November 3, 2017 — Biotronik's Orsiro drug-eluting stent (DES) demonstrated high long-term safety and clinical performance according to 60-month follow-up data presented during the 2017 Transcatheter Cardiovascular Therapeutics Annual Conference (TCT 2017), Oct. 29-Nov. 2 in Denver.
Data from the BIOFLOW-II randomized controlled trial was presented in a poster session by Ton Slagboom, M.D., Onze Lieve Vrouwe Gasthuis, Amsterdam, Netherlands, showing a target leisure failure (TLF) rate of 10.4 percent in the Orsiro group and 12.7 percent in the Xience study arm at 60 months (p=0.4728). No definite or probable stent thrombosis occurred during 60 months of follow-up in the Orsiro group (n=268). In the Xience group (n=132), one case of very late definite thrombosis was detected (0.7 percent) at five years.
In addition, data from BIOFLOW-III, a prospective, non-randomized, open-label, all-comers registry was presented in a poster session by Johannes Waltenberger, M.D., professor of cardiology and angiology at University Hospital Münster, Germany. 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 percent at 60 months. The TLF rate of the full cohort was 9.3 percent at 60 months and definite or probable stent thrombosis occurred in eight cases (0.7 percent, including two very late stent thromboses).
Long-term data for both trials demonstrate that the previously observed low TLF rates at 12 months persisted through the 60-month follow-up. Rates of definite and probable stent thrombosis remained low through 60 months, affirming the safety of the Orsiro stent system in the long term.
"In choosing a permanent implant, clinicians must always consider the long-term impact of their choices; with this data Orsiro joins the limited number of DES with proven favorable outcomes out to five years," commented Slagboom, an investigator in the BIOFLOW-II trial.
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.
Read the February 2019 article FDA Clears Biotronik Orsiro Stent That Outperforms Xience
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