Five-Year DESSOLVE Data Published for Micell's MiStent
January 9, 2018—Micell Technologies, Inc. announced that a report of the 5-year data from the DESSOLVE I and DESSOLVE II trials by Professor William Wijn, MD, et al has been accepted for publication in EuroIntervention and is available online. The goal of the two trials was to evaluate long-term clinical outcomes for the company's crystalline MiStent sirolimus-eluting coronary stent system with a fully bioabsorbable polymer coating.
In November 2016, the company announced that the 5-year clinical safety and efficacy results from DESSOLVE I and DESSOLVE II were presented by David E. Kandzari, MD, at TCT 2016, the 28th annual Transcatheter Cardiovascular Therapeutics scientific symposium in Washington, DC. In December 2017, Micell announced that 12-month results from the DESSOLVE III clinical trial of the MiStent were published by Professor Robbert J. de Winter, MD, et al online ahead of print in The Lancet.
According to Micell, among the 148 MiStent patients who completed DESSOLVE I or DESSOLVE II, there were zero definite or probable stent thromboses observed through 5-year follow-up, demonstrating long-term safety. The combined study results demonstrated the device's long-term effectiveness with a 5-year clinically driven target lesion revascularization (TLR) of 2.7%.
DESSOLVE I was a single-arm, first-in-human trial. DESSOLVE II was a 2:1 randomized trial comparing MiStent and the Endeavor Sprint drug-eluting stent (Medtronic). Both studies included patients with symptomatic ischemic heart disease due to de novo lesions in native coronary arteries with > 50% diameter stenosis.
In the company's announcement, Prof. Wijns commented, "We achieved greater than 95% 5-year follow-up for all DESSOLVE I and II patients. Across both studies, MiStent showed low rates of TLR, along with no definite or probable stent thrombosis."
MiStent has received European CE Mark approval. It is not approved for sale in the United States, advised the company.