21.0% female
79.0% male
N = 1201
1201 patients (256 female, 945 male).
Inclusion criteria: patients with stable angina, unstable angina, or non-ST elevation MI and left main coronary artery disease.
Key exclusion criteria: STEMI within 24 h, too high risk for CABG or PCI, or expected survival of < 1 year.
Interventions
N=598 PCI (PCI with drug-eluting stents).
N=603 CABG (CABG according to present clinical practice).
Primary outcome
Rate of Kaplan-Meier 5 year estimates of major adverse cardiac or cerebrovascular events
29%
19%
29.0 %
21.8 %
14.5 %
7.3 %
0.0 %
PCI
CABG
Difference exceeding
non-inferiority
margin ✗
Difference exceeding non-inferiority margin in the rate of Kaplan-Meier 5 year estimates of major adverse cardiac or cerebrovascular events (29% vs. 19%; HR 1.48, 95% CI 1.11 to 1.96).
Secondary outcomes
No significant difference in death from any cause (12% vs. 9%; HR 1.07, 95% CI 0.67 to 1.72).
Conclusion
In patients with stable angina, unstable angina, or non-ST elevation MI and left main coronary artery disease, PCI was not noninferior to CABG with respect to the rate of Kaplan-Meier 5 year estimates of major adverse cardiac or cerebrovascular events.
Reference
Makikallio T, Holm NR, Lindsay M et al. Percutaneous coronary angioplasty versus coronary artery bypass grafting in treatment of unprotected left main stenosis (NOBLE): a prospective, randomised, open-label, non-inferiority trial. Lancet. 2016 Dec 3;388(10061):2743-2752.
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