Abstract
Objective:
Drug-eluting resorbable scaffold (DRS) has emerged as a promising adjunctive treatment to traditional percutaneous transluminal angioplasty (PTA) for infrapopliteal arterial disease. This systematic review aims to evaluate the clinical efficacy and safety of DRS in this application.
Methods:
PubMed, ScienceDirect, and Embase databases were systematically searched as of November 2025. Studies concerning infrapopliteal arterial revascularization using DRS were included. The primary endpoints were 12-month primary patency rate and freedom from clinically driven target vessel revascularization (CD-TLR). Secondary endpoints included 12-month limb salvage rate and 30-day all-cause mortality.
Results:
Seven studies, comprising 1 randomized controlled trial, 3 prospective, and 3 retrospective studies, including 497 patients were included in the analysis. Treatment of infrapopliteal arterial lesion with DRS yielded a 12-month primary patency of 88% (95% CI = 0.81-0.93) and a 12-month freedom from CD-TLR of 95% (95% CI = 0.93-0.97). The 12-month limb salvage rate was 99% (95% CI = 0.97-1.00), and freedom from 30-day all-cause mortality rate was 99% (95% CI = 0.97-1.00).
Conclusion:
Drug-eluting resorbable scaffold was associated with high patency and low reintervention rates in this systematic review of predominantly observational studies. Nevertheless, additional large-scale randomized controlled trials are warranted for direct comparison between DRS and PTA and further investigation to establish long-term durability.
Clinical Impact
By summarizing recent data from interventional and observational studies, this systematic review demonstrated favourable efficacy and safety of drug-eluting resorbable scaffolds (DRS) in the treatment of infrapopliteal arterial disease. While superiority of DRS over conventional balloon angioplasty alone could not be established due to limited randomized trials and lack of long-term follow-up. The available data support use of DRS as an adjunctive option in selected patients with chronic limb-threatening ischemia.
Keywords
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Supplementary Material
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