David E. Kandzari, Jacques J. Koolen, Gheorghe Doros, Joseph J. Massaro, Hector M. Garcia-Garcia, Johan Bennett, Ariel Roguin, Elie G. Gharib, Donald E. Cutlip, Ron Waksman, BIOFLOW V Investigators

Coronary drug-eluting stent development has introduced new metal alloys, changes in stent architecture and bioresorbable polymers. Whether these advancements improve long-term clinical safety and efficacy has been inconsistent in prior studies. To compare late-term clinical outcomes among patients treated with an ultrathin strut (60 μm) bioresorbable polymer sirolimus-eluting stent (BP SES) and a thin strut (81 μm) durable polymer everolimus-eluting stent (DP EES) in a large randomized trial. BIOFLOW V was 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 2-year clinical outcomes was performed. Among 1,334 patients randomized to treatment with BP SES (884 patients) or DP EES (450 patients), the two-year TLF rate was 7.5% for BP SES and 11.9% for DP EES (-4.33% treatment difference, 95% CI -8.16% to -0.91%, P=0.015), driven by differences in target vessel myocardial infarction (MI; 5.3% versus 9.5%, P=0.01) and ischemia-driven target lesion revascularization (TLR; 2.6% versus 4.9%, P=0.04). Rates of cardiac death or MI were 7.0% versus 10.4% for BP SES and DP EES, respectively (P=0.047). Late/very late definite stent thrombosis was statistically lower for BP SES compared with DP EES (0.1% versus 1.0%, P=0.045). In a large randomized trial, significant differences in both TLF and target vessel-related MI persisted through 2 years favoring treatment with BP SES over DP EES. Significantly lower cumulative TLR and late/very late stent thrombosis were also observed with BP SES.