Stentys Presents Final Results from the APPOSITION IV Study

May 20, 2014—Stentys announced the presentation of final results from the APPOSITION IV study at the EuroPCR 2014 conference being held May 20–23 in Paris, France. APPOSITION IV is an evaluation of the new Stentys Self-Apposing sirolimus-eluting stent (SES) to treat acute myocardial infarction.

According to Stentys, APPOSITION IV enrolled 152 patients experiencing ST-segment elevation myocardial infarction (STEMI) and compared the Stentys SES to the Resolute zotarolimus-eluting stent (Medtronic, Inc.). In the prospective, randomized, four-arm, multicenter study, 90 patients received the Stentys device and 62 patients received the Medtronic Resolute device. Patients were followed up at either 4 months (63 patients) or 9 months (89 patients). The endpoints are strut apposition and coverage under optical coherence tomography (OCT) at 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 OCT to quantify the number of stent struts apposed and covered by tissue, indicating that the endothelial cells lining the artery wall have grown around the stent and that the vessel has healed.

The company reported that at 4 months, stent apposition was statistically better in the Stentys group than in the balloon-expandable group (0.07% malapposed struts vs 1.16%; P = .005), and a greater percentage of Stentys stents were fully covered (33% vs 4%; P = .02).

At 9 months, the Stentys SES demonstrated efficacy and safety with no reduction in artery lumen diameter (late lumen loss of 0.04 mm ± 0.43, under QCA) with near-perfect arterial healing (99% covered struts, under OCT). Strut apposition and coverage were similar in both groups. The results confirm that arteries with the Stentys SES healed faster than arteries with the balloon-expandable drug-eluting stent.

The trial’s coprincipal investigator Robert-Jan van Geuns, MD, commented in the company’s press release, “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. An efficacious drug with a perfectly apposed stent over time ensures fast healing and an open vessel in the long run.” Dr. van Geuns is from Erasmus Medical Center in Rotterdam, the Netherlands.

The company advised that the Stentys Self-Apposing SES should receive European CE Mark approval during the second half of 2014. The nondrug-eluting Stentys Self-Apposing stent has been marketed in Europe since receiving CE Mark approval in 2010.