Stentys' APPOSITION III Data Demonstrates Low Mortality Rates in STEMI Patients

March 9, 2013—Stentys (Paris, France) announced 1-year results of the APPOSITION III clinical trial at the 62nd Annual Sessions of the American College of Cardiology (ACC) being held in San Francisco on March 9–11. The APPOSITION III trial is a prospective, single-arm, multicenter study composed of 1,000 patients at 50 sites across Europe. It is designed to assess the long-term performance of the Stentys self-apposing stents in routine clinical practice in Europe among patients with ST-elevation myocardial infarction (STEMI).

According to the company's press release, the primary endpoint—rate of major adverse cardiac events (cardiac death, target vessel reinfarction, emergent bypass, or clinically driven target vessel revascularization) at 1 year—was 9.3% with the Stentys device, compared with an average of 11.1% in conventional stents, in a pooled analysis from ACTION Study Group at Pitié-Salpêtrière Hospital in Paris, France. At 1 year, the cardiac death rate was 2% with the Stentys device; rates for conventional stents in other published trials average 3.9%, with the lowest rate being 2.2%, the company stated.

Study investigator Prof. Gilles Montalescot, MD, presented the APPOSITION III data at the ACC conference. Prof. Montalescot, who is head of the Cardiac Care Unit at Pitié-Salpêtrière Hospital, commented in Stentys' press release, “The very low rates of mortality (2%) and target-vessel reinfarction (1.3%) in the APPOSITION III study clearly highlight the excellent safety profile of self-apposing stents.”

The company advised that the Stentys self-apposing stent is designed to address the stent-sizing dilemma by fitting into the contour of a blood vessel, and its shape and diameter adapt as the vessel dilates and the initial clot dissolves during the post-acute myocardial infarction phase, thus reducing the risk of malapposition and complications associated with conventional stents in this setting. The Stentys self-apposing stent received CE Mark approval in 2010. The company will initiate APPOSITION V, its pivotal trial in the United States, during the first half of 2013.