STENTYS, with its clever world-first (and indeed only) Self-Apposing® Stent to treat acute myocardial infarction (AMI), has seen final results from the APPOSITION IV study of its new Self-Apposing sirolimus-eluting stent (SES) presented during the Hotline session at the EuroPCR conference in Paris.
We’ve followed the self-apposing stent story for quite a while now, impressed by the notion that the basic design of a stent’s architecture can render it better at avoiding the problems of malapposition and also possessing greater utility in complex anatomies.
The flexible, self expanding design of the Self-Apposing® Stent addresses the stent-sizing dilemma that cardiologists are confronted with when treating heart attack patients or patients with atypical artery anatomy. It takes the shape of the patient’s unique vessel anatomy and apposes to the irregular contours of a blood vessel, in particular after an AMI as the vessel dilates and the clot dissolves. It reduces the risk of malapposition and complications associated with conventional stents in this setting.
The APPOSITION IV study, presented this week at EuroPCR, enrolled 152 patients experiencing ST-elevation myocardial infarction (STEMI) and compared the novel Self-Apposing sirolimus-eluting stent with Medtronic’s Resolute® zotarolimus-eluting stent at two different time points, 4 and 9 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 9 months under OCT), demonstrating stent efficacy and safety.
Stent apposition was statistically better in the STENTYS group than the balloon-expandable group at 4 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 9 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.
“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.”
The STENTYS Self-Apposing Stent has been marketed in Europe since receiving CE Mark in 2010. The STENTYS Sirolimus-eluting stent should receive the CE Mark during the second half of 2014.
Source: Stentys, Inc., Business Wire