Enrollment Completed in DESSOLVE III Trial of the MiStent SES

December 9, 2015—Stentys announced the completion of patient enrollment in DESSOLVE III randomized clinical trial evaluating the company’s MiStent SES, a sirolimus-eluting absorbable polymer coronary stent system, compared to Abbott Vascular’s Xience everolimus-eluting stent. The balloon-expandable MiStent SES device is designed to improve long-term clinical outcome of patients treated with conventional stents. 

DESSOLVE III is a prospective, balanced, randomized, controlled, single-blind, multicenter study comparing clinical outcomes between MiStent SES and Xience in a real-world, all-comers patient population of 1,400 patients in 20 hospitals in Europe. Micell Technologies, Inc. developed and manufactures the MiStent SES. The device is marketed in the European Union through Stentys.

According to Stentys, patients in the trial presented with symptomatic coronary artery disease, including chronic stable angina, silent ischemia, or acute coronary syndrome, and qualified for percutaneous coronary interventions. The primary endpoint is a noninferiority comparison of target lesion failure of the MiStent SES group versus the Xience group at 12 months postprocedure. 

MiStent SES is composed of a cobalt chromium alloy with very thin 64-μm struts. The bioabsorbable coating of MiStent SES disappears within 3 months of implantation to promote fast vessel healing. The sirolimus elution is precisely and consistently controlled up to 9 months after implantation, thereby inhibiting vessel renarrowing.

According to the company, MiStent’s crystalline sirolimus technology, in which thousands of microscopic drug crystals slowly dissolve in the surrounding tissue after absorption of the polymer carrier, allows for a gradual, linear, and much longer elution of sirolimus than with other competitive stents, thereby reducing vessel overscarring. With a 2.0% target lesion revascularization rate at 3-year follow-up in previous clinical trials, MiStent SES demonstrated superiority to Xience in a retrospective propensity analysis that was presented by Alexandra Lansky, MD, at the EuroPCR 2015 conference last May in Paris, France.

In February 2015, Stentys introduced the MiStent in Western Europe via a controlled launch, followed by a full commercial launch in the second half of 2015 in selected countries within Europe, the Middle East, Southeast Asia, and Latin America. MiStent SES received European CE Mark approval in June 2013.