Comparison of Sirolimus-Versus Paclitaxel-Coated Balloons in Coronary Artery Disease: One-Year Results of Two Real-World Prospective Registries.

BACKGROUND: Paclitaxel-(PCB) and sirolimus-coated balloons (SCB) are used for treatment of in-stent restenosis (ISR) and de novo (DN) lesions. Studies comparing major adverse cardiac events (MACE) after PCB versus SCB are limited.

AIMS: This study aims to contribute to this knowledge gap and enhance the understanding of optimal strategies for treating ISR and DN lesions.

METHODS: EASTBOURNE and PEARL are large-scale, prospective clinical registries, evaluating the performance of drug-coated balloons. PEARL included patients who underwent percutaneous coronary intervention using Protege PCB and EASTBOURNE included patients treated with MagicTouch SCB in study centers in Europe and Asia. We combined these registries and used logistic regression analysis to assess the association between SCB/PCB and the likelihood of experiencing MACE, a composite of all-cause mortality, myocardial infarction (MI) and target-lesion revascularisation (TLR) at 1-year follow-up.

RESULTS: Out of 2596 patients, MACE was observed more frequently in ISR lesions (n = 1292 patients, SCB:17.8% vs. PCB:14.1%, p = 0.12) versus DN lesions (n = 1304 patients, SCB:6.4% vs. PCB:6.1%, p = 1.00). The adjusted hazards ratio (HR) for MACE was 1.17 (95% CI: 0.59-1.23, p = 0.40). As regards DN lesions, no significant difference was found in MACE (SCB: 6.4% vs. PCB 6.1%, p = 1.00). The adjusted HR for MACE was 1.24 (95% CI: 0.20-2.01, p = 0.13). There were no differences in the individual components of the primary endpoint.

CONCLUSIONS: This real-world comparison demonstrated comparable outcomes between new-generation PCB and SCB in terms of MACE at 1-year follow-up, across different lesion settings.