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Clinical Trial
. 2024 Jun;79(6):1420-1427.e2.
doi: 10.1016/j.jvs.2024.02.004. Epub 2024 Feb 15.

DETOUR2 trial outcomes demonstrate clinical utility of percutaneous transmural bypass for the treatment of long segment, complex femoropopliteal disease

Sean P Lyden  1 , Peter A Soukas  2 , Ajanta De  3 , Barry Tedder  4 , Jonathan Bowman  5 , Jihad A Mustapha  6 , Ehrin J Armstrong  7 ; DETOUR2 Trial Investigators
Affiliations
Free article
Clinical Trial

DETOUR2 trial outcomes demonstrate clinical utility of percutaneous transmural bypass for the treatment of long segment, complex femoropopliteal disease

Sean P Lyden et al. J Vasc Surg. 2024 Jun.
Free article

Abstract

Objective: Percutaneous transmural arterial bypass (PTAB) using the DETOUR system aims to create a percutaneous, endovascular femoropopliteal bypass for the treatment of long segment, complex superficial femoral and proximal popliteal artery disease. The goal of the DETOUR2 study is to investigate the safety and effectiveness of the therapy in comparison with pre-established performance goals.

Methods: The DETOUR2 investigational device exemption study is a prospective, single-arm, multicenter, international trial of symptomatic peripheral arterial disease patients (Rutherford classes 3-5) undergoing the DETOUR procedure for long segment (>20 cm) superficial femoral artery disease. Prespecified end points included primary safety (composite of major adverse events) at 30 days, and effectiveness (primary patency defined as freedom from restenosis or clinically driven target lesion revascularization) at 1 year.

Results: We enrolled 202 patients at 32 sites with 200 treated with the DETOUR system. The mean lesion length was 32.7 cm, of which 96% were chronic total occlusions (CTO) and 70% were severely calcified. Technical success was achieved in 100% of treated patients. The primary safety end point was met with a 30-day freedom from major adverse event rate of 93.0%. The 1-year primary effectiveness end point was met with 72.1% primary patency at 12 months. Primary-assisted and secondary patency were 77.7% and 89.0%, respectively, at 12 months. The 12 month deep venous thrombosis incidence was 4.1% with no pulmonary emboli reported. Venous quality-of-life scores showed no significant changes from baseline. There was a Rutherford improvement of at least one class through 12 months in 97.2% of patients. The mean ankle-brachial index also improved from 0.61 to 0.95 during this period. There were marked improvements in quality-of-life and functional status measures.

Conclusions: The DETOUR2 study met both the primary safety and effectiveness end points, demonstrating clinical usefulness of this novel therapeutic strategy in long femoropopliteal lesions.

Keywords: Endovascular; Femoropopliteal disease; Long lesions; Lower extremity bypass; Peripheral chronic total occlusions (CTO).

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Conflict of interest statement

Disclosures S.P.L. is a consultant for BD, Boston Scientific, Contego Medical, Cordis, Endologix, Inspire MD, Medtronic, Rapid Medical, Shockwave, Penumbra, and Vivasure; holds stock options in Inspire MD and Centerline Biomedical; is a Board Member for VIVA physicians; participates in research studies for Abbott, Endologix, Surmodics, W. L. Gore & Associates, Terumo Aortic, NIH, Boston Scientific, Merit, Contego Medical, Inspire MD, Reva Medical, Penumbra, Medalliance, and Nectero. P.S. is a consultant for Boston Scientific, Endologix, Shockwave, and W. L. Gore & Associates; participates in research studies from Boston Scientific, Contego Medical, Endologix, Limflow, MedAlliance, Micromedical Solutions, NINDS, Philips, Reflow Medical, Reva Medical, and Shockwave. J.M. has the following disclosures: 2MG-Stock, Angiodynamics-trainer/consultant, Asahi Consultant, patent license agreement, Avenda Stock, AvingerTrainer/consultant, research, Bectin Dickinson Trainer/consultant, Boston Scientific Research, Cagent Vascular Stock, CardioFlow Research, board member/chief medical officer, equity ownership/stock, Cardiovascular Systems, Inc. J.M. is a trainer/consultant, CorVista Stock, Endologix Research, Euphrates Stock, Glift Stock, Iatri Board member/chief medical officer, stock, Ichor/FluidX Stock, Immertec Stock options, Levee Medical Stock, Marvao Medical Research, Medtronic Trainer/consultant, MicroMedical Solutions Board member/chief medical officer, stock option, Philips Trainer/consultant, Reflow Medical Research, stock options Salus Scientific Stock, Soundbite Stock, Terumo Trainer/consultant, Transit Medical Stock, Vantis Vascular Stock, and Versono Research. E.A. is a consultant for Abbott, Boston Scientific, W. L. Gore & Associates, Medtronic, MedAlliance, and Shockwave Medical.

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