Stentys, a medical technology company, has presented final results from the APPOSITION IV study of its new Self-Apposing sirolimus-eluting stent (SES) during the Hotline session at the EuroPCR conference in Paris.
APPOSITION IV enrolled 152 patients experiencing ST-elevation myocardial infarction (STEMI) and was the first clinical trial to evaluate the novel Self-Apposing sirolimus-eluting stent, which was compared to Medtronic’s Resolute zotarolimus-eluting stent at two different time points, four and nine months.
The evaluation was based on two imaging modalities: Quantitative Coronary Angiography (QCA) to measure the difference in artery diameters between implantation and follow-up, and Optical Coherence Tomography (OCT) to quantify the number of stent struts apposed and ‘covered’ by tissue, an indication that the endothelial cells lining the artery wall have grown around the stent and that the vessel has healed.
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 nine months under OCT), demonstrating stent efficacy and safety.
Stent apposition was statistically better in the STENTYS group than the balloon-expandable group at four months (0.07% malapposed struts vs 1.16%, p=0.005), and a greater percentage of STENTYS stents were fully covered (33% vs 4%, p=0.02). At nine months, strut apposition and coverage were similar in both groups. The results confirm that arteries with STENTYS SES healed faster than with balloon-expandable drug-eluting stents.
Stentys CEO and co-founder Gonzague Issenmann said that with these study results, the company’s sirolimus-eluting stent could receive CE Mark as soon as the second half of 2014.