Abstract Body (Do not enter title and authors here): Background: Drug-coated balloons (DCBs) are increasingly being used to treat superficial femoral artery (SFA) lesions during endovascular therapy (EVT). However, evaluation of paclitaxel distribution following DCB treatment remains challenging.
Objectives: This study aimed to develop a novel criterion to systematically grade the degree of paclitaxel distribution using non-obstructive general angioscopy and to analyze the clinical factors affecting this criterion.
Methods: Thirteen patients (15 limbs) who underwent EVT for SFA lesions using DCBs were enrolled in this study. Angioscopic observation of the vessel surface was performed before and after DCB treatment. The amount of paclitaxel distribution was systematically graded using the novel Surface observation by Non-obstructive general angioscopy Of Wall drug-distribution (SNOW) grade. Clinical factors were statistically analyzed to determine their relationship with the SNOW grade.
Results: Paclitaxel particles were observed on vessel walls after DCB treatment in all patients. A significant relationship was found between the DCB diameter and the reference lumen diameter, with larger DCBs relative to the lumen resulting in greater drug distribution.
Conclusions: The SNOW grading system, a novel systematic grading system for paclitaxel distribution using angioscopy, was successfully developed. The size of the DCB device relative to the reference distal lumen was identified as a predictor of improved paclitaxel distribution.