Ultrathin Bioresorbable Polymer Sirolimus-Eluting Stents in US Patients Undergoing Coronary Revascularization: 2-Year Outcomes From the BIOFLOW VII Trial

Background: Contemporary large-scale trials have demonstrated enhanced safety and efficacy for ultrathin strut coronary drug-eluting stents. A postmarket US study evaluating ultrathin strut drug-eluting stents committed to long-term follow-up was performed to evaluate the long-term clinical results following percutaneous coronary intervention with ultrathin strut (60 μm) bioresorbable polymer sirolimus-eluting stents (BP SES) in real-world clinical practice. Methods: BIOFLOW VII is a prospective, multicenter, single-arm registry examining the clinical effectiveness of an ultrathin strut (60 μm) BP SES with dedicated follow-up through 5 years. The primary end point of 12-month target lesion failure (TLF) was previously reported. A prespecified analysis of 2-year clinical outcomes was performed. Results: BIOFLOW VII enrolled 556 patients at 31 sites in the United States. The average stent length (mean ± SD) was 20.2 ± 11.8 mm, and the mean number of stents per patient was 1.3 ± 0.6. The 2-year TLF rate was 5.2% (27/522). TLF component rates included cardiac death, 1.7% (9/522); target vessel-related myocardial infarction, 1.7% (9/515); and ischemia-driven target lesion revascularization, 2.7% (14/515). Definite stent thrombosis was observed in 3 cases (0.5%): 1 acute (≤24 hours), 1 late (>30 days and ≤1 year), and 1 very late (>1 year) event. Conclusions: The 2-year BIOFLOW VII results demonstrate the durability of efficacy and safety of ultrathin BP SES. Favorably low rates of ischemia-driven target lesion revascularization and definite late/very late stent thrombosis were concordant with prior trials with ultrathin BP SES.