May 23, 2014 — Stentys 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 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 nine 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 percent 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 percent malapposed struts vs 1.16 percent, p=0.005), and a greater percentage of Stentys stents were fully covered (33 percent vs. 4 percent, 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 (DES).
"In the APPOSITION IV trial, we found that the addition of sirolimus elution to the Stentys platform brings the best of both worlds together for heart attack patients,” said Robert-Jan van Geuns, M.D., Ph.D., Erasmus Medical Center, Rotterdam, the Netherlands, co-principal investigator. “An efficacious drug with a perfectly apposed stent over time ensures fast healing and an open vessel in the long run."
"We are thrilled with the results and very grateful to the APPOSITION IV study investigators for further advancing the knowledge and clinical experience of the self-apposing technology," said Gonzague Issenmann, CEO and co-founder of Stentys. "With these study results, our sirolimus-eluting stent could receive CE mark as soon as the second half of this year."
For more information: www.stentys.com