RODEO-PTAB: PTAB Benefits Independent of Number of Runoff Vessels

RODEO-PTAB, a substudy of the DETOUR2 trial, has demonstrated that percutaneous transmural arterial bypass (PTAB) may offer an alternative to leg bypass surgery in patients with complex peripheral arterial disease (PAD).1

PAD affects >200 million patients worldwide, with some cases so severe that blood reaches the lower leg and foot via only 1 of the 3 arteries normally supplying blood to the area. This condition, known as single-vessel outflow, increases the risk of complications.1

“We looked at driven revascularizations and also amputation, and interestingly enough, there was actually no difference between the 2 cohorts in any of those findings, which is really impressive,” Sameh Sayfo, MD, program director of the Endovascular Intervention Fellowship at the Heart Hospital Baylor Plano and an interventional cardiology and peripheral endovascular specialist at Baylor Scott & White Health, told HCPLive in an exclusive interview. “What that tells us is that, as long as you have a single good vessel runoff all the way to the ankle, this new technology, with the PTAB, is very effective and safe to use.”

DETOUR2 Trial

The original DETOUR2 trial was a prospective, multicenter, international, single-arm clinical investigation evaluating the DETOUR System for percutaneous bypass of long segment femoropopliteal (Trans-Atlantic Inter-Society Consensus D) lesions. Patients were eligible for inclusion if they presented with symptomatic leg ischemia Rutherford-Becker Clinical Category class (RCC) 3-5, Venous Clinical Severity Score (VCSS) of <3, and angiographic evidence of lesion length of >20 cm, among other criteria.2

The primary safety endpoint of the study was freedom from a major adverse event (MAE), which included death, clinically driven target lesion revascularization (CD-TLR), major amputation of the treated limb, symptomatic deep vein thrombosis (DVT), pulmonary embolism, or procedure-related bleeding requiring transfusion or surgery, through 30 days. The primary effectiveness endpoint was primary patency through 12 months.2

A total of 202 patients were treated with the investigational device – of these, 200 were treated with the DETOUR system. Technical success was documented in 100% of treated patients, and the primary safety endpoint was met with a 30-day freedom from MAE rate of 93%. The primary effectiveness endpoint was met with 72.1% primary patency at 12 months. Additionally, patients exhibited a Rutherford improvement of ≥1 class through 12 months in 97% of patients.2

RODEO-PTAB Analysis

RODEO-PTAB specifically examined distal runoff as a predictor of outcomes following PTAB. Using 3-year data from DETOUR2, Sayfo and colleagues investigated the 191 patients with evaluable distal runoff – of these, 33 had single-vessel runoff and 158 had >1 vessel runoff. The team used a logistics regression model to determine the role of distal runoff while taking other potential influencing factors into account.1

Ultimately, Sayfo and colleagues found that primary patency at 1, 2, and 3 years was similar for patients with 1-vessel runoff (84.4%, 68%, and 52.1%) and those with >1 vessel runoff (82.1, 68.1%, and 59.5%) (P = .4353). Freedom from CD-TLR for single vessel runoff was 93.7%, 77.4%, and 65.1% at each of the first 3 years versus 86.6%, 75.8%, and 67.2% for patients with >1 vessel runoff (P = .4459). The proportion of patients with MAE was also similar between both groups.1

Sayfo and colleagues determined that, after adjusting for baseline predictor variables, the number of runoff vessels was not significant for each determined outcome. The team also noted that future studies examining this potential connection, or lack thereof, will include real-world analyses to evaluate if post-procedure anticoagulation regimen effects patency.1

“Even with a sicker patient population who has single vessel runoff, the basis rate was actually very good,” Sayfo said. “That was very surprising and very reassuring – with this technology, the number of the runoffs did not really matter.”

Editors’ Note: Sayfo reports disclosures with Terumo, Surmodics, AngioDynamics, Shockwave Medical, Medtronic, and Imperative Care.

References

1. Sayfo S. Minimally Invasive Percutaneous Arterial Bypass Shows Strong Outcome Regardless of Distal Vessel Flow. SCAI. April 23, 2026. Accessed May 11, 2026. https://www.scai.org/media-center/news-and-articles/minimally-invasive-percutaneous-arterial-bypass-shows-strong-outcome

2. Lyden SP, Soukas PA, De A, et al. DETOUR2 trial outcomes demonstrate clinical utility of percutaneous transmural bypass for the treatment of long segment, complex femoropopliteal disease. J Vasc Surg. 2024;79(6):1420-1427.e2. doi:10.1016/j.jvs.2024.02.004