STENTYS announced that three-year follow-up imaging data from the STENTYS arm of the APPOSITION IV clinical study confirms the long-term performance of the sirolimus-eluting Self-Apposing stent. The data will be presented at the Transcatheter Cardiovascular Therapeutics (TCT) Conference in San Francisco, CA. The data were obtained by Quantitative Coronary Angiography (QCA) and Optical Coherence Tomography (OCT) from a group of patients that were examined three years post-treatment for ST-elevation Myocardial Infarction with the STENTYS stent.

The in-stent Late Lumen Loss was 0.08mm (±0.43), while the rate of well-apposed struts was 99.3% and the rate of strut covered by tissue was 99.7%. APPOSITION IV is a prospective, randomized, four-arm, multi-center study designed to compare the STENTYS Sirolimus eluting stent (90 patients) with Medtronic Resolute® (62 patients) in the treatment of ST-elevation Myocardial Infarction. Patients were followed up at either 4 months (63 patients) or 9 months (89 patients).

Stent apposition was statistically better in the STENTYS group than the balloon-expandable group at 4 months, and a greater percentage of STENTYS stents were fully covered by vessel tissue (33% vs 4%, p=0.02), a marker for healing. At 9 months, the STENTYS SES showed no reduction in artery lumen diameter (Late Lumen Loss of 0.04mm ±0.43 under QCA) with a near perfect arterial healing (99% covered struts at 9 months under OCT).