A fully percutaneous bypass system using the femoral vein as a conduit was safe and effective in patients with long superficial femoral artery lesions at 12 months, according to new data from the DETOUR I study.
As Cardiology Today’s Intervention previously reported, 30-day and 6-month results of the DETOUR I trial of the PQ Detour procedure (PQ Bypass), a percutaneous technique in which revascularization is performed via modular stent graft bypass using the femoral vein as a conduit, showed the procedure was associated with high rates of patency, procedural success and improvement in Rutherford class.
Dainis Krievins, MD, PhD, professor of vascular surgery and director of the Institute of Research at Pauls Stradins Clinical University Hospital in Riga, Latvia, presented 12-month results at the Society for Vascular Surgery Vascular Annual Meeting.
The 77 patients in the study population (mean age, 64 years; 83% men) had 81 lesions treated (mean length, 37.1 cm; 96% chronic total occlusions, 67.5% with severe calcification). The mean ankle-brachial index was 0.64 and 92.2% of patients were Rutherford class 3, with the remainder being class 4 or 5.
Technical success was 98.8%, according to the researchers.
At 12 months, the rate of primary patency was 72.5%, the rate of primary-assisted patency was 78% and the rate of secondary patency was 93.8%, Krievins said during a presentation.
He said freedom from major adverse events at 12 months was as follows:
- freedom from deep vein thrombosis, 97.5%;
- freedom from death, 98.7%;
- freedom from amputation, 100%;
- freedom from acute limb ischemia, 98.8%; and
- freedom from target lesion revascularization, 78.8%.
Ninety percent of patients had improvement of at least two Rutherford classes at 12 months (P < .0001), and mean ankle-brachial index improved to 0.92, Krievins said.
The procedure showed “excellent durability in long, challenging occlusive lesions,” Krievins said during the presentation. “Fully percutaneous bypass is a promising endovascular alternative for complex femoropopliteal disease.”
The system is not yet approved for commercial use in the United States. It received a CE mark for commercial use in Europe in February 2017. Krievins noted the DETOUR II investigational device exemption trial is currently enrolling patients. – by Erik Swain
Krievins D, et al. S8: Scientific Session 8. Presented at: Society for Vascular Surgery Vascular Annual Meeting; June 20-23, 2018; Boston.
Disclosure: Krievins reports he has consulted for Endologix and Lombard Medical.