Gore Viabahn for In-Stent Restenosis in the SFA Evaluated at 3-Years in Postmarket RELINE MAX Study

November 4, 2022—Long-term, 36-month outcomes were reported from RELINE MAX, the postmarket approval study of the Viabahn endoprosthesis (Gore & Associates) for the treatment of bare-metal in-stent restenosis (ISR) in the superficial femoral artery (SFA).

RELINE MAX was a prospective, single-arm international study that enrolled patients at 23 sites from October 2015 to April 2018.

Peter A. Soukas, MD, presented the findings in the second 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.

As summarized in the VIVA Foundation press release, patients with ≥ 50% ISR or occlusion in the SFA, Rutherford category 2 to 5 disease, and ≥ 1 patent runoff vessel were eligible for inclusion in the RELINE MAX study.

The primary effectiveness endpoint was primary patency at 12 months. The primary safety endpoint was rate of device- or procedure-related serious adverse events (SAEs) at 30 days.

A total of 108 patients were enrolled in the study; 86 patients were included for analysis through 3 years. Of these patients, characteristics included mean age of 70.9 ± 10.4 years and 48.8% were female.

Mean core lab–reported lesion length was 12.4 ± 6.92 cm (29.1% occluded lesions); 10.5% of patients presented with chronic limb-threatening ischemia; and 81.9% of lesions were Tosaka class II and III.

The investigators found that acute procedural success was 98.8%. Freedom from device- or procedure-related SAEs was 96.5% through 30 days.

Dr. Soukas reported the following results:

• At 1 year, primary, primary-assisted, and secondary patency rates were 74.7%, 80.4%, and 89.4%, respectively.
• Freedom from target lesion revascularization was 84.8%, 74.6%, and 65.0% at 1, 2, and 3 years, respectively.
• No major amputations or device fractures occurred through 3 years per core lab assessment.
• At 3 years, 80.4% of patients had ≥ 1 Rutherford category improvement.

Additionally, the press release noted that more recent studies from Japan using the Viabahn device in de novo SFA lesions suggest high primary patency rates with use of intravascular ultrasound (IVUS) to avoid oversizing the device by 20%.

A prospective evaluation of stent grafting for the treatment of femoropopliteal ISR utilizing IVUS and best practices is needed to improve the long-term outcomes of patients with long, complex femoropopliteal ISR, stated the VIVA Foundation press release.