Evaluation of a crystalline sirolimus-eluting coronary stent with a bioabsorbable polymer designed for rapid dissolution: two-year outcomes from the DESSOLVE I and II trials

Abstract

Aims: Our aim was to evaluate the two-year clinical results of a new sirolimus-eluting stent (MiStent SES) with a bioabsorbable coating designed for rapid polymer dissolution but sustained drug delivery.

Methods and results: Major adverse cardiac events (MACE), target lesion failure (TLF), target vessel failure (TVF), and stent thrombosis (ST) at two-year follow-up are reported for the DESSOLVE I and II trials. In DESSOLVE I, the MiStent SES (n=29) demonstrated a 3.4% two-year MACE rate without TLF or TVF. In DESSOLVE II, the MiStent group had a 6.7% (8/120) two-year MACE rate compared to 13.3% (8/60) for Endeavor (p=0.167). TLF was 5.0% in the MiStent and Endeavor groups (p=1.00). TVF was 5.0% for MiStent versus 11.7% for Endeavor (p=0.129). No probable or definite ST was reported with the MiStent up to two years. The median duration of dual antiplatelet therapy (DAPT) in DESSOLVE I and II was 364 and 366 days, respectively.

Conclusions: The MiStent SES demonstrated good long-term safety and effectiveness with low two-year MACE, TLF, and TVF rates.