One-year interim results from APPOSITION III study of Self-Apposing stent to be presented at TCT


Stentys has announced that one-year interim results from the APPOSITION III study will be presented during the Transcatheter Cardiovascular Therapeutics (TCT) conference (Miami, USA, 22–26 October).

Harald Mudra, Klinikum Neuperlach, Munich, Germany, will present the results during the morning spotlight session “Primary PCI for STEMI: Drugs, Devices, and Technique Controversies” on Thursday, 25 October.

APPOSITION III is a prospective, single-arm, multicentre (50 hospitals across Europe) post-market trial to assess the long term performance of the Stentys Self-Apposing stent in routine clinical practice in 1,000 patients suffering from ST-Elevation Myocardial infarction (STEMI). The trial’s primary endpoint is major adverse cardiac events (MACE) at 12 months. MACE is defined as cardiac death, target vessel re-MI, emergent by-pass, or clinically-driven target vessel revascularisation by percutaneous or surgical methods at 12 months. The trial’s secondary endpoints are MACE at 30 days and 24 months post-procedure. The study completed enrolment in January 2012. The MACE rate at 30 days was 3.5% for the full study population and 2.5% when post-dilation was performed. Mortality rate at 30 days was 1.2% for the full study population.

Stentys also announced that it will be hosting a satellite symposium during TCT that will provide an overview of the Stentys Self-Apposing Stent clinical results to date and the proposed US investigational device exemption trial in STEMI.

The symposium, chaired by Maurice Buchbinder, Foundation of Cardiovascular Medicine, San Diego, USA, is being held Wednesday, 24 October.

The satellite symposium will feature:

  • “Better stent sizing leads to better outcomes: The Self-Apposing Stent technology”, presented by Buchbinder.
  • “Real-world use in 1000 STEMI patients: APPOSITION III one-year interim results”, presented by Mudra.
  • “Routine clinical practice and experience with a Self-Apposing Stent”, presented by Robert-Jan van Geuns, Erasmus MC, Rotterdam, The Netherlands.
  •  “Stentys’ proposed randomised IDE trial in STEMI, the APPOSITION V study in the United States and worldwide”, presented by Roxana Mehran, Mount Sinai Hospital, New York.