Endologix has announced results from a pooled analysis of the DETOUR1 and DETOUR2 studies evaluating percutaneous transmural arterial bypass (PTAB) with the Detour system.
The Detour system offers a novel approach to treating complex peripheral arterial disease (PAD), enabling physicians to bypass lesions in the superficial femoral artery (SFA), by using conduits routed through the femoral vein via a transmural passage, to restore blood flow to the leg. This approach is effective for patients with long lesions (20–46cm in length).
Data were aggregated from DETOUR1 and DETOUR2, both of which were prospective, single-arm, multicenter, international studies. Inclusion criteria and prespecified endpoints were similar. Both studies utilized imaging core lab and independent adverse event adjudication. Endpoints included freedom from major adverse events (MAEs) through 30 days, symptomatic deep vein thrombosis (DVT), and length of stay. For the pooled analysis, primary patency was defined as freedom from target vessel revascularization (TVR).
The results from the 275 pooled patients were presented at VIVA 2023 (Oct. 30–Nov. 2) in Las Vegas by one of the study’s principal investigators, Sean Lyden, MD, chair of vascular surgery at the Cleveland Clinic in Cleveland, Ohio.
The presented results included the following:
- Primary patency, defined as freedom from TVR, was 79.1% at one year and 68.1% through two years
- Freedom from MAEs through 30 days was 97.8%
- Clinical success rate was 92.9%, 96%, and 95.3% at 30 days, one year and two years, respectively
- Symptomatic DVT was 3.3% and pulmonary embolism (PE) rate was 0%, respectively through the two-year time point
- Average length of hospital stay was 1.3 days.
- Ninety-four percent of the patients had chronic total occlusions of the SFA, with a mean lesion length of 31.6cm
“These results not only demonstrate the clinical utility of this therapeutic strategy in managing long complex femoropopliteal lesions but also highlight that PTAB with the Detour system achieves similar results to open surgical prosthetic femoropopliteal bypass without the need for general anesthesia, long length of stay, and high rate of complications. We eagerly await more comprehensive data from broader real-world settings to further corroborate these findings,” stated Lyden.