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SVS-VESS Scientific Session @ VAM: Session 2

VESS16 - Durability of Percutaneous Bypass for Treatment of Femoropopliteal Disease: Two-year Outcomes of the DETOUR-2 Study

Wednesday, June 14, 2023
4:02 PM – 4:09 PM ET

    Submitting & Presenting Author(s)

  • Sean P. Lyden, MD

    Chairman
    Department of Vascular Surgery at Cleveland Clinic’s Sydell and Arnold Miller Family Heart, Vascular & Thoracic Institute
    Cleveland, Ohio

    • Co-Author(s)

  • JM

    Jihad Mustapha

    Advanced Cardiac & Vascular Amputation Prevention Centers
    Grand Rapids, Michigan

Objectives: The DETOUR System is a novel percutaneous femoropopliteal bypass-like procedure for PAD patients with complex disease including long lesions, heavy calcification, and CTO’s. The Detour System uses standard endovascular techniques with a novel crossing device and stent graft to create a percutaneous femoropopliteal bypass. We report two-year safety and effectiveness results of this innovative percutaneous revascularization.

Methods: The DETOUR-2 IDE study is a prospective, single-arm, multi-center center trial across 36 sites for lesions >20 cm long in the femoropopliteal segment with Rutherford Stage 3-5 disease. Follow-up visits were conducted at 30 days, 6 months, and annually through 3 years. The primary safety endpoint was freedom from MAEs through 30 days. The primary effectiveness endpoint was patency through 12 months (absence of CD-TLR and recurrent target lesion diameter stenosis >50%). The 24-month assessments include major adverse events composed of mortality, CD-TLR, and index limb amputation and venous events.

Results: 202 patients were enrolled and treated with the DETOUR System; 96% had CTO. Mean lesion length was 327+/-61 mm. Primary clinical success rate at 2 years was 94.9%. Primary assisted patency through 24 months was 68.8%. The rate of CD-TLR through 2 years for DETOUR patients was 24.5%. At 2 years, major index limb amputation rate is 1.6%. All-cause mortality through 24 months was 5.1%. Occurrence of DVT and PE through 2 years is 4.1% and 0%, respectively. Overall Villalta scores decreased (-0.9 ± 3.45), while VCSS parameters largely remained unchanged through follow up.

Conclusions: The DETOUR-2 24-month outcomes demonstrate durable treatment effect and clinical utility of this novel therapeutic strategy in complex femoropopliteal lesions. These longer-term results suggest that the percutaneous bypass system is a safe and acceptable treatment option for patients with symptomatic PAD patients with similar results to open surgical prosthetic femoropopliteal bypass.