Ultrathin Bioresorbable Polymer Sirolimus-Eluting Stents versus Thin Durable Polymer Everolimus-Eluting Stents for Coronary Revascularization: Three-year Outcomes from the Randomized BIOFLOW V Trial

Abstract Objectives To compare late-term clinical outcomes among patients treated with ultrathin strut (60μm) bioresorbable polymer sirolimus-eluting stents (BP SES) and thin strut (81μm) durable polymer everolimus-eluting stents (DP EES). Background Emerging evidence from comparative study of drug-eluting stents (DES) demonstrates improved safety and efficacy with ultrathin strut DES, yet limited insight exists regarding late-term outcomes. Methods BIOFLOW V is an international randomized trial comparing coronary revascularization with BP SES and DP EES regarding the primary endpoint of 12-month target lesion failure (TLF). Analysis of pre-specified 3-year clinical outcomes was performed. Results Among 1,334 patients randomized to treatment with BP SES (884 patients) or DP EES (450 patients), the 3-year rate of TLF was 8.2% for BP SES and 13.6% for DP EES (P=0.002) driven by differences in both target vessel myocardial infarction (MI; 5.0% versus 9.2%, P=0.003) and clinically-driven target lesion revascularization (TLR; 3.2% versus 6.7%, P=0.006). In landmark analysis, significant differences in target vessel MI and TLR were observed favoring treatment with BP SES. Definite/probable late/very late stent thrombosis was significantly lower with BP SES (0.1% versus 1.2%, P=0.018). Cardiac death or MI rates were 7.7% versus 11.7% (P=0.02) for BP SES and DP EES, respectively. Conclusion In a large randomized trial, both TLF and the outcomes of target vessel MI, clinically-driven TLR and late/very late stent thrombosis at 3-years were significantly lower among patients treated with BP SES versus DP EES. The results endorse the continued superiority of ultrathin strut BP SES compared with DP EES.