Local paclitaxel induces late lumen enlargement in coronary arteries after balloon angioplasty.

Abstract

This study investigated p aclitaxel-induced luminal changes following drug-coated balloon (DCB) angioplasty to treat coronary de novo lesions without additional stenting. DCB-mediated local drug delivery reduces late lumen loss in de novo coronary artery lesions. We performed a retrospective clinical assessment based on a pre-specified quantitative coronary angiography (QCA) protocol. QCA was performed for each centre to assess the primary endpoint late lumen changes, i.e. the difference between in-lesion minimal lumen diameter (MLD) at the routine angiographic follow-up as compared to post-procedural in-lesion MLDs. These MLD changes were compared to corresponding reference vessel diameter changes as an intra-patient control. We evaluated 58 consecutive native coronary artery lesions directly after DCB angioplasty and at a routine target follow-up angiography of 4months by QCA. Target lesion MLD increased significantly within the 4.1±2.1month observation period (1.75±0.55 vs. 1.91±0.55mm, p<0.001, diameter stenosis 33.8±12.3 vs. 26.9±13.8%, p<0.001), while there were no changes in non-target reference vessel diameters (2.33±0.60 vs. 2.34±0.61mm, p=ns). A total of 69% of patients showed luminal enlargement whereas 29% had minor luminal loss. Local application of paclitaxel by DCB angioplasty to native coronary arteries after pre-dilatation without major dissection and recoil leads to late lumen increase.