Low-dose versus regular-dose paclitaxel-coated balloons for de novo coronary lesions: the ALLIANCE registry

Drug-coated balloons (DCBs) are widely used in clinical practice; however, the clinical impact of differences between DCB platforms, including paclitaxel dose, remains uncertain. This study compared the clinical efficacy and safety of low-dose (LD) versus regular-dose (RD) paclitaxel-coated balloons (PCBs) for de novo coronary lesions using data from the ALLIANCE registry, a prospective, multicenter, all-comers study. Patients treated with an LD-PCB (AGENT) or RD-PCB (SeQuent Please Neo) were compared using propensity score matching at a target LD-to-RD ratio of 2:1. The primary endpoint was 1-year target lesion failure (TLF), defined as a composite of cardiac death, target vessel myocardial infarction, and clinically driven target lesion revascularization (cd-TLR). Among 1,568 patients included in this analysis, propensity score matching yielded 784 patients in the LD-PCB group and 419 in the RD-PCB group. At 1 year, the incidence of TLF was 5.1% in the LD-PCB group and 3.8% in the RD-PCB group ( p = 0.33). Kaplan-Meier analyses showed no significant between-group differences in TLF or its individual components. In this propensity score-matched registry analysis, LD-PCBs and RD-PCBs were associated with no statistically significant difference in 1-year TLF. These findings are exploratory and hypothesis-generating and do not establish equivalence between the two platforms. Low-dose vs. regular-dose paclitaxel-coated balloons for coronary artery disease. The 2:1 propensity-score-matched population consisted of 784 patients in the LD-PCB group and 419 patients in the RD-PCB group, achieving a well-balanced baseline characteristics. There were no significant differences in the incidence of primary or key secondary endpoints between the two groups. ACS=acute coronary syndrome, cd-TLR=clinically driven target lesion revascularization, DM=diabetes mellitus, LD=low dose, PAD=peripheral artery disease, PCB=paclitaxel-coated balloon, PCI=percutaneous coronary intervention, RD=regular-dose, TLF=target lesion failure.