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The MiStent sirolimus-eluting stent (SES; Micell Technologies, Durham, NC) has a unique coating composition that allows for continued drug elution after the rapid and complete absorption of polymer. Crystalline sirolimus continues to maintain 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 among patients treated with DES in clinical practice. To date, patients from two studies have completed 4-year follow up.
The DESSOLVE I clinical trial is a multi-center, first-in-human study including 30 MiStent implanted patients. The DESSOLVE II clinical trial, is a 2:1 randomized, multi-center study of 184 patients evaluating the MiStent SES compared with the Endeavor control stent. In the trials, patients with discrete de novo lesions up to 27 mm in length in native coronary arteries were enrolled. In-stent late lumen loss (LLL) was evaluated in both trials and to date, patients have been followed for clinical events annually for 4-years. All major adverse cardiac events (MACE)--defined as all-cause death, myocardial infarction (MI) and target vessel revascularization— (TLR) were adjudicated by an independent clinical events committee.
Follow-up for DESSOLVE I was complete for all available patients at 4-years (29/29). No target lesion MACE events were reported through 4 years, however, 2 non-target vessel MIs and 1 target vessel revascularization, non-TLR, were reported. In the DESSOLVE II trial, MACE for MiStent and Endeavor was 8.3% versus 15.3% (p=0.197), respectively, at 3 years; TLR, and MI for the MiStent SES and Endeavor stent were 2.5% and 3.4% (P=0.665) and 3.3% and 5.1% (P=0.686), respectively, at 3 years. Evaluation of additional 4-year clinical outcomes of the MiStent SES for DESSOLVE II will be presented.
The evaluation of a new DES (MiStent SES) with a distinctive coating to provide continuous drug elution in the absence of polymer reveals sustained clinical results through 4-years follow-up.