Author + information
MiStent sirolimus-eluting stent (SES) (Micell Technologies, Durham, NC) has a unique coating technology that allows for continued drug delivery after polymer resorption. Crystalline sirolimus maintains therapeutic drug tissue levels up to 9 months, 3 times longer than the presence of the polymer. The polymer coating is eliminated from a thin-strut (64μm) cobalt chromium stent in 45-60 days with complete tissue absorption within 90 days. Long-term clinical follow-up is important to inform both safety and durability of efficacy. To date, patients from two studies have completed 5-year follow-up.
The DESSOLVE I clinical trial was a multi-center, first-in-human study including 30 MiStent implanted patients. The DESSOLVE II clinical trial was a 2:1 randomized, multi-center study of 184 patients evaluating the MiStent SES compared to the Endeavor control stent for patients with discrete de novo lesions up to 27 mm in length in native coronary arteries. In-stent late lumen loss (LLL) was the primary endpoint in both trials and patients have been followed for clinical events annually for 5 years. All major adverse cardiac events (MACE), defined as all-cause death, myocardial infarction (MI) and target vessel and lesion revascularization (TVR and TLR) as well as stent thrombosis (ARC def/prob) were adjudicated by an independent clinical events committee.
DESSOLVE I observed no target lesion MACE events, and no stent thromboses were observed. In the DESSOLVE II trial, MACE for MiStent and Endeavor were 4.3% versus 6.7% (p=0.49) respectively at nine months, 5.1% versus 8.3% (p=0.51) at 12 months, 6.7% versus 13.3% (p=0.167) at two years, 8.3% versus 15.3% (p=0.197) at three years and 13.3% versus 20.3% (p=0.274) at four years and 15.1% versus 22.0% (p=0.295) at five years. Pooled analysis shows a TLR rate of 2.7% and a MACE rate of 14.1% no definite or probable stent thromboses for MiStent through 5 years of follow-up.
Evaluation of a new DES (MiStent SES) with a distinctive coating to provide continuous drug delivery in absence of polymer reveals a low TLR rate and no probable or definite ST through 5-years follow-up.