Comparative Investigation on Polymer Drug-coating Balloons Used in Infrapopliteal Angioplasty Based on Angiosomes Concept

Abstract

Atherosclerosis can affect the blood vessels in any region of the body and the stenosis (narrowing) can be located on an artery that vascularize important organs, such as the brain, abdominal organs or limbs. The endovascular surgery is a modern approach to vascular pathology through minimally invasive techniques (puncture, minimally vascular approach) and it represents an enrichment of the arsenal of surgical techniques and brings considerable improvements in post-operative and long-term outcomes The use of polymer drug-coating balloons is an attractive alternative because they can offer the promise of an improved patency compared to the simple balloons and a reduction in the need for stents. The aims of this study were to describe the polymer materials and to compare the medical endpoints obtained in angiosome-targeted infrapopliteal angioplasty using a simple balloon with two layers, based on polyethylene, and respectively a drug-coated balloon that contains a multiblock copolymer from polyethylene, poly(cylohexylethylene), polyisoprene and poly(1,3-butadiene) covered by Paclitaxel. The balloons were characterized by differential scanning calorimetry, stress-strain and puncture tests in order to describe their physical and mechanical characteristics. On the other hand, 51 patients with critical limb ischemia were treated with different balloon angioplasty and they were monitored for 12 months after the intervention; the following parameters have been evaluated: diabetes, hypertension, renal insufficiency, hemodialysis, stroke, dyslipidemia, heart disease, heart failure, body mass index, number of angiosomes, creatinine, and wound healing, leg salvage and amputation-free survival at 1, 2, 3, 6, 9, 12 months. Significant associations were found in the case of anterior-tibial-artery and posterior-tibial-artery angioplasy and the age, hypertension and renal insufficiency. On the other hand, the results indicate that the drug deposition on the surface of the balloons lead to improved values for the observed medical endpoints. In conclusion, this study reveals that angiosome-based infrapopliteal angioplasty with drug-coated balloons can be associated with better wound healing and leg salvage.