Micell Technologies announced that the long-term clinical outcomes from the DESSOLVE I and II clinical trials recently were presented at the Cardiovascular Research Technologies (CRT) Conference held in Washington, DC, February 22 – 25. The data presentation, “MiStent SES Clinical Program: DESSOLVE I and II Trials 2-Year Follow-up” was delivered by Alexandra Lansky, director, Interventional Cardiovascular Research and Angiography Core Laboratory Services with the Yale University School of Medicine, New Haven, USA.
According to a press release, the MiStent SES is a thin-strut drug-eluting stent with a bioabsorbable polymer developed to optimise vessel healing in patients with coronary artery disease. The mechanism of action is a unique drug delivery profile with three times longer drug presence versus absorbable polymer. Following elimination of the polymer in 90 days, the anti-proliferative effects of sirolimus continue to be delivered to the artery for up to nine months. Although several current bioabsorbable DES also report drug delivery for up to nine months or more, the MiStent SES’ capability to continue drug delivery in the absence of potential inflammatory-causing polymers is distinctive in this generation of DES with bioabsorbable coatings.
Lansky commented, “MiStent SES is the only product in its class to optimise local drug delivery properties by providing up to nine months of drug presence with only three months for polymer absorption. The rapid elimination of the polymer with the sustained anti-inflammatory and anti-restenotic drug six months beyond the presence of the polymer was designed to allow normal healing while providing effective suppression of neointimal hyperplasia. Detailed imaging by IVUS, OCT and angiography extending from four to 18 months post-stent implantation confirmed desirable bare-metal stent-like healing.”
The DESSOLVE I trial demonstrated minimal progression of late lumen loss between eight and 18 months follow-up, with no target lesion MACE events through two years. The DESSOLVE II randomised trial two-year MACE rate was 6.7% for MiStent and 13.3% for the Endeavor DES control group. There were no probable or definite stent thromboses related to MiStent SES use in either trial through two years. Detailed serial IVUS, angiographic, and OCT imaging through 18 months in DESSOLVE I and angiographic and OCT imaging in conjunction with endothelial function testing in DESSOLVE II demonstrated excellent healing, effective suppression of neointimal hyperplasia with maintenance of normal endothelial function, and a sustained safety profile.