Endologix Detour System for PTAB Evaluated in Pooled Analysis of DETOUR Studies

November 1, 2023—A pooled analysis of the DETOUR1 and DETOUR2 studies evaluated the safety and performance of percutaneous transmural femoropopliteal arterial bypass (PTAB) with the Detour system (Endologix LLC).

PTAB with the Detour system, which consists of the Torus stent graft and the EndoCross crossing device, is intended to construct a percutaneous bypass with the femoral vein as an alternative endovascular approach for long-segment, complex superficial femoral artery (SFA) disease.

Sean Lyden, MD, presented the findings during a late-breaking clinical trial session at VIVA23, the Vascular InterVentional Advances annual vascular education symposium held by The VIVA Foundation on October 30 to November 2 in Las Vegas, Nevada.

According to the VIVA press release, the analysis aggregated data from the two prospective, single-arm, multicenter, international DETOUR studies that evaluated safety and efficacy of the Detour system. Inclusion criteria and prespecified endpoints were similar. Both studies included an imaging core lab and all serious adverse events, including deaths, were adjudicated by a clinical events committee.

Specified endpoints were based on data that were common to both studies.

Safety endpoints included freedom from major adverse events (MAEs) through 30 days, symptomatic deep vein thrombosis (DVT), and amputation rates.

Efficacy endpoints included primary patency, defined as patency obtained without the need for additional/secondary procedures, and freedom from target vessel revascularization (TVR).

A total of 275 patients were enrolled and 273 were treated with the Detour system. Patients’ mean age was 68 years, and 23.7% were female. Comorbidities included hypertension (86.5%), diabetes (44%), and renal insufficiency (9.8%). Mean lesion length was 31.6 cm and included 94% chronic total occlusions and 14% in-stent restenotic lesions.

As summarized in the VIVA press release, the findings from the pooled analysis included the following:

• Freedom from MAEs through 30 days was 97.8%.
• The clinical success rate was 92.9%, 96.0%, and 95.3% at 30 days, 1 year, and 2 years, respectively.
• Primary patency was 69.2%.
• Freedom from TVR was 68.1% through 2 years.
• Freedom from symptomatic DVT was 96.7%.
• The pulmonary embolism rate was 0%.

The DETOUR clinical data demonstrate the clinical utility of this novel therapy in long femoropopliteal lesions, and larger real-world registry data will confirm the generalizability of these findings, reported the VIVA press release.