September 23, 2018
SORT-OUT XI the trial comparing Biofreedom and Orsiro stents was released.
The main endpoint was of TLF ( cardiac death, MI, TLR) at 12 months. The trial met the primary endpoint: BioFreedom is non-inferior to Orsiro in TLF at 12 months (5.3% vs 4.0%)
• STENT DELIVERY FAILURE: BioFreedom 2.3% vs Orsiro 2.0%: Strut Thickness again is not a matter in the stent implantation
• TLR Rate BioFreedom 3.5% vs Orsiro 1.3%: Despite TLR rate is higher for Biofreedom it DOES NOT translate to SAFETY ISSUES because in Myocardial Infarction the results are the same and Cardiac Death rate is slightly better to BioFreedom.
• The Cardiac Death is favorable to Biofreedom: BFR 1.2% vs ORS 2.1%
• Stent Thrombosis: 0.7% for both