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%.
