Micell Technologies announced completion of enrollment in the MiStent® Sirolimus Eluting Absorbable Polymer Coronary Stent System (MiStent SES) Optical Coherence Tomography (OCT) study.
The study will compare changes in coronary arteries between six and 24 months following treatment with MiStent or XIENCE V Everolimus Eluting Coronary Stent System (Xience). The clinical investigation and data analysis are being conducted by Cardialysis and the European Cardiovascular Research Institute (ECRI), in Rotterdam, The Netherlands.
The OCT study will evaluate 60 patients randomized to MiStent or Xience. A prior MiStent clinical study has shown essentially no increase in late lumen loss between six and 18 months’ follow-up.
Xience has demonstrated almost a doubling of late lumen loss in long-term follow-up. This OCT study has the potential to show superiority of MiStent SES against Xience, with significantly less progression of in-stent percent volume obstruction and frequency of neoatheroma formation over time.
It is part of the larger DESSOLVE III study, which is a 1:1 randomized comparison of Target Lesion Failure (TLF) at 12 months for MiStent versus Xience in 1,400 patients. Results from DESSOLVE III are expected to be available in the first quarter of 2017.
Dennis Donohoe, M.D., Micell’s chief medical advisor said, "Many drug-eluting stents have a yearly increase in revascularization rate, typically doubling the one year revascularization rate by four to five years’ follow-up. We are optimistic that we will find significantly less progression of neointimal hyperplasia with MiStent, suggesting a low rate of late revascularization. This would represent a patient benefit over current drug-eluting stents."
"Micell thanks the Steering Committee consisting of Patrick W. Serruys, M.D., Ph.D., Professor of Interventional Cardiology at Erasmus University, Rotterdam, The Netherlands; Robbert J. de Winter, M.D., Ph.D., Professor of Clinical Cardiology, Academic Medical Center, Amsterdam, The Netherlands; and William Wijns, M.D., Ph.D., Co-Director of the Cardiovascular Center, Aalst, Belgium; Cardialysis, and ECRI," said Arthur J. Benvenuto, chairman and chief executive officer.
MiStent SES has CE Mark in the European Union and is being distributed exclusively by STENTYS around the world, with the exception of the United States, Canada, China, South Korea and Japan. STENTYS currently is conducting a controlled launch in select countries in Western Europe, the Middle East and Asia.
MiStent SES® is designed to optimize healing in patients with coronary artery disease. The rapidly absorbable coating of the MiStent SES, which contains crystalline drug (sirolimus) and an absorbable polymer, is intended to precisely and consistently provide for 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.
Using an approved drug (sirolimus) and polymer (PLGA), Micell’s patented supercritical fluid technology allows a rigorously controlled drug/polymer coating to be applied to a bare-metal stent.
The MiStent SES leverages the benefits of a cobalt chromium coronary stent system, a state-of-the-art, thin-strut, bare-metal stent, which has demonstrated excellent deliverability, conformability and flexibility.
EU approval of MiStent SES was supported by clinical data from two studies, DESSOLVE I and II, which demonstrated superior in-stent late lumen loss rates and an excellent safety profile. Four-year data were presented in October 2015 at the 27th Annual Transcatheter Cardiovascular Therapeutics (TCT) Conference by Alexandra Lansky, M.D., Director, Yale Cardiovascular Clinical Research Program, Yale School of Medicine, New Haven, Conn.
Highlights of the data include no target lesion events in the DESSOLVE I study and sustained clinical outcomes in both DESSOLVE I and II through four years’ follow-up. There have been no probable or definite stent thromboses in either study.
Importantly, MiStent SES continues to show a low combined target lesion revascularization (TLR) rate for DESSOLVE I and II of 2.7% at four years’ follow-up, which is consistent with the previously demonstrated lack of late loss progression in the DESSOLVE I study.