A 24-month update on the DESSOLVE III trial of the MiStent^® Sirolimus Eluting Absorbable Polymer Coronary Stent System was presented this week at EuroPCR 2018, an international congress of interventional cardiovascular medicine researchers and clinicians held in Paris, France.

Data were presented by William Wijns, M.D., Ph.D., of The Lambe Institute for Translational Medicine at the National University of Ireland and Co-Director of EuroPCR, in a late-breaking trial update session on drug-eluting stents (DES). Key points in the discussion included the continued lower rate of clinically-driven target lesion revascularization (CD-TLR) for the MiStent group compared to Xience, as well as a continued lower rate of definite stent thrombosis.

Additionally, this trial is unique in that MiStent has maintained numerically lower point estimates versus Xience for any revascularization, target vessel revascularization (TVR), and target vessel failure (TVF). DESSOLVE III was not powered to show statistical significance between MiStent and Xience.

“As we expected, there was no evidence of late catch-up in TLR in the MiStent group,” noted Dr. Wijns. “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.”

Dr. Wijns continued, “This ultra-thin 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.”

Two additional presentations featuring MiStent clinical data are planned for EuroPCR:

• Professor Robbert J. de Winter, M.D., Ph.D., Department of Cardiology, Academic Medical Center, Amsterdam, The Netherlands will present a MiStent case study.
• Professor Krzysztof Milewski, M.D., Ph.D., General Director, Center for Research and Development for the American Heart of Poland S.A., published the most recent update from the DESSOLVE III optical coherence tomography (OCT) sub-study in a poster presentation.

Commenting on the growing body of clinical evidence in support of MiStent, Dennis Donohoe, M.D., Micell’s chief medical advisor, said, “In the DESSOLVE III data, we are pleased to observe the same overall progression of TLR over time that was noted in earlier studies, despite the significant challenges represented by patients in the DESSOLVE III all-comers population.”

He also noted, “The clinical results we are seeing in these studies validate the hypotheses generated from Tzafriri et. al. recently published in the Journal of Controlled Release (link to article).  This research found that crystalline sirolimus combined with MiStent’s proprietary coating technology could lead to optimized drug delivery and enhanced clinical results.”

About MiStent^®

MiStent, a coronary stent with a sirolimus-eluting absorbable polymer coating, is designed to optimize clinical performance and healing in patients with coronary artery disease. The rapidly absorbable coating of MiStent, comprising crystalline drug and an absorbable polymer, is intended to precisely and consistently provide extended local drug delivery and limit the duration of polymer exposure. These characteristics potentially reduce the safety risks associated with currently commercially available drug-eluting stents, and improve long-term clinical outcomes.

MiStent has received CE marking, but is not approved for sale in the United States. Micell currently is preparing an FDA IDE submission for the CRYSTAL study, a prospective, multi-center, randomized trial comparing MiStent to commercially available everolimus drug-eluting stents.

About DESSOLVE III

DESSOLVE III is a prospective, balanced, randomized, controlled, single-blind, multi-center all-comers study comprising 1,400 patients. Enrollment was completed in December 2015. The study is being conducted independently by the European Cardiovascular Research Institute, Rotterdam, The Netherlands and is supported by Micell Technologies.