JACC: Cardiovascular Interventions — Study Demonstrates Superiority of Self-Apposing Stents Over Balloon-Expandable Stents
APPOSITION II randomized study showed 28% malapposition in conventional stents versus 0% in Stentys stents
PRINCETON, N.J. and PARIS – January 3, 2013 - Stentys, a medical technology company commercializing in Europe its Self-Apposing stent to treat acute myocardial infarction (AMI), announced today that results from the foundational APPOSITION II clinical trial were published in the December issue of JACC Cardiovascular Interventions. The manuscript, also available online, is titled, “Self-Expanding Versus Balloon-Expandable Stents in Acute Myocardial Infarction: Results from the APPOSITION II Study”.
The study, conducted between December 2009 and June 2010, compared the accurate implantation of the Stentys Self-Apposing stent vs. a conventional balloon-expandable stent in 80 patients treated for ST-segment elevation myocardial infarction (STEMI). Placement accuracy was measured by high-definition imaging inside the artery (OCT) three days after treatment. The study results showed that 28% of the patients treated with conventional stents had malapposition whereas 0% of the patients with Stentys stents had malapposed stents. This result was statistically significant (p<0.001).
“The results of this study remind us that malapposition, which increases the risk of heart attack recurrence, is very common when treating AMI with conventional stents. They also demonstrate that malapposition can be eliminated with the use of a Stentys stent,” said Robert-Jan van Geuns, MD, PhD of Erasmus Hospital, Rotterdam, the Netherlands, investigator of the study and lead author of the publication.
Stentys received Investigational Device Exemption (IDE) approval from the Food and Drug Administration (FDA) in October 2012 to conduct a pivotal clinical trial in the United States which, if successfully completed, will enable the Company to apply for marketing approval of the Stentys Self-Apposing stent. Patient enrollment into the trial, APPOSITION V, is expected to begin in early 2013. The Company expects to report full results for the ongoing APPOSITION III Study in H1 2013.
About the APPOSITION II Study
APPOSITION II was a prospective, multi-center, two arm randomized trial designed to demonstrate the superiority of the STENTYS Self-Apposing stent over conventional stents in artery apposition in 80 patients suffering from STEMI. The trial’s primary endpoint was stent strut apposition at 3 days under optical coherence tomography (OCT). Secondary endpoints were major adverse cardiac events (MACE) in hospital, at 30 days and at 12 months. At 3 days after implantation, the rate of malapposed stent struts was ten times lower in the Stentys group than in the balloon-expandable group (0.58% vs. 5.46%, p < 0.001). On a per-patient basis, none of the patients in the Stentys group versus 28% in the balloon-expandable group presented = 5% malapposed struts (p < 0.001). At 6 months, MACE rate was statistically equivalent in both groups (2.3% vs. 0%, p = NS).
The Stentys Self-Apposing stent has been marketed in Europe since receiving CE Mark in 2010. It is not approved for marketing in the United States; however, the U.S. Food and Drug Administration recently approved an Investigational Device Exemption (IDE) to conduct a pivotal clinical study that will enroll up to 880 heart attack patients at 50 sites in the U.S. and worldwide.
More information is available at www.stentys.com.