Two-year results from Medtronic‘s (NYSE:MDT) In.Pact SFA study showed that the drug-eluting balloon was better than conventional balloon angioplasty, researchers said today at the annual Transcatheter Cardiovascular Therapeutics conference in San Francisco.
The 331-patient study randomized subjects 2:1 to either treatment with Medtronic’s In.Pact Admiral DEB or standard angioplasty. The primary efficacy endpoint was primary patency, while the primary safety endpoint was a composite of freedom from device- and procedure-related death after 30 days and freedom from target limb major amputation and clinically-driven target lesion revascularization at 2 years.
Results from the study, which was also published in the Journal of the American College of Cardiology, showed that the DEB-treated arm had a much higher primary patency rate (78.9% compared with 50.1% for the control arm). Freedom from CD-TLR was 91.0% for the DEB group and 72.2% for the standard angioplasty group. For the 2-year composite safety endpoint, the DEB group showed an 87.4% rate, compared with a 69.8% rate for the control group. There were no device- or procedure-related deaths or major amputations in either group at 2 years, although mortality unrelated to the device or procedure was higher in the In.Pact Admiral group.
“The 2-year data from In.Pact SFA demonstrates the continued superiority of drug-coated balloons for treating patients with superficial femoral artery disease compared to percutaneous transluminal angioplasty,” lead investigator Dr. John Laird Jr., of the UC Davis Medical Center, said in prepared remarks. “With a sustained durability and no late catch-up after two years, this has the potential to drive a paradigm shift in how we treat SFA disease.”
“The In.Pact Admiral DEB’s cadence of strong clinical data not only demonstrates the therapy’s sustained durability, but also our deep-rooted commitment to providing innovative technologies that advance healthcare together in partnership with clinicians worldwide,” added Medtronic vice president Brian Verrier. “We look forward to unveiling additional new data on the device at VIVA.”