Micell Technologies has announced that long-term clinical outcomes from its DESSOLVE I and II clinical trials were presented at the EuroPCR conference in Paris, France this week.
Presentations by principal investigator Dr William Wijns of the Cardiovascular Center in Aalst, Belgium, highlighted results of long-term clinical follow-up of the MiStent Sirolimus eluting absorbable polymer coronary stent system.
MiStent SES is a thin-strut drug-eluting stent with a bioabsorbable polymer intended to optimize vessel healing in patients with coronary artery disease.
Dr Wijns said that the two- and three-year data demonstrate the long-term safety and efficacy of MiStent SES’s unique design.
"Importantly, the crystal sirolimus component of this novel stent provides a slow, controlled release that maintains therapeutic levels of drug in tissue for up to nine months, achieving long-term drug delivery without long-term polymer exposure," Dr Wijns added.
The presentations at EuroPCR were, ‘Long-Term Clinical Results from the DESSOLVE I First-In-Human Trial and the DESSOLVE II Randomised Trial of a Sirolimus-Eluting Stent with Fully Absorbable Polymer’ and ‘DESSOLVE II Trial Results: Two-Year Follow-up of a Crystalline Sirolimus-Eluting Stent with Rapid Bioabsorbable Polymer’.
In the DESSOLVE I and II trials, patients with discrete de novo lesions in native coronary arteries were enrolled and followed for clinical events at predefined intervals. An evaluation of clinical follow-up at three years was presented for DESSOLVE I; at this point, there were no target vessel MACE events for MiStent SES, and two non-target vessel non-Q wave myocardial infarctions were reported.
In addition, there was no evidence of stent thrombosis or target lesion revascularizations. Clinical outcomes at two years were presented for DESSOLVE II; in this study, MACE for MiStent SES was 6.7%, there was no definite or probable stent thrombosis and target lesion revascularization was 1.7%.