Aims: The aim of the study was to evaluate the two-year clinical outcome of all-comer trial participants who were treated with two very different thin-strut biodegradable polymer versus thin-strut durable polymer drug-eluting stents (DES). Prolonged clinical outcome after discontinuation of dual antiplatelet therapy is of particular interest, given the highly dissimilar polymer types, amount, distribution, and degradation speed of both biodegradable polymer DES.
Methods and results: The BIO-RESORT trial (NCT01674803) randomly assigned 3,514 patients to treatment with biodegradable polymer SYNERGY everolimus-eluting stents (EES) or Orsiro sirolimus-eluting stents (SES), or durable polymer Resolute Integrity zotarolimus-eluting stents (ZES). At two-year follow-up (available in 98.8%), the rate of the primary composite endpoint target vessel failure (TVF) was 8.3% in ZES versus 6.8% in EES (p=0.19) and 6.6% in SES (p=0.12). Landmark analyses at one year revealed differences between SES and ZES in the rates of target lesion revascularisation and target lesion failure (0.6% vs. 1.5%, p=0.04, and 1.1% vs. 2.4%, p=0.02, respectively) as well as other composite secondary endpoints that reached statistical significance.
Conclusions: At two-year follow-up, there was no significant between-DES difference in the rates of the primary endpoint. Landmark analyses provided a signal that the use of SES versus ZES might reduce the risk of repeat revascularisation after one-year follow-up.