DETOUR2 Final Results Evaluate Endologix Detour for PTAB to Treat Complex Femoropopliteal Disease

November 5, 2024—The final results from the DETOUR2 study evaluated the durability of percutaneous transmural arterial bypass (PTAB) using the Detour System (Endologix) for the treatment of complex femoropopliteal disease.

Sean P. Lyden, MD, presented the DETOUR2 findings in the third late-breaking clinical trials session at VIVA24, the 22nd annual Vascular InterVentional Advances annual vascular education symposium held by The VIVA Foundation on November 3-6 in Las Vegas, Nevada.

According to the VIVA24 press release, PTAB with the Detour System is a novel endovascular procedure to treat complex femoropopliteal disease, including long lesions, heavy calcification, and chronic total occlusions (CTOs). The Detour System uses standard endovascular techniques with a unique crossing device and stent graft to create a percutaneous femoropopliteal bypass.

Dr. Lyden reported on the final 3-year safety and effectiveness results of this innovative percutaneous revascularization.

The DETOUR2 investigational device exemption study is a prospective, single-arm, multicenter trial evaluating lesions > 20 cm in the femoropopliteal segment in patients with Rutherford class 3 to 5 disease across 36 sites.

Follow-up visits were conducted at 30 days, 6 months, and annually through 3 years. The 36-month outcomes include clinically driven target lesion revascularization (CD-TLR) and primary patency, defined as the need for additional or secondary surgical or endovascular procedures. Venous events were also assessed.

Among the 202 patients enrolled and treated with the Detour System, 96% had CTOs. Mean lesion length was 327 ± 61 mm. Primary patency through 36 months was 58.2%.

At VIVA24, Dr. Lyden stated that through 3 years, the freedom from CD-TLR rate for Detour patients was 66.8%; the major index limb amputation rate was 1.5%; and the all-cause mortality rate was 8.9%. Occurrence of deep vein thrombosis and pulmonary embolism through 3 years was unchanged from 2 years, at 4.1% and 0%, respectively. Overall Villalta scores and Venous Clinical Severity Score also remained unchanged from baseline through 3 years.

The 36-month outcomes from the DETOUR2 trial demonstrate the clinical utility and safety of this novel therapeutic strategy in complex femoropopliteal lesions. These long-term results suggest that PTAB with the Detour System achieves similar results to open surgical prosthetic femoropopliteal bypass. PTAB provides a standardized technique with durable outcomes when open surgical revascularization is not viable or traditional endovascular therapy has failed.

Additional data from the PTAB1 postmarket, real-world registry will confirm the application of these findings to a wider population, advised the VIVA24 press release.