Two-Year Data Published for DESSOLVE Trials of Micell's MiStent

October 5, 2015—Two-year outcomes from the DESSOLVE I and DESSOLVE II trials of the bioabsorbable polymer-coated, sirolimus-eluting coronary MiStent (Micell Technologies, Inc.) were published by William Wijns, MD, et al online ahead of print in EuroIntervention. 

DESSOLVE I is the first-in-human clinical assessment of safety and efficacy of the MiStent and included 30 patients with de novo lesions in coronary arteries ranging in diameter from 2.5 to 3.5 mm and amenable to treatment with a maximum 23-mm-length stent. Patients were enrolled across five study centers in New Zealand, Australia, and Belgium.

DESSOLVE II is a randomized study of the safety and efficacy of the MiStent sirolimus-eluting stent compared to a zotarolimus-eluting stent (Endeavor Sprint, Medtronic plc). The DESSOLVE II study completed enrollment of 184 patients in July 2011.

In EuroIntervention, the investigators reported the rates of major adverse cardiac events (MACE), target lesion failure (TLF), target vessel failure (TVF), and stent thrombosis at 2-year follow-up. 

At 2 years in DESSOLVE I, the MiStent (n = 29) had a 3.4% MACE rate with no TLF or TVF. 

At 2 years in DESSOLVE II, the MiStent demonstrated a 6.7% MACE rate (8/120) compared to 13.3% MACE rate (8/60) for Endeavor (P = .167). The TLF rate was 5% for both MiStent and Endeavor (P = 1.00). The TVF rate was 5% for MiStent versus 11.7% for Endeavor (P = .129). No probable or definite stent thrombosis was reported with the MiStent up to 2 years. The median duration of dual-antiplatelet therapy in DESSOLVE I and II was 364 and 366 days, respectively.

The MiStent demonstrated good long-term safety and effectiveness with low 2-year MACE, TLF, and TVF rates, concluded the investigators in EuroIntervention.

In September 2014, Micell Technologies announced that 3-year clinical results from the DESSOLVE I and DESSOLVE II were presented by John Ormiston, MD, at TCT 2014, the 26th Transcatheter Cardiovascular Therapeutics conference in Washington, DC. Dr. Ormiston, who serves as a principal investigator in the DESSOLVE studies, is an interventional cardiologist with the Mercy Angiography Unit in Auckland, New Zealand. Dr. Wijns, who serves as coprincipal investigator for DESSOLVE I, is with the Cardiovascular Center in Aalst, Belgium.