April 7, 2020
One-Year Outcomes Reported for PQ Bypass' Detour System to Treat Femoropopliteal Lesions
April 7, 2020—The 1-year safety and effectiveness results from the DETOUR I trial of the Detour system (PQ Bypass, Inc.) for percutaneous femoropopliteal bypass were published by Dainis K. Krievins, MD, et al online in Journal of Vascular Surgery (JVS). The Detour system percutaneously deploys modular stent grafts to bypass femoropopliteal lesions through a transvenous route.
From the 1-year DETOUR I results, the investigators concluded in JVS that the PQ Bypass Detour system is a safe and effective percutaneous treatment option for patients with longer, severely calcified, above-the-knee femoropopliteal lesions.
According to the investigators, this prospective, single-arm, multicenter trial enrolled patients with the long-segment femoropopliteal arterial disease who were treated with the Detour system. Eligible patients included those with Trans-Atlantic Inter-Society Consensus C and D lesions > 100 mm in length.
The primary safety endpoint was the major adverse event (MAE) rate through 1 month, defined as the composite of death, clinically driven target vessel revascularization (CD-TVR), or major amputation. The primary effectiveness endpoint was stent graft patency through 6 months, defined as freedom from stenosis ≥ 50%, occlusion, or CD-TVR.
As summarized in JVS, the trial enrolled 78 patients (82 limbs) over a 24-month period. The average core laboratory-measured lesion length was 371 ± 55 mm, 79 of 82 (96%) lesions were chronic total occlusions, and 55 of 82 (67%) lesions had severe calcification.
The investigators reported that at the index procedures:
- Rates of both technical and procedural success were 96%
- Delivery and deployment of the device was satisfactory without major adverse events in 79 of 82 limbs
At 1 month:
- No deaths or amputations
- CD-TVRs occurred in two of 81 (3%) limbs
- Freedom from major adverse events was seen in 79 of 81 (98%)
At 1 year:
- Kaplan-Meier primary, assisted primary, and secondary patency rates were 81% ± 4%, 82% ± 4%, and 90% ± 3%, respectively
- Ankle-brachial index increased an average of 0.25 ± 0.27 between baseline and 1 year (P < .001)
- Kaplan-Meier estimates of freedom from stent graft thrombosis, CD-TVR, and MAE were 84% ± 4%, 85% ± 4%, and 84% ± 4%, respectively
- Rutherford category improved in 77 of 80 (96%) limbs, and 65 of 80 (81%) were asymptomatic
- Deep venous thrombosis developed in two of 79 (3%) target limbs both at the femoropopliteal vein level
- No instances of pulmonary embolism