Biomechanical Mechanisms and Multicenter Clinical Validation of Scoring Balloon–Induced Plaque Modification

Abstract The traditional balloon (TB) provides insufficient plaque modification in arterial stenosis, while the mastoid-structured scoring balloon (SB) has been proposed to strengthen the dilatation effect. However, the underlying biomechanical mechanisms and adequate clinical evidence remain lacking, limiting their widespread adoption. Here, finite element methods were used to assess the effect of lumen dilation and stress distribution across various arterial stenosis (30-70%), followed by in vitro validation. A clinical trial in nine centers was also conducted in 122 patients (40 in the TB group and 82 in the SB group) with average coronary artery stenosis of 81.90% (TB) and 89.99% (SB). The simulation results demonstrated that, compared with TB, SB achieved a greater lumen volume (increased by > 3.2%) with improved uniformity following dilatation. The mastoid design of SB generated average plaque peak stresses at least 15% higher than those of TB, while stresses on the media and adventitia remained <0.11 MPa. Clinically, SB resulted in a lower post-procedural stenosis rate compared with TB (36.9% vs. 66.4%, P < 0.0001). These findings demonstrate that mastoid-structured SB enhances localized biomechanical interactions to achieve more effective plaque modification while preserving vessel safety, supporting their potential as an improved lesion-preparation strategy for arterial stenosis.