Author + information
- Jihad Mustapha1
Unlike short-segment femoropopliteal disease, where percutaneous revascularization is durable, long-segment disease presents unique challenges and an optimal first-line therapy has yet to be recommended. Percutaneous revascularization is less traumatic compared to open surgical bypass but lacks durability in long-segments. Open surgical bypass is the gold standard for durability in long-segment disease, but is associated with increased morbidity, and longer length of stay and recovery times. Percutaneous femoropopliteal bypass is a newly developed procedure that combines the safety and minimally invasive benefits of percutaneous revascularization with the long-term durability of surgical bypass. The DETOUR I trial evaluates the safety and efficacy of the PQ Bypass DETOUR procedure in long-segment femoropopliteal disease.
This is a prospective, multi-center, non-randomized, single-arm trial. Primary 6-month safety endpoint Major Adverse Events (MAE); defined as death, TVR, and major amputation of the target limb. Primary performance endpoint primary patency at 6 months; defined as PSVR of ≤ 2.5. Proprietary devices are used to create anastomoses between the artery and vein at the proximal and distal margins of the SFA occlusion. Proprietary stent grafts are deployed in continuous overlapping fashion to create an SFA to popliteal artery bypass within the femoral vein.
60 subjects were enrolled and treated. Mean age was 64 ± 9 years (68/68). The DETOUR procedure achieved technical success in 98.3% (59/60) of cases. Independent Core Lab-assessed screening CTAs indicate a mean lesion length of 28.6 ± 5.1 cm (60/60), with 96.7% (58/60) chronic total occlusions. The primary safety and efficacy endpoints were met at 3.4% MAE at 30 days with 0 cases of DVT and 84.7% primary patency at 6 months. At 6 months, MAE was 10.2% and 91.2% of subjects had a ≥ 2 class improvement in Rutherford Becker Class. Longer-term data presented on date of podium presentation if accepted.
The novel DETOUR procedure can be performed safely and effectively. It may be an important step forward in establishing a new standard of care for patients with long-segment femoropopliteal disease.
ENDOVASCULAR: Peripheral Vascular Disease and Intervention