Limus- Versus Paclitaxel-Coated Balloons for Coronary In-Stent Restenosis: Meta-Analysis of Randomized Controlled Trials Publisher Pubmed



Babaei M ; Fallahtafti P ; Rashedi S ; Barati S ; Khalilipur E ; Firouzi A ; Shishehbor MH ; Sadeghipour P
Source: Cardiovascular Intervention and Therapeutics Published:2026

Abstract

Drug-coated balloons (DCB) are increasingly utilized for treating in-stent restenosis (ISR), yet the comparative efficacy of limus-coated balloons (LCBs) versus paclitaxel-coated balloons (PCBs) remains uncertain. The aim of this study is to compare the clinical and angiographic outcomes of LCB versus PCBs in treating ISR. We searched PubMed, Embase, and ClinicalTrials.gov through July 2025 for RCTs comparing LCBs versus PCBs in patients with ISR. The primary outcome was late lumen loss (LLL). Secondary outcomes included percentage diameter stenosis (%DS), minimal lumen diameter (MLD), and binary restenosis at 6–12 months and target lesion revascularization (TLR), target lesion failure (TLF), target vessel myocardial infarction, cardiac death, and stent thrombosis at 12 months. Mean differences (MDs) were calculated for continuous outcomes and relative risks (RRs) for binary outcomes. Six RCTs with 968 patients (512 LCB, 456 PCB) showed statistical non-inferiority for LLL with an MD of 0.06 mm (–0.07 to 0.18, P for non-inferiority < 0.001, I2 = 65%) based on the prespecified 0.20 mm margin. No significant differences were found in other angiographic outcomes: MD of 3.13 (–1.07 to 7.33, p = 0.14) for %DS, − 0.07 (–0.17 to 0.03, p = 0.15) for MLD, and RR of 1.32 (0.86 to 2.03, p = 0.21) for binary restenosis. Clinical outcomes were comparable with a non-significant trend toward higher TLR (RR: 1.23 [0.87 to 1.75], P = 0.24) and TLF (1.19 [0.88 to 1.63], P = 0.26) in LCB arm. LCBs are statistically non-inferior to PCBs for ISR treatment regarding late lumen loss, with considerable heterogeneity. Given the inconclusiveness of angiographic outcomes and marginally better clinical outcomes in PCBs, the conduct of larger trials seems necessary. © The Author(s) under exclusive licence to Japanese Association of Cardiovascular Intervention and Therapeutics 2025.