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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



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