STENTYS: Follow-Up of the APPOSITION IV and OPEN II Clinical Trials at Respectively 3 and 4 Years Confirms the Initial Positive Study Outcomes

PARIS - STENTYS, a medical technology company commercializing the Xposition S Sirolimus-eluting self-apposing coronary stent, today announced that it has reported final follow-up results of two clinical studies featuring STENTYS stents during the annual EuroPCR meeting held in Paris last week.

Oral presentation entitled: “Self-expandable Sirolimus-eluting stent in STEMI: long-term OCT follow-up results from the APPOSITION IV study”, presented by Robert-Jan van Geuns, M.D., Ph.D., Erasmus Medical Center (Rotterdam, the Netherlands).

APPOSITION IV was a prospective, randomized, multi-center study designed to compare the STENTYS Sirolimus-eluting stent (STENTYS SES) with the Medtronic Resolute® stent for the treatment of ST-elevation Myocardial Infarction (STEMI). Presented in 2014, the positive results at 9 months demonstrated the STENTYS SES’ best-in-class efficacy and faster healing compared to balloon-expandable stents. These results mainly contributed to the stent CE marking approval in late 2014.

The APPOSITION IV trial was extended in order to assess the positive long term effects of the STENTYS SES in STEMI patients. Global results at a 3-year follow-up showed that treated vessels remain well patent with stable mean lumen diameter and minimalistic late lumen loss (mean= 0.24mm), and that excellent stent apposition is maintained over time. Stent expansion remained limited, without the formation of any aneurysm.

Oral presentation entitled: “Self-expanding DES in coronary bifurcation lesions at 48 months follow-up: long-term results from the OPEN II trial”, presented by Christoph K. Naber, M.D., Ph.D., Contilia Heart and Vascular Center (Essen, Germany). OPEN II wasthe largest non-randomized study assessing the first-generation of a drug-eluting self-apposing stent (Paclitaxel eluting stent - PES) in bifurcation lesions in more than 200 patients suffering from routine coronary bifurcation stenosis (excluding left main coronary artery).

The 4-year follow-up data showed that the MACE (major adverse cardiac events) rate remains low with a rather flat progression. These results confirm that the STENTYS stent is a true alternative to balloon expandable DES when applying the phased approach technique recommended by the current guidelines.

Christophe Lottin, Chief Executive Officer of STENTYS, comments: “We are delighted that the final follow-up results of our APPOSITION IV and OPEN II studies have met a keen interest of the scientific community during the EuroPCR conference in Paris. Presented data have confirmed the advantages of the self-apposing technology for the treatment of a number of specific clinical conditions in the long run. It also supports our growth strategy based on the Xposition S stent and its targeted indications. We firmly believe that our Xposition stent will be used in a growing number of indications, and its unrivaled technical characteristics will establish it as a benchmark.”

Furthermore, the results of the DESSOLVE III were disclosed directly by MiCell during EuroPCR and are available here.