BIOFLOW-V
Comparison of Ultrathin strut Orsiro® Bioresorbable Polymer DES to Xience* Durable Polymer DES at 36 Months
BIOFLOW-V: FDA pivotal trial at 36 months
Conclusions
Significant differences in TLF observed at year 1 and 2 were maintained and further increased at year 3 (8.6% vs. 14.4%, p = 0.003), driven by significant differences in TV-MI (5.5% vs. 10.1%, p = 0.004) and Ischemia-driven TLR (3.4% vs. 6.9%, p = 0.008) that favor Orsiro over Xience.
• 40% lower TLF rate (p = 0.003)
• 46% lower TV-MI rate (p = 0.004)
• 52% lower ischemia-driven TLR rate (p = 0.008)
• 90% lower late/very late definite/probable ST rate (p = 0.018)