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Taste of Boston
Taste of Boston

P7: Plenary 7/Late Breaking Abstracts

RS25 - Expanding the Toolbox for Complex Femoropopliteal Lesions: Percutaneous Transmural Arterial Bypass Outcomes in Patients with In-Stent Restenosis

Saturday, June 13, 2026
7:28 AM - 7:35 AM ET
Location: Hynes CC, Third Level, Ballroom A

    Presenting Author only(s)

  • Peter A. Schneider, MD

    Professor of Surgery
    University of California, San Francisco
    SAN FRANCISCO, California

    • Submitting Author only(s)

  • AS

    Ami Sood

    Sr. Director Clinical & Medical Affairs
    Endologix

Objectives: Percutaneous Transmural Arterial Bypass (PTAB) provides a novel endovascular option to treat complex femoropopliteal disease, including long lesions, heavy calcification, in-stent restenosis (ISR), and chronic total occlusions, which are often features of challenging endovascular cases. This post hoc subgroup analysis of the DETOUR2 IDE Study, which included 17% of patients with in-stent restenosis (ISR), is the first report of outcomes for this group of patients within the study.

Methods: The DETOUR2 IDE study was a prospective, single-arm, multi-center trial (NCT03119233) completed at 36 centers in the US and Europe. Key inclusion criteria included requirements for long femoropopliteal lesions (≥20 cm) and Rutherford Category 3-5 symptoms. Follow-up visits were conducted at 30 days (d), 6 months (mo), and annually through 3 years (yr). Baseline lesion characteristics including presence of ISR were assessed and reported by an independent core laboratory.

Safety and effectiveness measures through 3yr were compared using Kaplan-Meier estimates. Primary patency was defined as patency that is obtained without the need for additional or secondary surgical or endovascular procedures.

Results: A total of 200 subjects were enrolled as modified Intent-to-Treat (mITT) group, with 35 participants having an ISR lesion. Primary patency in the ISR cohort was 85.1%, 66.9%, and 53.0% and was similar to those without ISR (81.0%, 67.6%, and 59.3%) at 1, 2, and 3yr respectively. Freedom from amputation through 3 years in the ISR cohort was 97.1% compared with those other lesion types at 98.8%.

Freedom from total occlusion trended lower in subjects with ISR; freedom from total occlusion was 72.3% in ISR subjects compared with 86.4% in those without ISR. Despite this trend, secondary patency was excellent in both groups, with most subjects (87.4% vs 98.1% in the ISR and non-ISR cohort, respectively) maintaining blood flow through 3 years.

Conclusions: Patients with ISR were treated in the DETOUR2 IDE study successfully, with comparable outcomes to non-ISR subjects. The ISR cohort was more likely to develop total occlusion, which were managed through re-intervention. Routine surveillance, as recommended for all patients receiving endovascular reinterventions, may be particularly helpful for patients with initial ISR to ensure long-term patency.