Clinical outcomes of bioabsorbable polymer sirolimus-eluting stents versus durable polymer everolimus-eluting stents: Two-year follow-up of the DESSOLVE III trial
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 [TVMI], 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.
|Keywords||ACS/NSTE-ACS, Clinical trials, Drug-eluting stent, Stable angina|
|Persistent URL||dx.doi.org/10.4244/EIJ-D-18-00944, hdl.handle.net/1765/126306|
Katagiri, Y, Onuma, Y, Lurz, P, Buszman, P.E, Piek, J.J, Wykrzykowska, J.J, … Wijns, W. (2020). Clinical outcomes of bioabsorbable polymer sirolimus-eluting stents versus durable polymer everolimus-eluting stents: Two-year follow-up of the DESSOLVE III trial. EuroIntervention, 15(15), E1366–E1374. doi:10.4244/EIJ-D-18-00944