Effectiveness of intra-arterial manometry in guiding femoral popliteal stent implantation: a prospective randomized controlled trial.

ABSTRACT

BACKGROUND: Femoropopliteal artery occlusion is a prevalent peripheral arterial disease, and endovascular therapy has become the preferred treatment. Accurate assessment of balloon dilation efficacy is crucial for determining the necessity for subsequent stent implantation. This study aims to investigate the use of interlesion arterial pressure gradients as a novel approach to assess balloon dilation efficacy and guide stent implantation decisions. METHODS: A prospective, randomized, controlled trial was conducted on 100 patients with femoropopliteal artery occlusion. Patients were randomized into a control group (n=50) and an experimental group (n=50). Stent implantation was performed in the control group according to standard indications, while the experimental group underwent stent implantation only if the mean arterial pressure gradient exceeded 10 mmHg or fractional flow reserve (FFR) fell below 0.85. Post-intervention, pressure measurements and angiography were used to evaluate residual stenosis, dissection, and pressure gradients. RESULTS: Lesions were categorized into stent-indicated and non-indicated groups. In the non-stent-indicated lesions, the experimental group demonstrated significantly higher patency rates for lesions with pFFR < 0.85 or ΔP > 10 mmHg compared to the control group (92.9% vs. 50.0%, P=0.039). There was no significant difference in patency rates between the experimental and control groups for stent-indicated lesions. CONCLUSION: Combining pressure measurement with angiography provides a more precise evaluation of balloon dilation efficacy and stent implantation indicators in femoropopliteal artery occlusive disease. Further research is needed to establish optimal pressure threshold values and refine treatment guidelines.