BIO-RESORT Evaluates Biotronik's Orsiro DES With Ultrathin Bioresorable Polymer
May 24, 2018—Biotronik announced that 2-year outcome data from the BIO-RESORT randomized controlled trial were presented by Marlies M. Kok, MD, in a late-breaking clinical trials session at EuropPCR, held May 21–25 in Paris, France, and simultaneously published online in EuroIntervention. Dr. Kok is from Thoraxcentrum Twente, Medisch Spectrum Twente in Enschede, the Netherlands.
The large-scale, three-arm BIO-RESORT trial is composed of a complex all-comers population treated with highly dissimilar contemporary drug-eluting stents (DESs).
According to the company, the 2-year results confirmed the trend seen with the 1-year data, supporting the use of ultrathin bioabsorbable polymer DESs.
At the 2-year follow-up in the BIO-RESORT trial (n = 3,514), all three stents (the Orsiro bioabsorbable-polymer DES, Biotronik; Synergy biodegradable-polymer DES, Boston Scientific Corporation; and Resolute Integrity permanent-polymer DES, Medtronic) showed low target vessel failure rates. The Orsiro DES demonstrated a favorable trend without reaching statistical significance (Orsiro, 6.6%; Synergy, 6.8%; Resolute Integrity, 8.3%).
In the landmark analysis evaluating incremental events between the first and second year of follow-up, patients in the Orsiro arm had significantly lower rates of target lesion failure (TLF) in comparison to the permanent-polymer DES arm (Orsiro, 1.1% vs Resolute Integrity, 2.4%; P = .02) and numerically lower TLF than in the biodegradable-polymer DES arm (Synergy, 1.6% vs Resolute Integrity, 2.4%; P = .22). Additionally, the analysis demonstrated that Orsiro achieved the lowest rate of TLR beyond 1 year across all arms (Orsiro, 0.6% vs Resolute Integrity, 1.5%; P = .04; Synergy, 0.9% vs Resolute Integrity, 1.5%; P = .18).
As reported in Biotronik's announcement, the BIO-RESORT investigators stated, “Very thin-strut biodegradable polymers DES have flexible designs and refined coatings to promote re-endothelialization and reduce the risk of ischemic coronary events." They noted, "Given those signals seen from the landmark analysis, the ultrathin 60-µm bioabsorbable polymer Orsiro DES might reduce the risk of repeat revascularization after the first year of follow-up.”