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

Abstract

To assess the safety and efficacy of the Absorb bioresorbable vascular scaffold (BVS) in complex, infrapopliteal lesions for the management of chronic limb ischemia. 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. 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. 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. 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.