Novel thin-strut, bioabsorbable sol-gel coated, low-dose paclitaxel-eluting stent: evaluation in porcine coronary arteries

Purpose: The purpose of our study was to evaluate the procedural success, 6-month patency, and clinical outcome of a new 4F sheath-compatible, selfexpanding nitinol stent after failed conventional angioplasty or atherectomy of infrapopliteal lesions in critical limb ischemia (CLI). Methods: Clinical records of 13 patients with CLI (Rutherford class 4–6), who underwent stent implantation following percutaneous transluminal angioplasty (PTA) and/or atherectomy were reviewed. Stent placement was carried out due flow-limiting dissections, or elastic recoil after PTA. Before and after the intervention and during the 6-month follow-up, clinical evaluation and color-flow and duplex Doppler ultrasonography were performed. Technical success, primary patency at 6 months, and clinical improvement as defined by Rutherford with clinical and hemodynamic measures and complications were evaluated. Results: A total of 19 arterial territories were intervened upon. 4F Sheathcompatible, self-expanding nitinol stent system (XPERT; Abbott Vascular) with a diameter of 3–5 mm and a length of 20–60 mm was used. A total of 29 stents were deployed. Stent implantation was successfully performed in all patients. After stent placement, the primary cumulative patency rate for the study group at 6 months was 90%. The mean resting ankle-brachial index at baseline was 0.40±0.1 and significantly increased to 0.90±0.13 (Pb.001) at 24 h after intervention and 0.84±0.15 at 6-month follow-up (P b.001). The sustained clinical improvement rate was 78% at the 6-month follow-up. The 6-month limb salvage rate regarding major amputation was 85%. One patient (7.7%) developed major access site bleeding requiring transfusion. Conclusions: Nitinol self-expanding stents in infrapopliteal arteries can be deployed safely with good short-term patency rate and clinical benefit in the treatment of CLI.