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Efficacy of Sirolimus Versus Paclitaxel-Coated Balloons for Coronary Revascularization: An Updated Meta-Analysis with
Matthew A Wijayanto1, Christopher D Tristan1, Erlangga M Kynaya1
1Faculty of Medicine, Universitas Sebelas Maret, Surakarta, Central Java, Indonesia.
Insights
Sirolimus-coated balloons (SCB) and paclitaxel-coated balloons (PCB) show similar effectiveness in percutaneous coronary intervention. This meta-analysis found no significant differences in major clinical or angiographic outcomes between SCB and PCB for coronary revascularization.
Area of Science:
- Cardiovascular Medicine
- Interventional Cardiology
- Biomaterials Science
Background:
- Drug-coated balloons (DCBs) are increasingly utilized for coronary revascularization.
- Uncertainty exists regarding the comparative efficacy of sirolimus-coated balloons (SCB) versus paclitaxel-coated balloons (PCB).
Purpose of the Study:
- To conduct an updated meta-analysis comparing clinical and angiographic outcomes of SCB and PCB in percutaneous coronary intervention (PCI).
- To evaluate the comparative efficacy of SCB versus PCB in coronary revascularization.
Main Methods:
- A comprehensive literature search was performed on PubMed, Scopus, and ScienceDirect.
- Included studies directly compared SCB and PCB in PCI.
- Primary endpoint was target lesion failure (TLF); secondary endpoints included minimal lumen diameter (MLD), late lumen loss (LLL), and diameter stenosis. Certainty of evidence was assessed using GRADE.
Main Results:
- Thirteen studies with 5947 patients (4097 SCB, 1850 PCB) were analyzed.
- No significant differences were observed in TLF, cardiac death, target lesion revascularization (TLR), or target vessel myocardial infarction (TVMI) between SCB and PCB.
- Angiographic outcomes were comparable, with a minor exception of smaller in-segment MLD with SCB, which lacked robustness in sensitivity analysis. Certainty of evidence was moderate for clinical and low-to-moderate for angiographic outcomes.
Conclusions:
- SCB and PCB demonstrate comparable efficacy in PCI.
- No significant differences in clinical or angiographic endpoints were found between SCB and PCB, regardless of lesion types.
- The findings suggest similar effectiveness for both types of drug-coated balloons in coronary interventions.
Abstract:
Drug-coated balloons are an emerging strategy for coronary revascularization. Despite their increasing use, the comparative efficacy of sirolimus-versus paclitaxel-coated balloons (SCB vs PCB) remains uncertain. This updated meta-analysis evaluated clinical and angiographic outcomes of SCB and PCB in percutaneous coronary intervention (PCI). A comprehensive search of PubMed, Scopus, and ScienceDirect was performed on August 28, 2025. Studies directly comparing SCB and PCB were included. The primary endpoint was target lesion failure (TLF), which was defined as cardiac death, target vessel myocardial infarction (TVMI), or target lesion revascularization (TLR). On follow-up angiography, secondary endpoints consisted of minimal lumen diameter (MLD), late lumen loss (LLL), and diameter stenosis. Pairwise meta-analyses, subgroup analyses, and sensitivity analyses were performed. The certainty of evidence was evaluated with GRADE. Thirteen studies with 5947 patients (4097 SCB and 1850 PCB) were analyzed. SCB and PCB showed no significant differences in TLF (RR 1.10, 95% CI 0.84 to 1.44), cardiac death (RR 1.19, 95% CI 0.56 to 2.53), TLR (RR 1.12, 95% CI 0.91 to 1.37), and TVMI (RR 1.82, 95% CI 0.58 to 5.72). Subgroup analyses by lesion type and study design were consistent. Angiographic outcomes were comparable between groups, except for smaller insegment MLD with SCB (MD -0.10 mm, 95% CI -0.18 to -0.02; p = 0.01), although this finding was not robust in sensitivity analysis. Certainty of evidence was moderate for clinical outcomes and low to moderate for angiographic outcomes, primarily downgraded due to imprecision and inconsistency. In conclusion, SCB and PCB demonstrated comparable efficacy in PCI, with no significant differences in clinical and angiographic endpoints, irrespective of lesion types.
