NOBLE

Nordic-Baltic-British Left Main Revascularisation Study

Patient / Population Intervention / Exposure Comparison Outcome

In 1,201 patients with unprotected left main coronary disease, PCI with drug-eluting stents increased 5-year death, MI, repeat revascularisation, or stroke compared with CABG.

1,201

Design

Multicentre open-label RCT, non-inferiority

Endpoint

MACCE (all-cause death, non-procedural MI, repeat revascularisation, or stroke)

Relevance

Result5-year MACCE PCI 29% vs CABG 19% (HR 1.48, 95% CI 1.11-1.96); non-inferiority not met and CABG superior. All-cause mortality similar (12% vs 9%).

Mäkikallio T, et al. Lancet. 2016;388(10061):2743-52. 10.1016/S0140-6736(16)32052-9

Discussion & critique

Its MACCE endpoint excluded periprocedural MI but counted all repeat revascularisation, opposite to EXCEL's design, explaining why the two contemporaneous left-main trials reached opposite conclusions.