Single arm retrospective study of bioresorbable vascular scaffolds to treat patients with severe infrapopliteal arterial disease. Journal Article

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Authors: Dia, A; Venturini, JM; Kalathiya, R; Besser, S; Estrada, R; Friant, J; Paul, J; Blair, JE; Nathan, S; Shah, AP
Article Title: Single arm retrospective study of bioresorbable vascular scaffolds to treat patients with severe infrapopliteal arterial disease.
Abstract: OBJECTIVES: To assess the safety and efficacy of the Absorb bioresorbable vascular scaffold (BVS) in complex, infrapopliteal lesions for the management of chronic limb ischemia. BACKGROUND: The interventional management of infrapopliteal PAD remains challenging due to high restenosis rates with metallic drug-eluting stents and balloon angioplasty. Metallic stents are associated with impaired vessel vasomotor tone, remodeling, autoregulation, and long-term inflammation. BVSs are biodegradable scaffolds that provide short-term vascular support before degrading to allow restoration of vasomotor tone and endothelial function. A recent trial reported excellent 12-month vessel patency rates in simple infrapopliteal arterial lesions treated with Absorb BVS. METHODS: This single-center, retrospective study evaluated the use of the Absorb BVS (everolimus impregnated poly-L-lactic scaffold) in patients with infrapopliteal PAD with respect to safety (thrombosis and TIMI bleeding), technical success, and clinically driven target vessel failure (CD-TVF) at 12?months. RESULTS: Thirty-one patients (51.6% male) with a median age of 67?years with advanced infrapopliteal disease were treated with 49 BVS in 41 vessels. The mean stenosis was 94% (80-100), with 49% of lesions being CTOs. No scaffold thrombosis or periprocedural bleeding was observed. Procedural success was achieved in all patients. Freedom from CD-TVF was 95.1% at 12?months driven by one revascularization and one amputation. Primary patency was 96.7% at 12?months. All patients were alive at 12?months, and 96.8% of patients improved their Rutherford-Becker classification. CONCLUSIONS: At 12?months, our study found that patients with advanced infrapopliteal PAD who were treated with Absorb BVS reported improved clinical status and a low rate of CD-TVF.
Journal Title: Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography Interventions
ISSN: 1522-726X; 1522-1946
Publisher: Unknown  
Date Published: 2019