Abstract Background/Introduction: Coronary lesions are abnormalities in the coronary arteries caused primarily by atherosclerosis. They can present as de novo lesions, where the arterial lumen is narrowed for the first time, or as in-stent restenosis (ISR), which refers to re-narrowing of a previously stented arterial segment. These lesions compromise blood flow to the myocardium, leading to ischemia, angina, acute coronary syndrome, or myocardial infarction (MI). Sirolimus-coated balloons (SCBs) and paclitaxel-coated balloons (PCBs) are drug-coated balloons (DCBs) used in percutaneous coronary interventions to prevent restenosis without leaving a permanent implant. Purpose: This systematic review and meta-analysis aimed to assess whether SCBs offer comparable or superior efficacy and safety to PCBs in the treatment of coronary artery lesions. Methods: We searched PubMed, Scopus, Web of Science, and the Cochrane CENTRAL for studies comparing SCBs and PCBs in patients with coronary artery lesions, including de novo lesions, ISR lesions, or both were eligible. Screening and data extraction were performed independently by two reviewers. The meta-analysis was conducted using R (version 4.4.2; R Core Team, 2024) with a random-effects model to calculate pooled risk ratios (RRs) and corresponding 95% confidence intervals (CIs). Results: Ten studies involving 3,935 patients (SCBs: n = 2,764; PCBs: n = 1,171) were included. SCBs and PCBs demonstrated comparable results across all major endpoints. Safety outcomes showed no significant differences in all-cause mortality (RR 1.39, 95% CI 0.50–3.89, p = 0.53), cardiac death (RR 1.21, 95% CI 0.50–2.92, p = 0.67), or MI (RR 0.98, 95% CI 0.59–1.64, p = 0.95). Efficacy outcomes were similarly equivalent for target lesion failure (TLF) (RR 1.13, 95% CI 0.85–1.50, p = 0.39), target lesion revascularization (TLR) (RR 1.23, 95% CI 0.98–1.55, p = 0.068), major adverse cardiac events (MACE) (RR 1.14, 95% CI 0.91–1.43, p = 0.27), and binary restenosis (BR) (RR 1.18, 95% CI 0.63–2.20, p = 0.61). Procedural success, defined as achieving Thrombolysis in Myocardial Infarction (TIMI) III flow, was nearly universal in both groups (RR 1.00, 95% CI 0.99–1.01, p = 0.85). Subgroup analyses by lesion type (de novo, ISR, or studies including both) revealed consistent results without significant interaction effects, supporting the robustness of equivalence across clinical settings. Conclusion: None of the interventions (SCBs or PCBs) demonstrated superiority in terms of efficacy or safety for the treatment of coronary artery lesions, including both ISR and de novo lesions. Although pharmacologic differences exist between the two technologies, these did not result in significant differences in clinical outcomes in pooled analyses. Device selection should therefore be guided by lesion characteristics and overall clinical context.Forest Plot of MIFor image description, please refer to the figure legend and surrounding text. Forest Plot of TLRFor image description, please refer to the figure legend and surrounding text.
Moftah et al. (Sun,) studied this question.