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SORT OUT IX Data Update: BioFreedom Does Not Meet Non-inferiority Criteria Compared to Orsiro Drug-Eluting Stent

Trial Investigators Find Statistical Calculation Errors After Presenting Results at TCT Congress

Following a statistical calculation error, the outcomes of SORT-OUT IX1 have recently been corrected, resulting in a change to the trial’s primary endpoint. The revised data analysis demonstrates that compared to BIOTRONIK’s Orsiroa drug-eluting stent (DES), Biosensors’ BioFreedomb stent does not meet non-inferiority criteria.

The SORT OUT IX trial included 3,151 all-comer patients randomized to receive either the thick-strut stainless steel BioFreedom stent or the ultrathin strut bioresorbable polymer Orsiro DES. In contrast to what was reported at the TCT Congress in September 2018 and in a previous press release, corrected statistical data shows that BioFreedom is inferior to Orsiro in the primary endpoint of target lesion failure at one year follow-up (5.2% vs 4.0% p for non-inferiority=0.123). Furthermore, BioFreedom demonstrated significantly lower efficacy than Orsiro (target lesion revascularization: 3.5% vs 1.3%, p<0.0001). The corrected trial presentation slides are available online.

“We had initially said the BioFreedom stent was not worse than the Orsiro stent,” explained co-principal investigator Dr. Lisette Okkels Jensen, Odense University Hospital, Odense, Denmark, to TCTMD. “Now, when we found a non-significant P-value, the overall message is that it didn’t meet the criteria for non-inferiority.”2

The SORT-OUT IX investigators discovered the mistake in the statistical calculations while they were preparing the data for submission to a medical journal.


1 Okkels Jensen L, SORT OUT IX: A Randomized Trial Comparing a Polymer-Free Coronary Drug-Eluting Stent With an Ultra-Thin Strut Bioresorbable Polymer-Based Drug-Eluting Stent in an All-Comers Patient Population, Presented at TCT, San Diego USA, September 2018.

2 https://www.tctmd.com/news/sort-out-ix-statistical-mix-turns-trials-primary-endpoint-around



BIOTRONIK is a leading medical device company that has been developing trusted and innovative cardiovascular and endovascular solutions for more than 50 years. Driven by a purpose to perfectly match technology with the human body, BIOTRONIK innovations deliver care that saves and improves the lives of millions diagnosed with heart and blood vessel diseases every year. BIOTRONIK is headquartered in Berlin, Germany, and represented in over 100 countries.