Optical coherence tomography assessment of dissection following Drug-Coated Balloon treatment in de-novo small vessel disease

Abstract

Abstract Background/Introduction Several studies have shown either favorable or unfavorable effects of dissection following drug-coated balloon (DCB) angioplasty. However, there is no established method to precisely assess the extent of dissection during DCB treatment and the relationship between dissection and late lumen gain (LLG) remains unclear. Purpose The aim of this study is to develop a new method to quantify the dissection and investigate the impact of dissection volume on angiographic outcomes. Methods The present study consisted of patients enrolled in the randomized TRANSFORM-I trial, comparing novel Magic TouchTM sirolimus coated-balloon with SeQuent Please NeoTM paclitaxel coated balloon (PCB) in patients with de-novo small vessel coronary artery disease. One-hundred lesions in 98 patients were investigated with OCT after pre-dilatation to assess the dissection. A customized software (QCU-CMS, Leiden) precisely quantifies the dissection and lumen volumes separated by a common boundary connecting the two edges of the intimal fracture. Quantitative OCT analysis of dissection volume is derived from cross-sectional slices with a thickness of 200 microns. Tissue composition analysis, using OCT-Deep Learning (DL) (Pulse, Shanghai), at the starting site of the dissection was performed to elucidate the mechanisms triggering the dissection. Results The dissection was found in 96% (96/100) of the treated lesions. The median dissection volume was 1.98 (0.57 – 3.89)mm3. The median maximal dissection arc was 113 degree. The tissue composition analysis showed that the dissection occurs at the thinnest site (320 μm) of fibrous intima (83%) (Figure). The 6-month angiographic outcomes of TRANSFORM-I will be presented at the late breaking session by then the mechanistic determinant of late loss and gain will have been examined in details. Conclusions Quantitative OCT analysis of dissection demonstrated that dissection occurs during DCB treatment. Final results with 6-month outcome, relationship between the dissection volume and late lumen loss (LLL) or LLG will be presented at the time of congress.Figure