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Drug-coated balloon (DCB) have emerged as a therapeutic alternative in the treatment of peripheral vascular disease. The aim of this study was designed to evaluate the safety and efficacy of a Ranger DCB in a swine femoral artery model.
The femoral arteries of 42 swine were treated with low pressure balloon inflation either 1x clinical dose (single inflation, 2 mg/mm2 paclitaxel) or 3x dose (2 overlapping DCBs, each with 3 mg/mm2 paclitaxel) or control (uncoated) balloons. We performed histologic analysis of arterial wall and downstream skeletal muscle and coronary band at 7, 30, and 90-days. Scanning electron microscopy (SEM) evaluation of 1x dose DCB and control balloons were performed at 7 and 30-days. Pharmacokinetic analysis comparing other available DCBs (In. Pact and Lutonix) to 1x Ranger DCB was also performed.
Arterial tissue paclitaxel concentration of Ranger DCB was higher than published Lutonix and similar to In. Pact (Ranger DCB vs. Lutonix vs. In. Pact; 4.73 ng/mg vs. 1.5 ng/mg vs. 8.0 ng/mg at 7-days, 1.37ng/mg vs. 0.34 ng/mg at 42 and 45 days, respectively). Lutonix data was reported at 30 days as 0.3 ng/mg. The 1x treated arteries demonstrated minimal endothelial loss, fibrin deposition, inflammation. % stenosis peaked at 30d and declined thereafter (7- vs. 30- vs. 90-day; 5.5±1.7%, 21.6±12.5%, 15.8±7.5%, respectively). Drug effect showed similar trends (smooth muscle cell [SMC] loss score, 7- vs. 30- vs. 90-day; 0.50±1.07, 1.94±1.27, 1.75±0.60, respectively). In parallel, healing score (medial proteoglycan and collagen deposition) of the treated arteries for 3x dose was significantly greater at 180 days (7- vs. 30- vs. 90-day; 1.8±1.0, 1.8±1.0, 2.3±0.7, respectively). The occurrence of downstream emboli was low in all time points even for 3x DCB groups (7- vs. 30- vs. 90-day; 0.0%, 0.0%, 4.5%, respectively). SEM analysis demonstrated similar endothelialization score for 1x dose and control balloons at both 7- and 30-days.
The findings indicated well balanced drug effect at early phase and healing at late time points, with low occurrence of downstream emboli, consistent with safety of the Ranger DCB.