Authors

• Matthew Aldo Wijayanto, Faculty of Medicine, Universitas Sebelas Maret, Surakarta, Central Java, IndonesiaFollow
• Christopher Daniel Tristan, Faculty of Medicine, Universitas Sebelas Maret, Surakarta, Central Java, Indonesia
• Erlangga Masykur Kynaya, Faculty of Medicine, Universitas Sebelas Maret, Surakarta, Central Java, Indonesia
• Annisa Aghnia Rahma, Faculty of Medicine, Universitas Sebelas Maret, Surakarta, Central Java, Indonesia
• Putri Saskia Harimurti, Faculty of Medicine, Universitas Indonesia, Depok, West Java, Indonesia
• Arwin Saleh Mangkuanom, Department of Cardiology and Vascular Medicine, Faculty of Medicine, Universitas Indonesia—National Cardiovascular Center Harapan Kita, Jakarta, Indonesia
• Amir Aziz Alkatiri, Department of Cardiology and Vascular Medicine, Faculty of Medicine, Universitas Indonesia—National Cardiovascular Center Harapan Kita, Jakarta, Indonesia
• Doni Firman, Department of Cardiology and Vascular Medicine, Faculty of Medicine, Universitas Indonesia—National Cardiovascular Center Harapan Kita, Jakarta, Indonesia
• Bambang Budi Siswanto, Department of Cardiology and Vascular Medicine, Faculty of Medicine, Universitas Indonesia—National Cardiovascular Center Harapan Kita, Jakarta, Indonesia

Efficacy of Sirolimus versus Paclitaxel-Coated Balloons for Coronary Revascularization: An Updated Meta-Analysis with GRADE Assessment

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 5,947 patients (4,097 SCB and 1,850 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 in-segment 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.

Recommended Citation

Wijayanto, Matthew Aldo; Tristan, Christopher Daniel; Kynaya, Erlangga Masykur; Rahma, Annisa Aghnia; Harimurti, Putri Saskia; Mangkuanom, Arwin Saleh; Alkatiri, Amir Aziz; Firman, Doni; and Siswanto, Bambang Budi (2026) "Efficacy of Sirolimus versus Paclitaxel-Coated Balloons for Coronary Revascularization: An Updated Meta-Analysis with GRADE Assessment," Journal of the Saudi Heart Association: Vol. 38 : Iss. 2 , Article 17.
Available at: https://doi.org/10.37616/2212-5043.1508

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