Three Year Clinical Outcomes of a Unique Sirolimus-Eluting Stent with Fully Absorbable Polymer Coating: Long-term Results from the DESSOLVE I and the DESSOLVE II Clinical Trials

John A. Ormiston, Alexandra Lansky, Dennis Donohoe, Charlene Knape, Mathias Vrolix, Stefan Verheye, Danny F. Schoors, William C. Wijns

Research output: Contribution to journalMeeting abstract (Journal)

Abstract

Background: Unlike any other current bioabsorbable drug-eluting stent, the MiStent 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 (64mm) cobalt chromium stent in 45-60 days with complete tissue absorption within 90 days. Long-term clinical follow-up is important to confirm the continued safety of patients treated with DES in clinical practice. To date, patients from two studies have completed 3 year follow-up.
Methods: The DESSOLVE I clinical trial is a first-in-human study at 5 sites of 30
MiStent implanted patients; the DESSOLVE II clinical trial, is a 2:1 randomized study of 184 patients conducted at 26 sites in evaluating the MiStent SES as compared to the control stent, the Endeavor Sprint. 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 3-years. All MACE events, defined as all death, Q and non-Q wave myocardial infarction and all target vessel revascularization were adjudicated by an independent clinical events committee.
Results: Follow-up for DESSOLVE I was complete for all available patients at 3-
years (29/29). No target lesion MACE events were reported through 3 years, however, 2 non-target vessel MIs were reported. In the DESSOLVE II trial, MACE for MiStent and Endeavor was 4.3% versus 6.7% (p¼0.49) respectively at 9 months, 5.1% versus 8.3% (p¼0.51) at 12 months and 6.7% versus 13.3% (p¼0.167) at 2 years. Evaluation of additional 3-year clinical outcomes of the MiStent SES for DESSOLVE II will be presented.
Conclusions: 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 3-years follow-up.
Original languageEnglish
Pages (from-to)B174-B174
JournalJournal of the American College of Cardiology
Volume64
Issue number11
Publication statusPublished - 16 Sep 2014
EventTCT - Washington DC, United States
Duration: 13 Sep 201417 Sep 2014

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