Durability of the DETOUR System for Long and Complex Femoral-Popliteal Lesions: 3-Year Results From the DETOUR2 Trial.

Background: The DETOUR2 Trial assessed the safety and effectiveness of the DETOUR System for percutaneous transmural arterial bypass (PTAB) of the femoral-popliteal (FP) artery. Previously published data reported that the procedure met key safety and effectiveness criteria with durable results through 12 months of follow-up, demonstrating a high technical success rate, few major complications, and maintained patency at rates comparable to surgical bypass. This final report describes the 36-month outcomes. Methods: The DETOUR2 Trial evaluated a novel PTAB technique for treating long-segment (>200 mm) FP lesions in patients with severe peripheral arterial disease (Rutherford Class 3-5) using the DETOUR System (NCT03119233). This international, multicenter, prospective, single-arm trial presents data from participants followed for 36 months. Results: Thirty-two sites enrolled 202 patients, and 200 patients were treated with the DETOUR System. Mean target lesion length was 327.1 ± 61.4 mm. Primary patency through 36 months was 58.2%. Freedom from clinically driven target lesion revascularization through 36 months was 66.8%, and freedom from major adverse limb events was 64.5%. Occurrence of deep venous thrombosis at 36 months was 4.1%, with no pulmonary emboli reported. Conclusions: PTAB with the DETOUR System provides durable results with favorable safety through three years for very long FP lesions exceeding 200 mm in length. DETOUR System patency is comparable to prosthetic FP bypass but with lower complication rates and outperforms traditional endovascular therapy in these long, complex lesions.