Five-year outcomes of the GORE VIABAHN Endoprosthesis for the treatment of complex femoropopliteal lesions from a...

Area of Science:

• Vascular Surgery
• Interventional Cardiology
• Medical Device Evaluation

Background:

• Peripheral artery disease (PAD) significantly impacts patient quality of life.
• Complex femoropopliteal (FP) lesions present treatment challenges.
• Real-world data is crucial for assessing endoprosthesis performance in diverse patient populations.

Purpose of the Study:

• To evaluate the 5-year safety and effectiveness of the GORE VIABAHN Endoprosthesis.
• To assess outcomes in a real-world Japanese patient cohort with complex FP lesions.
• To analyze primary patency, assisted patency, freedom from revascularization, and adverse events.

Main Methods:

• Prospective, multicenter, postmarket surveillance study conducted in Japan (2016-2017).
• Enrollment of 321 symptomatic PAD patients with FP lesions ≥ 10 cm.
• Evaluation of outcomes at 5 years, including patency rates, revascularization, serious adverse events (SAEs), and stent fractures.

Main Results:

• At 5 years, Kaplan-Meier estimated primary patency was 62.4%, primary-assisted patency 74.1%, secondary patency 82.3%, and freedom from target lesion revascularization 75.9%.
• Significant improvement in Rutherford class (2.3 points) was maintained through 5 years.
• Cumulative device/procedure-related SAEs were 19.9%, with most occurring within the first year; no stent fractures were observed.

Conclusions:

• The GORE VIABAHN Endoprosthesis shows clinically acceptable 5-year safety and efficacy for complex FP lesions in Japanese PAD patients.
• The device provides sustained clinical benefit and acceptable safety profile in a real-world setting.
• Findings support the use of this endoprosthesis for challenging femoropopliteal interventions.