Stentys Expands APPOSITION III Enrollment to 1,000 AMI Patients

February 1, 2012—Stentys Inc. (Princeton, NJ) announced completion of expanded enrollment in the APPOSITION III clinical study of its self-apposing stent to treat acute myocardial infarction (AMI).

With an original 500-patient target, the study enrolled a total of 1,000 AMI patients. Final 30-day follow-up results will be presented during the EuroPCR congress to be held in Paris on May 15 to 18, 2012.

The company stated that the Stentys self-apposing stent addresses the problem of stent sizing and malapposition by fitting into the contour of a blood vessel, as its shape and diameter adapt to the anatomic changes of the coronary arteries during the post-AMI phase.

In November 2011, Stentys announced interim data on 600 patients at 30-day follow-up from APPOSITION III. At that time, study investigator Robert Jan van Geuns, MD, commented, “With only 2.4% of patients experiencing a major adverse cardiac event at 30 days in the latest patient cohort compared to rates of over 5% in published landmark trials with conventional stents, these remarkable preliminary clinical results could challenge the existing gold standard of treating AMI patients with balloon-expandable stents.”

In August 2011, Giovanni Amoroso, MD, et al published the results of the APPOSITION I safety and feasibility study in EuroIntervention (2011;7:1–15). By assessing clinical, angiographic, and intravascular outcomes after stent deployment at 3 days and at 6-month follow-up, the investigators concluded that the device is safe and feasible in ST-elevated myocardial infarction patients. They observed that at 3 days, the stent expanded to the same extent as the epicardial vasodilatation and appeared completely apposed to the vessel wall.

Dr. Amoroso commented, “We continue to be very pleased with the results of the Stentys self-apposing stent when treating AMI. During the 6-month follow-up period of the APPOSITION I study, there was no death, no stent thrombosis, or reoccurrence of MI, with revascularization rates comparable to that of conventional stents.”