The MiStent Sirolimus eluting absorbable polymer coronary stent system (MiStent SES) optical coherence tomography (OCT) study has completed enrolment, according to a press release from Micell Technologies.
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 randomised to MiStent or Xience. A prior MiStent clinical study has shown a low level 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 randomised 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, Micell’s chief medical advisor, says, “Many drug-eluting stents have a yearly increase in revascularisation rate, typically doubling the one year revascularisation 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 revascularisation. This would represent a patient benefit over current drug-eluting stents.”