SAVER ATK Study With Gender Analysis Conducted for Philips’ Stellarex DCB

November 1, 2023—The Stellarex Vascular E-Registry (SAVER) was a multicenter, international, prospective registry designed to assess the safety and efficacy of the Stellarex drug-coated balloon (DCB; Philips) in femoral, popliteal, and/or infrapopliteal arteries in a broad, real-world, claudicant or critical limb ischemia patient population.

Patients with Rutherford clinical classification 2 to 6 who were indicated for percutaneous transluminal angioplasty were enrolled in the study, which was conducted with an individual DCB under normal clinical practice.

Marianne Brodmann, MD, presented findings from SAVER during a late-breaking clinical trial session at VIVA23, the Vascular InterVentional Advances annual vascular education symposium held by The VIVA Foundation on October 30 to November 2 in Las Vegas, Nevada.

The VIVA press released stated that the primary safety outcome was freedom from device- and procedure-related death through 30 days postprocedure and freedom from target limb major amputation and clinically driven target lesion revascularization (CD-TLR) through 12 months.

The primary efficacy outcome was freedom from CD-TLR at 12 months.

Final 12-month outcomes of the above-the-knee (ATK) cohort were evaluated, and a subgroup analysis was performed to assess differences in outcomes according to gender.

The SAVER ATK study demonstrated excellent key safety and efficacy endpoints at 12 months in a real-world population. There were no differences in outcomes when stratified into gender subgroups, demonstrating the strong safety and performance of the Stellarex DCB in both male and female patients, reported the VIVA press release.