Clinical outcomes of bioabsorbable polymer sirolimus-eluting stents versus durable polymer everolimus-eluting stents: two-year follow-up of the DESSOLVE III trial
Yuki Katagiri, Yoshinobu Onuma, Philipp Lurz, Paweł Buszman, Jan J. Piek, Joanna J. Wykrzykowska, Taku Asano, Norihiro Kogame, Kuniaki Takahashi, Chun Chin Chang, Robbert J. de Winter, Patrick W. Serruys, William Wijns
Abstract
AIMS: The aim of this study was to assess whether the nine months of cytostatic inhibition by crystalline sirolimus has a beneficial effect in the two-year follow-up in an all-comer population undergoing percutaneous coronary intervention. METHODS AND RESULTS: The DESSOLVE III study (n=1,398) is a prospective, all-comer, multicentre, randomised controlled study (NCT02385279) allocating 703 patients to receive the MiStent drug-eluting stent with a fully absorbable polymer coating containing and embedding a microcrystalline form of sirolimus into the vessel wall, and 695 patients to receive the XIENCE durable polymer everolimus-eluting stent. At two years, the device-oriented composite endpoint (cardiac death, target vessel myocardial infarction [TV-MI], and clinically indicated target lesion revascularisation [TLR]) occurred in 8.7% and 8.6% (p=0.958) of patients, and the patient-oriented composite endpoint (all deaths, all MI, and all revascularisations) was observed in 18.5% and 19.6% (p=0.598) of patients in the MiStent and XIENCE arms, respectively. The frequency of TV-MI and clinically indicated TLR was also comparable for both stent types. The rate of definite/probable stent thrombosis was not different in the two arms (0.9% vs 1.3%, p=0.435). CONCLUSIONS: In an all-comer population, at two-year follow-up, the use of the MiStent sirolimus-eluting bioabsorbable polymer-coated stent was at least as safe and efficacious as the XIENCE durable polymer stent. The MiStent's potential long-term clinical benefit will be further elucidated after five years of follow-up.