Micell Technologies announced on 8 October that a peer-reviewed article discussing imaging and clinical results of the DESSOLVE I trial of its MiStent Sirolimus Eluting Absorbable Polymer Coronary Stent System (MiStent SES) was accepted for publication on the JACC: Cardiovascular Interventions website.
The paper, “First-in-human evaluation of a bioabsorbable polymer–coated sirolimus-eluting stent: imaging and clinical results of the DESSOLVE I trial (DES with sirolimus and a bioabsorbable polymer for the treatment of patients with de novo lesion in the native coronary arteries)”, is planned to also appear in the October 2013 issue of JACC: Cardiovascular Interventions.
The article concludes that, at 18 months follow-up, the MiStent SES—an absorbable polymer-coated, cobalt chromium, sirolimus-eluting stent—was associated with a low and stable in-stent late lumen loss, complete strut coverage, and no stent thrombosis. The authors of this paper included co-principal investigators for the DESSOLVE I trial, William Wijns, Cardiovascular Center, Aalst, Belgium, and John Ormiston, Mercy Angiography Unit, Auckland, New Zealand.
Data included in this paper also will be the subject of a presentation by John Ormiston at the 24th Annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium which will be held in San Francisco, USA, 27 October–1 November.
About the MiStent SES
Results of animal studies have determined that the coating is cleared from the stent in 45 to 60 days leaving a bare metal stent and the polymer is completely absorbed into the surrounding tissue within 90 days to promote long-term patency and compatibility with the artery.
Micell was granted CE mark approval for MiStent SES in June 2013, but is not approved in the USA or any other countries. A two-year follow-up of DESSOLVE I and II clinical studies subjects was completed in 2013, and they currently are undergoing long-term follow-up.
About DESSOLVE I and DESSOLVE II studies
The DESSOLVE I trial, the first clinical assessment of safety and efficacy of the investigational MiStent SES, treated thirty patients with de novo lesions in coronary arteries ranging in diameter from 2.5–3.5mm and amenable to treatment with a maximum 23mm length stent. Subjects were enrolled across five study centres in New Zealand, Australia and Belgium. Three independent subgroups of 10 patients each were evaluated using angiography, IVUS and OCT at three time points: four, six and eight months. The primary efficacy endpoint was in-stent late lumen loss. Safety was assessed by incidence of major adverse cardiac events and presence of strut coverage with tissue within the treated artery at each time point.
The DESSOLVE II CE mark trial is a randomised, multi-centre study of patients with documented stable or unstable angina pectoris. The primary endpoint is superiority of the MiStent SES in minimising in-stent late lumen loss at nine months, compared to Medtronic’s Endeavor Sprint DES, as measured by an independent angiography core laboratory in de novo coronary lesions in vessels ranging in diameter from 2.5–3.5 mm and amenable to treatment with a maximum 30mm length stent. The DESSOLVE II study completed enrolment of 184 patients in July 2011. Data analysis confirms that DESSOLVE II met all study objectives, demonstrated a competitive in-stent late lumen loss, and achieved strong signal of safety.