Contemporary Indications for Bioresorbable Scaffolds for Infrapopliteal Peripheral Artery Disease: An International Expert Consensus.

BACKGROUND

Endovascular treatment of below-the-knee disease in chronic limb-threatening ischemia remains challenging, with limited durability of balloon angioplasty and constraints associated with permanent metallic implants. Drug-eluting resorbable scaffolds (DRS) provide temporary vessel support with local drug delivery followed by bioresorption, representing a promising alternative. However, the optimal clinical scenarios for DRS use remain undefined. This study aimed to establish consensus on DRS use in infrapopliteal revascularization.

METHODS

A multidisciplinary steering committee developed a structured questionnaire addressing lesion characteristics, patient-level clinical factors, and health-system considerations. Using the RAND/UCLA Appropriateness Method and a modified Delphi process, 114 clinical scenarios were evaluated by an international panel of experts in vascular surgery, interventional cardiology, interventional radiology, and vascular medicine. Experts rated each scenario using a 5-point Likert scale. Consensus strength was defined as strong (>80% agreement), partial (60% to 80%), or absent (<60%).

RESULTS

Thirty-five international experts completed the survey. Strong consensus was achieved for 44 scenarios (38.6%), partial consensus for 35 (30.7%), and no consensus for 35 (30.7%). Strong agreement supported DRS use in patients with CLTI (Rutherford 4-6), vessel diameter ≥3 mm, lesions ≤60 mm, and following adequate vessel preparation, particularly in centers with high procedural expertise and advanced imaging capabilities. Partial consensus emerged for longer or moderately complex lesions and certain clinical contexts. Lack of consensus was observed in small-vessel disease, complex bifurcations, long-segment disease requiring multiple scaffolds, thrombotic lesions, and scenarios involving interruption of antiplatelet therapy.

CONCLUSIONS

This consensus defines appropriate clinical scenarios for BTK DRS use, while areas of disagreement identify evidence gaps and research priorities as scaffold technologies evolve.