Abstract
BACKGROUND: It remains unclear whether drug-coated balloons (DCBs) and drug-eluting stents are comparable in the treatment of coronary artery disease (CAD) and whether limus versus paclitaxel DCBs yield similar clinical outcomes. We aimed to assess the clinical efficacy of limus and paclitaxel DCBs in patients with CAD through a network meta-analysis.
METHODS: We comprehensively searched multiple databases for randomized controlled trials comparing the following 4 strategies: limus DCB, paclitaxel DCB, second-generation or newer drug-eluting stent, and plain old balloon angioplasty. The primary outcome was trial-defined major adverse cardiovascular events (MACEs), typically a composite of death, myocardial infarction, and target lesion revascularization. Secondary outcomes included individual components of MACE. We performed subgroup analyses for in-stent restenosis, small-vessel (<3 mm) CAD, and other de novo CAD, such as large vessel and ST-segment-elevation myocardial infarction.
RESULTS: We identified 39 randomized controlled trials including 10 219 patients. There was no significant difference in MACE between limus and paclitaxel DCBs (relative risk, 1.22 [95% CI, 0.86-1.73]). There were no significant differences in MACE between limus or paclitaxel DCB and second-generation or newer drug-eluting stents. Plain old balloon angioplasty had an increased risk of MACE compared with others. These results were consistent across subgroup analyses for in-stent restenosis, small-vessel CAD, and other de novo CAD.
CONCLUSIONS: No significant differences were observed in MACE or its components between limus and paclitaxel DCBs, albeit with limited statistical power. Furthermore, DCB and second-generation or newer drug-eluting stents yielded similar outcomes though power was limited, especially for other de novo CAD.
REGISTRATION: URL: https://www.crd.york.ac.uk/PROSPERO/; Unique identifier: CRD420250654276.