One-Year Results from the DETOUR I Trial of the PQ Bypass DETOUR System for Percutaneous Femoropopliteal Bypass.

OBJECTIVE: To evaluate the 1-year safety and effectiveness outcomes associated with the PQ Bypass DETOUR System for the percutaneous bypass of long-segment femoropopliteal occlusive disease. METHODS: This prospective, single-arm, multicenter trial enrolled patients with long-segment femoropopliteal arterial disease. The DETOUR System percutaneously deploys modular stent-grafts to bypass femoropopliteal lesions through a transvenous route. 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. RESULTS: Over a 24-month period, 78 patients (82 limbs) were enrolled. The average core laboratory measured lesion length was 371 +/- 55 mm, 79/82 lesions (96%) were chronic total occlusions, and 55/82 lesions (67%) had severe calcification. The rates of technical and procedural success measured during index procedure were both 96%, with satisfactory delivery and deployment of the device without major adverse events in 79/82 limbs. Through 1 month, there were no deaths or amputations, CD-TVRs occurred in 2/81 limbs (3%), and freedom from major adverse events was 98% (79/81). The 1-year Kaplan-Meier primary, assisted primary, and secondary patency rates were 81% +/- 4%, 82% +/- 4%, and 90% +/- 3%, respectively. The ankle-brachial index increased an average of 0.25 +/- 0.27 between baseline and 1 year (P < 0.001). Through 1 year, the Kaplan-Meier estimates of freedom from stent-graft thrombosis, CD-TVR and MAE were 84% +/- 4%, 85% +/- 4%, and 84% +/- 4%, respectively. At 1 year, the Rutherford category improved in 77/80 limbs (96%), and 65/80 (81%) were asymptomatic. Deep venous thrombosis developed in 2/79 target limbs (3%) through 1 year; both at the femoropopliteal vein level. There were no instances of pulmonary embolism. CONCLUSIONS: The 1-year results from the DETOUR I trial shows the PQ Bypass DETOUR System is a safe and effective percutaneous treatment option for patients with longer, severely calcified, above the knee femoropopliteal lesions. TRIAL REGISTRATION: NCT02471638.