Endologix Torus Stent Graft Evaluated to Treat Femoropopliteal Disease in TORUS 2 Study

November 4, 2022—Ehrin J. Armstrong, MD, presented 12-month data from the TORUS 2 study in the third of three Late-Breaking Clinical Trials sessions at the VIVA22 conference held by the VIVA Foundation on October 31 to November 3 in Las Vegas, Nevada.

According to the press release, the TORUS 2 study is a prospective, single-arm, multicenter, international trial. Follow-up was scheduled at 30 days, 6 months, and then annually through year 3. The goal of the TORUS 2 study is to investigate both the safety and effectiveness of the Torus covered stent graft (Endologix) by comparing results to preestablished performance goals.

The primary effectiveness endpoint assesses primary patency at 12 months, which is defined as absence of clinically driven target lesion revascularization (CD-TLR) and recurrent target lesion diameter stenosis > 50% with a peak systolic velocity ratio of > 2.5. The primary safety endpoint is a composite outcome of several major adverse event (MAE) types through 30 days, consisting of all-cause mortality, CD-TLR, and amputation of the target limb.

A total of 188 patients were enrolled and treated with the Torus stent graft system across 34 sites. The mean age is 69.7 ± 8.4 years, 72% are men, and 84% had a Rutherford class ≥ 3. The mean lesion length as assessed by the core lab is 118 ± 44 mm and ranges up to 275 mm.

Additional data presented included:

• 52% had moderate to severe calcification.
• Mean maximum stenosis was 89%, ranging from 50% to total occlusion.
• 36% of patients presented with a total occlusion of the diseased vessel.
• 13% of patients underwent atherectomy.
• The 30-day MAE rate (141 patients) was 1.4% (two CD-TLRs were reported at day 14 and 18).

Technical success was achieved in 100% of patients. Through 1 year, there were four (2.8%) deaths, 24 (17%) CD-TLRs, and one (0.7%) target limb amputation. At 1 year, the freedom from CD-TLR was 75.7%.