Building on previous below-the-knee (BTK) drug-coated balloon (DCB) studies, IN.PACT BTK assessed the safety and effectiveness of DCB angioplasty versus plain balloon angioplasty in the infrapopliteal arteries. In critical limb ischemia (CLI) patients with chronic total occlusions, the IN PACT .014 BTK DCB demonstrated effectiveness through nine months compared to percutaneous transluminal angioplasty (PTA) in a complex population and found no safety concerns. Specifically, at 9 months, there was a large separation in the DCB treated sub-segmental late lumen loss compared to those in the PTA alone group. (0.59mm+/- 0.94 mm versus 1.26mm+/- 0.81 mm respectively, p=0.017 which translates into a 53% lower late lumen loss in the DCB group. When one examines LLL in a classic fashion (compared to subsegmental), DCB therapy resulted in less LLL (0.89+/- 0.77 vs 1.31 mm+/- 0.72mm, p=0.07) compared to plain PTA which is a 32% relative reduction in LLL. Paramount to this study is the safety of this device, with no target limb amputations within 270 days, and no device and procedure related deaths in the DCB arm. Though there was a statistical decrease in both types of LLL measured, there was no difference in CD-TLR within 270 days (8.7% in the DCB group vs. 8.7% in the PTA group, p=1.0000).

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