Minimally invasive PTAB shows promise for patients with complex peripheral arterial disease

New findings from a DETOUR2 substudy show that minimally invasive percutaneous transmural arterial bypass (PTAB) may offer a promising alternative to traditional leg bypass surgery for patients with complex peripheral arterial disease (PAD), even when distal vessel run off is severely limited. Researchers presented the late-breaking data today at the Society for Cardiovascular Angiography & Interventions (SCAI) 2026 Scientific Sessions & Canadian Association of Interventional Cardiology/Association Canadienne de cardiologie d'intervention (CAIC-ACCI) Summit in Montreal.

Patients with severe blockages in the main arteries of the thigh and knee often experience debilitating symptoms such as leg pain, cramping, numbness, or weakness that typically worsen with physical activity. Current treatments include endovascular therapies or surgical bypass. However, without treatment, reduced blood flow can lead to serious complications, including limb loss. A novel alternative to treating long complex SFA disease is the Percutaneous Transmural Arterial Bypass (PTAB) therapy with the DETOUR™ System (Endologix LLC). The System places stents through the femoral vein to create a new pathway for blood to bypass the diseased artery and improve circulation in the leg.

PAD impacts over 200 million people worldwide. In some patients, PAD is so advanced that blood reaches the lower leg and foot through only one of the three arteries that normally supply blood to the area. This single-vessel outflow increases the risk of complications. Results from the prospective, single-arm, multi-center DETOUR2 study show excellent patency for PTAB through three years, but the impact of single-vessel runoff on outcomes was previously unknown.

RODEO-PTAB is the first study to evaluate distal runoff as a predictor of outcomes following PTAB, utilizing three-year data from the DETOUR2 study to determine whether single-vessel outflow affects clinical outcomes. Of the 200 patients who underwent PTAB at 32 sites, 191 had evaluable distal runoff for core laboratory analysis. Among these patients, 33 had single-vessel runoff, and 158 had more than one vessel runoff. A logistic regression model was used to determine the role of distal runoff while accounting for other factors that may influence results, including vessel characteristics and patient medical history. Multivariable models were constructed with and without runoff included as a predictor to assess its independent impact on outcomes. 

The researchers found that the primary patency at one, two, and three years was similar for patients with one vessel runoff (84.4%, 68.0%, and 52.1%) compared to patients with more than one vessel runoff (82.1%, 68.1%, and 59.5%) (p=0.4353). Freedom from clinically-driven target lesion revascularization (CD-TLR) for single-vessel runoff was 93.7%, 77.4%, and 65.1% at each of the first three years versus 86.6%, 75.8%, and 67.2% for those with more than one vessel runoff (p=0.4495). In addition, the proportion of patients without Major Adverse Limb Events (MALE) was 87.7%, 74.2%, and 59.9% for one vessel runoff, compared to 83.1%, 71.6%, and 65.2% for those with more than one. Therefore, after adjusting for baseline predictor variables, the number of runoff vessels was not significant for each outcome.

Findings from this study show that patients with single-vessel runoff maintained excellent patency through three years and can safely benefit from this minimally invasive treatment. These results give operators greater confidence to adopt this technology and treat complex patients who might otherwise be referred for open surgical bypass or have limited treatment options."

Sameh Sayfo, MD, MBA, FSCAI, interventional cardiologist at Baylor Scott & White The Heart Hospital in Plano, Texas

Researchers noted that future studies will include additional real-world analyses as well as evaluating if the post-procedure anticoagulation regimen affects patency.