Comparison of Biologic Effect and Particulate Embolization after Femoral Artery Treatment with Three Drug-Coated Balloons in Healthy Swine Model

Purpose: To investigate morphometric characteristics and differences in particulate embo ization between 3 drug-coated balloons (DCBs). Materials and Methods: Effects of 3 overlapping DCBs (IN.PACT, Ranger, and Stellarex) were assessed in 24 femoral arteries of 12 swine with 28-day follow-up. Histologic analysis of treated arterial wall site and downstream skeletal muscle and coronary band changes were assessed for evidence of emboli. Paclitaxel concentration for downstream skeletal muscle and coronary band and vessel diameters with downstream changes were also measured. Results: Signs of drug effect, such as medial smooth muscle cell (SMC) loss in depth and circumference, were not significantly different for all 3 DCBs (IMPACT vs Ranger vs Stellarex: SMC loss depth, 2.8 [interquartile range [IQR]: 2.1-3.6] vs 3.2 [IQR: 2.3-3.8] vs 3.5 [IQR: 2.6-3.8], P =.7; SMC loss circumference, 1.0 [IQR: 1.0-1.0] vs 1.3 [IQR: 1.0-1.8] vs 1.0 [IQR: 1.0-1.2], P =.08). Percentage of sections with vascular changes in downstream nontarget tissues from arteries was similar in all 3 DCBs (42.9% vs 25.0% vs 28.6%, P =.2). Downstream levels of paclitaxel concentration in skeletal muscle were significantly higher for IN.PACT (216.5 ng/g vs 91.5 ng/g vs 101.9 ng/g, P =.01). Median vessel diameters with evidence of downstream changes were smallest for IN.PACT compared with Ranger and Stellarex (57 mu m vs 74 mu m vs 64 mu m). Conclusions: All 3 DCBs exhibited no significant difference in local target site drug effect based on histologic analysis. Downstream effects of paclitaxel and/or downstream emboli were highest for IN.PACT compared with Ranger and Stellarex, whereas vessel diameters with evidence of downstream changes were smaller for IN.PACT vs Ranger and Stellarex.