Biomimetic Stents for Infra-inguinal Peripheral Arterial Disease: Systematic Review and Meta-Analysis

Abstract

Objective: Biomimetic stents are peripheral infra-inguinal self-expanding stents that mimic the anatomy of the vasculature and artery movement. They are indicated for use in infra-inguinal arteries. This research aimed to synthesise all current evidence on the use of biomimetic stents as adjuncts for endovascular treatment of infra-inguinal peripheral arterial disease (PAD), helping to guide clinical decision making. Data sources: MEDLINE, Embase, CINAHL and Cochrane databases. Review methods: Random effects meta-analysis following PRISMA guidelines (PROSPERO registration CRD42022385256). Study quality was assessed using the Joanna Briggs Institute critical appraisal tools checklist, and certainty assessment through the Grading of Recommendations, Assessment, Development and Evaluation (GRADE). Endpoints included primary patency, target lesion revascularisation, stent fracture, secondary patency, and mortality at 1 year. Results: In total, 37 studies were included in the meta-analysis (33 cohort studies, 2 case series, and 2 randomised controlled trials [RCTs]), representing 4 480 participants. Of these, 34 studies included data on Supera (81.5% of participants) and 3 studies reported data on BioMimics 3D (18.5% of participants) stents. The pooled primary patency rate of 33 studies at 1 year follow up was 81.4% (95% confidence interval [CI] 78.7 - 83.9%), and the pooled target lesion revascularisation rate of 18 studies at 1 year was 12.2% (95% CI 9.6 - 15.0%). The certainty of evidence outcome rating as qualified by GRADE was very low for both. Only one study reported a positive stent fracture rate at 1 year follow up of 0.4% with a certainty of evidence outcome of low. Conclusion: Using biomimetic stents for infra-inguinal PAD may be associated with acceptable 1 year primary patency and target lesion revascularisation rates, with near negligible 1 year stent fracture rate. Their use should be considered in those presenting with infra-inguinal PAD undergoing endovascular revascularisation. A RCT trial is necessary to determine their clinical and cost effectiveness.