Two-year data shows IN.PACT Admiral drug-coated balloon gives benefits in peripheral arterial disease- Medtronic

Medtronic announced that new two-year clinical data from the pivotal IN.PACT SFA trial revealed that the IN.PACT Admiral drug-coated balloon (DCB) continues to provide superior clinical outcomes at two years compared to standard balloon angioplasty for the interventional treatment of peripheral arterial disease (PAD) in the upper leg – specifically, in the thigh (superficial femoral arteries or SFA) and behind the knee (popliteal arteries). The IN.PACT SFA trial enrolled 331 patients at 57 sites across Europe and the United States with a mean lesion length of 8.9 ± 4.96 cm. All study subjects were randomised to treatment with either the IN.PACT Admiral DCB or standard balloon angioplasty (percutaneous transluminal angioplasty, or PTA).

Two-year outcomes revealed that the DCB group showed the lowest reported clinically-driven target lesion revascularization (CD-TLR) rate at two years, with 9.1% of patients requiring a repeat procedure, compared to 28.3% of patients in the PTA group. The data also showed a primary patency rate or restoration of blood flow through the treated artery of 78.9% in the DCB group, compared to 50.1% in the PTA group. Results are based on Kaplan-Meier survival estimates for primary patency at two years. The data continue to support an exceptional safety profile, with no major target limb amputations in either group and low blood clot (thrombosis) rates of 1.5% in the DCB group, compared to 3.8% in the PTA group. The data was presented at the 2015 Transcatheter Cardiovascular Therapeutics (TCT) conference.