Five-Year Data Presented for Biotronik's Orsiro DES
November 2, 2017—Biotronik announced that the company's Orsiro drug-eluting stent (DES) demonstrated high rates of long-term safety and clinical performance according to 5-year follow-up data presented at TCT 2017, the 29th annual Transcatheter Cardiovascular Therapeutics scientific symposium held October 30 to November 2. The Orsiro DES is an investigational device in the United States, limited by law to investigational use.
Data from the BIOFLOW-II randomized controlled trial were presented in a poster session by study investigator Ton Slagboom, MD. The data showed a target lesion failure (TLF) rate of 10.4% in the Orsiro group and 12.7% in the Xience (Abbott Vascular) study arm at 5 years (P = .4728). No definite or probable stent thrombosis occurred during 5 years of follow-up in the Orsiro group (n = 268). In the Xience group (n = 132), one case (0.7%) of very late definite thrombosis was detected at 5 years.
Data from BIOFLOW-III, a prospective, nonrandomized, open-label, all-comers registry were presented in a poster session by Johannes Waltenberger, MD. Of an initially enrolled population of 1,356 patients, 898 patients consented for long-term follow up. Among these patients, there was a follow-up compliance of 90% at 5 years. The TLF rate of the full cohort was 9.3% at 5 years and definite or probable stent thrombosis occurred in eight cases (0.7%, including two very late stent thromboses).
For both trials, the long-term data demonstrate that the previously observed low TLF rates at 12 months persisted through the 5-year follow-up. Rates of definite and probable stent thrombosis remained low through 5 years. This affirms the safety of the Orsiro stent system in the long term, stated Biotronik.
Dr. Slagboom commented in the company's press release, "In choosing a permanent implant, clinicians must always consider the long-term impact of their choices; with these data, Orsiro joins the limited number of DESs with proven favorable outcomes out to 5 years."
According to Biotronik, the new data presented at TCT 2017 supplements the existing body of evidence supporting the use of the Orsiro DES, with over 32,500 patients enrolled to date in the Orsiro clinical program. This includes the recently reported BIOFLOW-V study data, which showed significantly lower 12-month TLF rates compared to Xience.