Home > Interventional Cardiology > NOBLE: A Different Story to EXCEL?

NOBLE: A Different Story to EXCEL?

Mäkikallio et al report the result of the NOBLE trial in the Lancet. This is another prospective randomized trial comparing PCI and CABG for left main disease. The results differ from the EXCEL trial. CABG was better than PCI for the composite primary end-point. This also applied to patients with the lowest SYNTAX score. The editorial is available here

Abstract

Background</h2?
Coronary artery bypass grafting (CABG) is the standard treatment for revascularisation in patients with
left main coronary artery disease, but use of percutaneous coronary intervention (PCI) for this indication is increasing.
We aimed to compare PCI and CABG for treatment of left main coronary artery disease.

Methods

In this prospective, randomised, open-label, non-inferiority trial, patients with left main coronary artery
disease were enrolled in 36 centres in northern Europe and randomised 1:1 to treatment with PCI or CABG. Eligible
patients had stable angina pectoris, unstable angina pectoris, or non-ST-elevation myocardial infarction. Exclusion
criteria were ST-elevation myocardial infarction within 24 h, being considered too high risk for CABG or PCI, or
expected survival of less than 1 year. The primary endpoint was major adverse cardiac or cerebrovascular events
(MACCE), a composite of all-cause mortality, non-procedural myocardial infarction, any repeat coronary
revascularisation, and stroke. Non-inferiority of PCI to CABG required the lower end of the 95% CI not to exceed a
hazard ratio (HR) of 1·35 after up to 5 years of follow-up. The intention-to-treat principle was used in the analysis if
not specified otherwise. This trial is registered with ClinicalTrials.gov identifier, number NCT01496651.

Findings

Between Dec 9, 2008, and Jan 21, 2015, 1201 patients were randomly assigned, 598 to PCI and 603 to CABG,
and 592 in each group entered analysis by intention to treat. Kaplan-Meier 5 year estimates of MACCE were 29% for
PCI (121 events) and 19% for CABG (81 events), HR 1·48 (95% CI 1·11–1·96), exceeding the limit for non-inferiority,
and CABG was signifi cantly better than PCI (p=0·0066). As-treated estimates were 28% versus 19% (1·55, 1·18–2·04,
p=0·0015). Comparing PCI with CABG, 5 year estimates were 12% versus 9% (1·07, 0·67–1·72, p=0·77) for all-cause
mortality, 7% versus 2% (2·88, 1·40–5·90, p=0·0040) for non-procedural myocardial infarction, 16% versus 10%
(1·50, 1·04–2·17, p=0·032) for any revascularisation, and 5% versus 2% (2·25, 0·93–5·48, p=0·073) for stroke.

Interpretation

The findings of this study suggest that CABG might be better than PCI for treatment of left main stem coronary artery disease.

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