The IN.PACT 014 below-the-knee (BTK) paclitaxel drug-coated balloon (DCB) demonstrated effectiveness through nine months compared with conventional percutaneous transluminal angioplasty (PTA) in a complex population, according to researchers presenting the IN.PACT BTK study Oct. 18 during TCT 2020.

The randomized study assessed the safety and effectiveness of the IN.PACT 014 DCB (N=23) compared with PTA (N=27) at nine months for the treatment of critical limb ischemia patients with chronic total occlusions in the infrapopliteal arteries. The study's effectiveness endpoint was late lumen loss at nine months after the index procedure. The primary safety endpoint was a composite of 30-day freedom from device- and procedure-related mortality and freedom from major target limb amputation.

Antonio Micari, MD, et al., noted no safety concerns and said the results support consistency of a full IN.PACT clinical program. The safety composite was 91.3% in the DCB group compared with 87.5% in the PTA group. There were also no major amputations within nine months in either arm. Low rates of all-cause mortality were observed in 4.3% of the DCB group vs. 8.0% in the PTA group.

"This novel, randomized, feasibility study ... provides opportunity to affect future BTK studies and treatment algorithms," the researchers conclude.

Clinical Topics: Invasive Cardiovascular Angiography and Intervention

Keywords: TCT20, Transcatheter Cardiovascular Therapeutics, Percutaneous Coronary Intervention, Angioplasty, Balloon, Coronary

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