Efficacy of Bioresorbable Vascular Scaffolds in Below-the-Knee Arterial Disease: A Single-Arm Systematic Review and Meta-Analysis.

BACKGROUND

Below-the-knee (BTK) lesions in peripheral artery disease (PAD) are associated with high restenosis rates and poor limb outcomes. Bioresorbable vascular scaffolds (BVS) have emerged as temporary vessel support that may overcome the limitations of balloon angioplasty and metallic stents. However, their efficacy and safety in BTK revascularization remain uncertain.

METHODS

A systematic review and single-arm meta-analysis were performed by searching PubMed, Embase, Cochrane Library, Web of Science, and Scopus from inception to October 2025. Studies reporting at least 1-year outcomes after BVS implantation in BTK lesions were included. Primary efficacy end points were 1-year patency, freedom from target lesion revascularization (TLR), and clinical remission; safety end points included all-cause mortality and perioperative complications. Random- or fixed-effects models were applied according to heterogeneity.

RESULTS

Eleven studies with 591 patients were included (1 randomized, 3 prospectives, 6 retrospectives, and 1 conference abstract). The average lesion length across included studies ranged from 20.1 mm to 43.8 mm. The pooled 1-year patency, freedom from TLR, and clinical remission rates were 90% (95% confidence interval (CI): 0.85-0.95, I2 = 63.8%), 94% (95% CI: 0.92-0.96, I2 = 0.0%), and 83% (95% CI: 0.79-0.86, I2 = 0.0%), respectively. The pooled perioperative complication and 1-year mortality rates were 3% and 9%. Sensitivity analysis confirmed the robustness of pooled estimates, while heterogeneity remained moderate for patency. The overall quality of evidence was low due to the observational design of most studies.

CONCLUSION

BVS demonstrate favorable short-term safety and efficacy in BTK revascularization. However, as this single-arm meta-analysis lacks comparator data and includes mostly small, nonrandomized studies, the results should be interpreted as exploratory. Larger, randomized controlled trials with long-term follow-up are warranted to validate these findings and define the role of BVS in BTK arterial disease.