Long-term clinical outcomes of a crystalline sirolimus-eluting coronary stent with a fully bioabsorbable polymer coating: five-year outcomes from the DESSOLVE I and II trials.

Abstract

The aim of this study was to evaluate the five-year clinical results of a sirolimus-eluting stent (MiStent SES) with a bioabsorbable coating designed for sustained drug delivery during and after rapid polymer dissolution. The five-year results from the DESSOLVE I and II trials including major adverse cardiac events (MACE), target lesion failure (TLF), target vessel failure (TVF), and stent thrombosis (ST) at five-year follow-up are reported. In DESSOLVE I, 10.3% of patients receiving the MiStent SES (3/29) had a MACE event up to five years without TLF. In DESSOLVE II, 15.1% of patients in the MiStent group (18/119) had a five-year MACE event compared to 22.0% of patients in the Endeavor group (p=0.295). TLF was 9.2% in the MiStent group and 8.5% in the Endeavor group (p=1.00). TVF was 10.1% for MiStent versus 15.3% for Endeavor (p=0.331). Up to five-year follow-up, the MiStent SES has continued to demonstrate low rates of TLR across DESSOLVE I (0.0%) and DESSOLVE II (3.4%). No ST was reported with the MiStent up to five years in the DESSOLVE I trial. In DESSOLVE II, definite or probable ST was 0.0% with MiStent and 1.7% with Endeavor up to five years. The MiStent SES demonstrated long-term safety and effectiveness with low rates of five-year MACE, TLF, and TVF across these two clinical trials.