A novel angiographic index for predicting the efficacy of drug-coated balloons in small vessels

Abstract

Background: The drug delivery efficiency of drug-coated balloons (DCBs) in de novo coronary artery disease is correlated with atherosclerotic plaque characteristics. It remains to be elucidated whether plaque composition and vulnerability can affect the efficacy of DCBs.

Aims: This study aimed to explore the association between a novel angiography-based radial wall strain (RWS) measurement for plaque vulnerability and DCB efficacy in de novo small vessel disease (SVD).

Methods: This study is a post hoc analysis of 266 SVD lesions in 260 patients treated with a paclitaxel‐coated balloon or plain old balloon angioplasty (POBA) from the PEPCAD China SVD study. The baseline maximum RWS (RWS_max) ≥13% was selected as the cutoff value for vulnerable plaques. The primary outcome was in-segment late lumen loss (LLL) at 9-month follow-up.

Results: A total of 152 and 72 lesions in the DCB and POBA groups, respectively, completed the 9-month angiographic follow-up. In the DCB group, lesions with RWS_max ≥13% had higher in-segment LLL (0.24±0.53 mm vs 0.05±0.16 mm; p=0.0009), greater binary restenosis (14.9% vs 1.9%; p=0.0040) and more target lesion failure (10.2% vs 1.6%; p=0.022) than those with RWS_max <13%. Among all the lesions with RWS_max ≥13%, no significant difference was observed in in-segment LLL (0.24±0.53 mm vs 0.32±0.48 mm; p=0.49) between the DCB and POBA groups.

Conclusions: Angiographically derived RWS has the potential to predict the angiographic and clinical outcomes of DCB treatment for de novo SVD (PEPCAD China SVD study; ClinicalTrials.gov: NCT03625830).