Stentys Presents 4-Month Results from the APPOSITION IV Study

October 29, 2013—Stentys (Princeton, NJ) announced that results from the 4-month arm of the APPOSITION IV study of the company's new Self-Apposing sirolimus-eluting stent were presented by coprincipal investigator Robert Jan van Geuns, MD, at the TCT 2013: Transcatheter Cardiovascular Therapeutics conference in San Francisco, California.

The APPOSITION IV trial enrolled 152 patients with ST-segment elevation myocardial infarction (STEMI) in a double-randomized trial to compare the Stentys sirolimus-eluting stent to the study control (Resolute zotarolimus-eluting stent; Medtronic, Inc., Minneapolis, MN) at two time points, 4 and 9 months, evaluating stent apposition and strut coverage under intravascular optical coherence tomography (OCT) imaging.

The company reported that among the 62 patients enrolled in the 4-month group, those treated with a Stentys stent had better apposition than those treated with the control stent (P = .006). The imaging analysis also quantified the number of stent struts covered by tissue, an indication that the endothelial cells lining the artery wall had 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 control stent (P = .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 drug-eluting stent is very good news for our patients,” commented Dr. van Geuns, who is from Erasmus Medical Center in Rotterdam, the Netherlands.

The company advised that the final results of APPOSITION IV are expected to be announced in the second quarter of 2014. Stentys anticipates that the device will receive CE Mark approval and be launched commercially in Europe in the second half of 2014. The full presentation of results will be available on the Stentys website.