BioFreedom Stent May Not Measure Up to Orsiro After All

— Conclusion of non-inferiority withdrawn after statistical error is corrected

by Nicole Lou, Staff Writer, �鶹��ý November 8, 2018

After discovering a statistical error in their initial analysis, leaders of the SORT OUT IX trial said this week that the BioFreedom stent may not be non-inferior to competitor Orsiro after all.

At the Transcatheter Cardiovascular Therapeutics meeting in September, investigators reported that the polymer-free BioFreedom stent was non-inferior to the much thinner Orsiro stent for the trial's primary endpoint of target lesion failure at 12 months (5.2% BioFreedom versus 4.0% Orsiro).

However, the P-value for non-inferiority was actually 0.123, not 0.01 as previously reported at the conference and by �鶹��ý.

The results flipped because the researchers mistakenly used a noninferiority margin that was too large during their analysis. The error came to light while the group was preparing SORT OUT IX for publication in a journal, as in breaking the story.

After correcting the data, stent thrombosis rates remained no different between groups (1.0% versus 1.1%, P=0.73) and the BioFreedom was still associated with more target lesion revascularization (3.5% versus 1.3%, P<0.0001)

Corrected slides have now been .

Nicole Lou is a reporter for �鶹��ý, where she covers cardiology news and other developments in medicine.