October 18, 2020
9-Month Data Presented From IN.PACT BTK Feasibility Study of Medtronic's In.Pact DCB to Treat CLI
October 18, 2020—Medtronic announced the first results from IN.PACT BTK, a feasibility study assessing the safety and effectiveness of the company's In.Pact 0.014 drug-coated balloon (DCB) in critical limb ischemia (CLI) patients with chronic total occlusion (CTO) in the infrapopliteal arteries.
The data were presented in the late-breaking clinical trial sessions at TCT Connect, the 32nd annual Transcatheter Cardiovascular Therapeutics scientific symposium of the Cardiovascular Research Foundation held online October 14-18, 2020.
According to Medtronic, IN.PACT BTK is a prospective multicenter 1:1 randomized feasibility study assessing the safety and effectiveness of the In.Pact 0.014 DCB, a 3.5-μg/mm2 dose paclitaxel-coated balloon, versus conventional percutaneous transluminal angioplasty (PTA) for the treatment of CTOs in the infrapopliteal arteries. The study enrolled 50 patients at nine sites in Europe.
The study's effectiveness endpoint evaluated 9-month late lumen loss, specifically sub-segmental late lumen loss and classic late lumen loss. The safety endpoint evaluated a composite of freedom from device- and procedure-related mortality within 30 days, freedom from major target limb amputation within 9 months, and freedom from clinically driven target limb revascularization (CD-TLR) within 9 months post-index procedure.
The company reported that at 9 months, patients in the DCB group experienced a reduction in subsegmental late lumen loss compared to those in the PTA control group (0.59 mm ± 0.94 mm vs 1.26 mm ± 0.81 mm; P = .017), a 53% lower late lumen loss than the PTA control group. Using the classic late lumen loss method, patients in the DCB group experienced lower late lumen loss compared to those in the PTA control group at 9 months (0.89 mm ± 0.77 mm vs 1.31 mm ± 0.72 mm; P = .07), a 32% lower late lumen loss than the PTA control group.
Additionally, there was no statistical difference in the safety composite endpoint within 9 months between the DCB group and PTA control group (91.3% vs 87.5%; P = 1.00).
Safety outcomes for the DCB versus PTA groups included freedom from device and procedure-related death through 30 days (0.0% vs 3.7%; P = 1.00); freedom from target limb major amputation within 270 days (0.0% vs 0.0%; P > .999); and freedom from CD-TLR within 270 days (8.7% vs 8.7%; P = 1.00).
“The design of this feasibility study is incredibly thorough and required rigorous procedural, duplex ultrasound, and angiographic protocols to more accurately evaluate these complex lesions,” commented Antonio Micari, MD, in Medtronic's announcement. “Despite enrolling subjects with challenging lesions commonly seen in BTK disease, including those with CTOs, long lesions, and severe calcification, the results of the study are promising.” Dr. Micari is from the Department of Invasive Cardiology, University of Messina, in Messina, Italy.