Heart Lung Circ. 2026 Sep 3:S1443-9506(26)00395-1. doi: 10.1016/j.hlc.2026.03.076. Online ahead of print.
ABSTRACT
BACKGROUND & AIMS: Although previous meta-analyses have compared limus-based coated balloons (LCB) and paclitaxel-coated balloons (PCB), an updated evaluation of safety and efficacy is needed due to recent randomised controlled trials (RCTs). We aimed to re-evaluate the safety and efficacy of LCB and PCB.
METHODS: We conducted a systematic search of randomised controlled trials (RCTs) up to October 2025. The primary outcome was target lesion revascularisation (TLR); secondary outcomes included clinical and angiographic endpoints. Pooled relative risk (RR) and mean difference (MD) with 95% confidence intervals (CI) were calculated using random-effects models.
RESULTS: Ten RCTs with 1,463 patients and 1,434 lesions were included in the analysis. LCB was comparable with PCB in TLR (RR 1.14; 0.83-1.58; p=0.42), major adverse cardiovascular events (RR 0.98; 95% CI 0.64-1.48; p=0.91), myocardial infarction (RR 1.22; 95% CI 0.47-3.17; p=0.69), all-cause mortality (RR 1.04; 95% CI 0.40-2.70; p=0.94), cardiac death (RR 0.73; 95% CI 0.17-3.22; p=0.68), and target vessel myocardial infarction (RR 0.71; 95% CI 0.28-1.84; p=0.49). Angiographic follow-up showed comparable results between LCB and PCB evaluated from binary restenosis (RR 1.33; 95% CI 0.87-2.05; p=0.19), late lumen loss (MD 0.10; 95% CI -0.00 to 0.21; p=0.05), diameter stenosis (MD 2.94; 95% CI -0.81 to 6.69; p=0.12), minimal lumen diameter (MD -0.09; 95% CI -0.18 to 0.05; p=0.30).
CONCLUSIONS: In the pooled RCT data to 12 months, we found no statistically significant differences between LCB and PCB for major clinical endpoints. However, angiographic endpoints show borderline differences (late lumen loss) and numerically higher binary restenosis with LCB; device heterogeneity and limited follow-up mean that firm equivalence regarding angiographic endpoints should be interpreted with caution.
PMID:42692945 | DOI:10.1016/j.hlc.2026.03.076