DETOUR I: Percutaneous bypass system safe, effective at 24 months
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A fully percutaneous bypass system using the femoral vein as a conduit was associated with high rates of patency and low rates of complications at 24 months in patients with severe peripheral artery disease.
At 24 months, the rate of primary patency of the 77 patients (mean age, 65 years; 83% men) in the single-arm DETOUR I study was 79%, the rate of primary assisted patency was 78% and the rate of secondary patency was 86%, Ehrin J. Armstrong, MD, MSc, FSCAI, director of the VA Eastern Colorado Health Care System and associate professor of medicine at University of Colorado School of Medicine, said during a presentation at VIVA 20.
The patency data “demonstrate excellent durability and compare favorably to existing endovascular technologies’ 12-month data,” Armstrong said during the presentation.
Healio previously reported results from 18 months and earlier.
Regarding safety data, at 24 months, the rate of major adverse events was 17.9%, the rate of mortality was 4.2%, the rate of clinically driven target vessel revascularization was 15.8% — similar to the 15.2% rate at 12 months — the rate of target limb amputation was 1.4% and the rate of target limb deep vein thrombosis was 2.8%, Armstrong said, noting there were no cases of stent fracture.
There were no patients with Rutherford class 0 to 2 at baseline, but at 24 months, 83.3% of patients achieved class 0, 10.3% achieved class 1 and 2.6% achieved class 2, he said.
The patient population had extensive disease, Armstrong said, noting the mean lesion length was 371 mm, 96% had chronic total occlusions and 67% had severe calcification.
The system has a CE mark and has received a breakthrough device designation from the FDA but is not yet approved for commercial use in the United States.
“With the breakthrough device designation and the recent enrollment completion, the DETOUR 2 pivotal study is on track to provide results earlier than expected,” Armstrong said.
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Armstrong EJ, et al. Late-breaking clinical trials. Presented at: VIVA 20; Nov. 6-8, 2020 (virtual meeting).
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