IN.PACT AV Access Meets Endpoints in Six-Month Results; Follow-Up Extended to 5 Years

Hollywood, FL (January 23, 2020) -- Robert Lookstein, MD, presented the 6-month results of the IN.PACT AV access trial at the International Symposium on Endovascular Therapy (ISET). This study is the second pivotal drug-coated balloon (DCB) trial that has been performed globally.

“This is the first multicenter prospective randomized controlled trial comparing drug-coated balloons to standard balloon angioplasty that actually met its primary effectiveness endpoint,” he said. Dr. Lookstein was the U.S. principal investigator for the study, which evaluated the safety and efficacy of the IN.PACT AV access balloon in autologous arteriovenous fistulae in the upper extremities. The study is a prospective trial with 30 sites throughout the world.

“We originally had planned for 2-year follow-up, but following the  controversy surrounding DCBs, we have extended follow-up to 5 years,” Dr. Lookstein said.

The randomization scheme of the trial was 1:1, and lesions up to a length of 10 cm were able to be enrolled. The primary effectiveness endpoint was targeted lesion primary patency rates to 6 months, which was defined as freedom from clinically-driven target lesion revascularization (CD-TLR) or access circuit thrombosis measured through 6 months post procedure. The primary safety endpoint was freedom from serious adverse events within 30 days.

There were no major demographic differences between the cohorts, though there was a high representation of congestive heart failure. “As you would expect in a patient population representing end-stage renal disease,” explained Dr. Lookstein.

Target lesion length was just under 5 cm, with slightly longer lesion length seen in the experimental group than in the control group. “The dominant lesions were seen in the left arm, and the AV fistulas were very mature, in average ranging over 3 years,” said Dr. Lookstein.

The trial reached its primary endpoint, with 82% primary patency of the target lesion at six months, compared with 59.5% for plain balloon angioplasty. He added, “The safety endpoint was easily met, with no difference between the two groups out to 30 days.”

Dr. Lookstein referenced the surprise and concern of the interventional community and the FDA last year regarding paclitaxel and a possible mortality signal. He continued, “I'm so proud to report that at 12 months, there's absolutely no difference in mortality when IN.PACT AV access was compared to a control, demonstrating the safety of this study compared to plain balloon angioplasty.”

He added, “We saw a 56% reduction in the number of reinterventions required. Superior patency was achieved in both de novo and restenotic lesions at all anatomic subsets that we're studying.”

Regarding the anatomic lesions, he said that although benefits were seen in all areas, the “greatest clinical benefit was seen at the level of the anastomosis and at the cephalic arch. I think we all agree that these are the most challenging anatomic subsets to treat.”

The six-month results on IN.PACT AV Access are being prepared for manuscript submission, he noted, and 12-month results will be presented later in 2020.