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

• Published in: Catheterization and cardiovascular interventions Vol. 102; no. 3; pp. 464 - 471
• Main Authors: Kandzari, David E., Garcia‐Garcia, Hector M., Stoler, Robert C., Wang, John, Picone, Mark, Ben‐Dor, Itsik, Garcia, Santiago A.
• Format: Journal Article
• Language: English
• Published: United States Wiley Subscription Services, Inc 01.09.2023
• Subjects: Angiography; Clinical trials; Diabetes mellitus; Implants; Myocardial infarction; Rapamycin; Stents; Thrombosis; United States > US; percutaneous coronary intervention; bioresorbable polymer; ultrathin strut drug-eluting stent; myocardial infarction; sirolimus
• ISSN: 1522-1946; 1522-726X; 1522-726X
• DOI: 10.1002/ccd.30783

Ultrathin 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. The 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. BIOFLOW 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. Among 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. In 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.