Soon after the EXCEL “Scandal” the NOBLE 5-year Outcomes Come Out: Mere Coincidence?

There is no such thing as coincidence, at least not for the evidence-based medical science. This is what the NOBLE 5-year outcomes, soon to be published in the Lancet, seem to say, in line with the BBC exposé of the EXCEL study.

The NOBLE study randomized patients with left main disease to compare PCI vs CABG.

With a non-inferiority design and carried out in 36 centers across 9 European countries, had the combined end point of major cardiac and cerebrovascular events (MACCE), which include all cause death, non-procedural myocardial infarction, repeat revascularization and stroke. Each one of these points separately were secondary end points. 


Read also: Latest Guidelines “Dropped” After Scandal Over EXCEL Results.


Between 2008 and 2015, 1201 patients were included, 598 undergoing PCI and 603 CABG. 17 patients were lost at follow up and the study was left with 592 patients in each group.

The predefined number of events for sufficient statistical power to assess the primary end point was reached at mean 4.9 years. 

The Kaplan-Meier curves at 5 years showed 28% MACCE rate for PCI and 19% for CABG (HR=1.58; CI 95% 1.24 to 2.01) which exceeds the non-inferiority limit.


Read also: The EXCEL Authors’ Answer to the BBC Investigation.


CABG resulted superior to PCI for the combined primary end point (p=0.0002).

All-cause mortality resulted identical between both strategies (9% for both, p=0.68), but there was a difference in infarction (8% for PCI vs 3% for CABG; p=0.0002) and repeat revascularization rates (17% for PCI vs. 10% for CABG; p=0.0009).

Conclusion

In patients with left main disease, PCI was associated with worse clinical outcomes at 5 years vs. CABG. Mortality resulted similar between both strategies, but PCI presented more spontaneous infarctions and more repeat revascularization.

Original Title: Percutaneous coronary angioplasty versus coronary artery bypass grafting in the treatment of unprotected left main stenosis: updated 5-year outcomes from the randomised, non-inferiority NOBLE trial.

Reference: Niels R Holm et al. Lancet 2019 Dec 23. Online before print.


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