Biotronik’s Orsiro DES Studied in 5-Year BIO-RESORT Small Vessels Subgroup Analysis

July 6, 2022—Biotronik announced that a BIO-RESORT subgroup analysis of outcomes in small coronary vessels (< 2.5 mm) evaluated the efficacy and safety of three contemporary drug-eluting stents (DESs), including the company’s ultrathin-strut Orsiro DES at 5 years. The results of the analysis were presented by Eline H. Ploumen, MD, at the EuroPCR 2022 conference held May 17-20 in Paris, France.

According to the company, patients with smaller coronary target vessels are usually associated with a higher risk of target lesion revascularization (TLR) after percutaneous coronary intervention (PCI). In this context, the BIO-RESORT subgroup analysis aimed to assess whether thinner struts lead to a lower adverse event risk and better patient outcomes. The randomized trial analyzed the 5-year outcomes of coronary artery disease patients treated with three contemporary DESs of varying strut thickness: ultrathin (Orsiro), very thin (Synergy, Boston Scientific Corporation), and thin (Resolute Integrity, Medtronic).

Biotronik noted that although patients treated with Orsiro DES were more often treated for a complex target lesion than patients with other DESs (71.4% for Orsiro vs 68.7% for Synergy and 63.3% for Resolute Integrity), results showed favorable outcomes for the ultrathin-strut Orsiro DES.

As outlined in the company’s press release, the key 5-year findings included the following:

• Target lesion failure (TLF) for Orsiro DES remained numerically lower (10.5% for Orsiro vs 11.1% for Synergy and 12.6% for Resolute Integrity).
• TLR for Orsiro DES remained numerically lower (4.4% for Orsiro vs 4.7% for Synergy and 6.8%% for Resolute Integrity).
• Definite or probable stent thrombosis rate remained numerically lower for Orsiro DES (1.0% for Orsiro vs 1.7% for Synergy and 2.0% for Resolute Integrity).

Dr. Ploumen, who is from Thoraxcentrum Twente, Medisch Spectrum Twente in Enschede, The Netherlands, commented in Biotronik’s press release, “Although we have not seen a statistically significant difference in 5-year TLF rates, our subgroup analysis shows a trend toward better outcomes with thinner-strut DESs for patients with small vessels. While PCI of small vessel lesions remains challenging, thinner-strut DESs are a good choice for the treatment of these lesions.”

Biotronik stated that the BIO-RESORT noninferiority study included 3,514 all-comer patients and was designed to assess two biodegradable polymer stents against a durable polymer reference device in all-comers patients. At 1-year, noninferiority was established for Orsiro and Synergy against Resolute Integrity DES. The 1-year findings are available on the company’s website. The full-cohort 5-year outcomes from the BIO-RESORT trial were presented at TCT 2021, the 33rd annual Transcatheter Cardiovascular Therapeutics scientific symposium of the Cardiovascular Research Foundation held November 4-6, 2021, online and in Orlando, Florida.