Ultrathin bioresorbable polymer sirolimus‐eluting stents in US patients undergoing coronary revascularization: 1‐Year outcomes from the BIOFLOW VII trial

Abstract

AbstractBackgroundUltrathin strut coronary drug‐eluting stents (DES) have demonstrated improved safety and efficacy in large contemporary trials. The evaluation of an ultrathin strut DES in a post‐market United States (US) patient population was undertaken.ObjectiveThe purpose of this post‐approval study is to confirm that the clinical performance of an ultrathin strut bioresorbable polymer sirolimus‐eluting stent (BP SES) in clinical practice is similar to that observed with BP SES in the BIOFLOW V pivotal trial.MethodsBIOFLOW VII is a prospective, multicenter, single‐arm US post‐market approval study to confirm the clinical performance of BP SES in a real‐world setting. The primary endpoint of 1‐year target lesion failure (TLF) was compared with a performance goal of 6.9% based on an adapted BIOFLOW V trial BP SES TLF rate and TLF rates from other US market‐released DES utilizing the Society for Cardiovascular Angiography and Interventions definition for peri‐procedural myocardial infarction (MI). Subjects undergoing percutaneous coronary intervention with BP SES were consented within 24 h post‐index procedure with planned follow‐up through 5 years.ResultsAmong 556 enrolled patients, clinical demographics included: 34.7% female, 35.6% with diabetes mellitus, and 56.8% with acute coronary syndromes. The average stent length (mean ± standard deviation) was 20.2 ± 11.8 mm, and the mean number of stents per patient was 1.3 ± 0.6. Procedure success was 99.1% (551/556), and device success was 99.9% (689/690). Among 531 subjects included in the primary endpoint analysis, the 1‐year rate of TLF rate was 1.7% (9/531), and the primary endpoint was met compared with the performance goal (p < 0.0001, 95% confidence interval: 0.69%, 3.43%). Rates of target vessel MI and clinically driven target lesion revascularization were 1.3% (7/531) and 0.9% (5/531), with no occurrence of cardiac death. Definite stent thrombosis was observed for two cases (0.4%; 2/556) with one acute (≤24 h) and one late (>30 days and ≤1 year) event.ConclusionIn a post‐approval study, 1‐year clinical outcomes with BP SES were consistent with prior trials supporting the safety and effectiveness of ultrathin BP SES.