4-month results of APPOSITION IV Study presented at TCT 2013

PRINCETON, N.J. and PARIS.  STENTYS, a medical technology company commercializing in Europe the world's first and only Self-Apposing® Stent to treat acute myocardial infarction (AMI), announced today results from the 4-month arm of the APPOSITION IV study of its new Self-Apposing Sirolimus-eluting stent during the TCT (Transcatheter Cardiovascular Therapeutics) conference.  

The APPOSITION IV trial enrolled 152 patients suffering from ST-elevation Myocardial Infarction (STEMI) in a double-randomized trial to compare the STENTYS Sirolimus-eluting stent to Medtronic's Resolute® zotarolimus-eluting stent at two different time points, 4 and 9 months, evaluating stent apposition and strut coverage under intra-vascular OCT imaging (optical coherence tomography).

Among the 62 patients enrolled in the 4-month group, those treated with a STENTYS stent had better apposition than the control stent (p=0.006). The imaging analysis also quantified the number of stent struts "covered" by tissue, an indication that the endothelium cells lining the artery wall have grown around the stent and that the vessel has healed. At 4 months, 32% of the STENTYS stents had all struts already covered compared to 4% for the Resolute (p=0.03). 

"Long-term malapposition and partial strut coverage of drug-eluting stents have been associated with late stent thrombosis, so the early healing of vessels treated with STENTYS DES is very good news for our patients," said Dr. Robert Jan van Geuns, M.D., Ph.D., Erasmus Medical Center (Rotterdam, the Netherlands), co-Principal Investigator of the study, who presented the data.

"These data provide further evidence of the significant benefits that the Self-Apposing technology can bring to heart attack patients," said Gonzague Issenmann, CEO and co-founder of STENTYS. "The Self-Apposing Sirolimus-eluting stent remains on track for CE Marking and commercial launch in the second half of 2014."

The full presentation of results will be available on the STENTYS website.

About the STENTYS Self-Apposing® Stent

The STENTYS Self-Apposing® Stent addresses the stent-sizing dilemma that cardiologists are confronted with when treating heart attack patients or patients with atypical artery anatomy. Its flexible, self expanding design 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 STENTYS Self-Apposing Stent has been marketed in Europe since receiving CE Mark in 2010. The STENTYS Sirolimus-eluting stent is expected to receive CE Mark in H2 2014.

About the APPOSITION IV Study

APPOSITION IV is a prospective, randomized, two-arm, multi-center study designed to compare the apposition of the STENTYS Sirolimus eluting stent with Medtronic Resolute® in 150 patients suffering from ST-elevation Myocardial Infarction. Patients will be followed up at either 4 or 9 months (double randomization). The powered primary endpoint is strut apposition at 9 months under OCT. The secondary endpoints are strut apposition at 4 months under OCT and strut coverage at 4 and 9 months. The final results are expected to be announced in Q2 2014. 

Source: STENTYS