Two-Year Data Presented From MiStent DESSOLVE III Trial
May 23, 2018—Micell Technologies, Inc. announced that a 24-month update on the DESSOLVE III trial of the company's MiStent sirolimus-eluting absorbable-polymer coronary stent system was presented by Prof. William Wijns, MD, in a late-breaking trial session at EuroPCR 2018, held May 21–25 in Paris, France.
According to the company, DESSOLVE III is a prospective, balanced, randomized, controlled, single-blind, multicenter, all-comers study. It is composed of 1,400 patients and enrollment was completed in December 2015. The primary endpoint of the trial was a noninferiority comparison of target lesion failure at 12 months after the procedure for patients treated with the MiStent device versus patients treated with the Xience everolimus-eluting coronary stent system (Abbott Vascular).
The study is being conducted independently by the European Cardiovascular Research Institute of Rotterdam, the Netherlands and is supported by Micell Technologies. Prof. Wijns, along with Prof. Patrick Serruys, MD, and Prof. Robbert J. de Winter, MD, comprise the steering committee that oversaw the DESSOLVE III study design and conduct.
The company noted that key points in the discussion included the continued lower rate of clinically driven target lesion revascularization (TLR) for the MiStent group compared with Xience (4.6% vs 5.4%), as well as a continued lower rate of definite stent thrombosis (0.6% vs 1.0%). Additionally, MiStent maintained numerically lower point estimates versus Xience for any revascularization (12.5% vs 15.5%), target vessel revascularization (6.9% vs 8.5%), and target vessel failure (9.7% vs 10.8%). DESSOLVE III was not powered to show statistical significance between MiStent and Xience.
In the company's announcement, Prof. Wijns commented, "As we expected, there was no evidence of late catch-up in TLR in the MiStent group. Additionally, these DESSOLVE III data reinforce MiStent's outstanding safety profile that we first noted in the DESSOLVE I and II trials, as evidenced by very low probable or definite stent thromboses."
Prof. Wijns continued, "This ultrathin strut stent should become an essential component to a best practices approach to coronary artery disease management, in which advances in both technology and technique are embraced. MiStent is an innovative tool that has the potential to improve long-term clinical outcomes."
MiStent has received European CE Mark approval. It is not approved for sale in the United States. Micell currently is preparing a US Food and Drug Administration investigational device exemption submission for the CRYSTAL study, a prospective, multicenter, randomized trial comparing MiStent with commercially available everolimus-eluting stents.