Clinical Efficacy and Safety of Paclitaxel-coated vs. Limus-coated Balloons in Coronary Interventions: A Review of the literature.

BACKGROUND: The principle of complete vessel restoration in percutaneous coronary intervention (PCI) has highlighted the significance of drug-coated balloons (DCBs) as a crucial substitute for enduring metallic stents, associated with potential hazards like neoatherosclerosis and delayed stent thrombosis. Although paclitaxel-coated balloons (PCBs) are widely accepted as the preferred option for managing in-stent restenosis (ISR) due to their lipophilic and cytotoxic characteristics, sirolimus-coated balloons (SCBs) have surfaced as a potentially less risky alternative, exploiting a cytostatic mode of action. METHODS: This review synthesizes clinical evidence from 10 randomized controlled trials (RCTs) and 7 meta-analyses published between 2020 and 2025. The analysis focuses on comparative safety and efficacy across major indications: in-stent restenosis (ISR), de novo small vessel disease (SVD), and bifurcation lesions. RESULTS: • In-Stent Restenosis (ISR): Multiple trials (e.g., Scheller et al. 2022, BIO ASCEND ISR) demonstrated the non-inferiority of limus-based platforms compared to PCBs. For instance, late lumen loss (LLL) was nearly identical between groups (0.25 mm for PCB vs. 0.26 mm for SCB). However, the REFORM trial failed to show non-inferiority for a biolimus-coated balloon, highlighting that outcomes are often device-specific rather than a class effect. • De Novo Small Vessel Disease: Outcomes in this category were more heterogeneous. In the TRANSFORM I trial, the MagicTouch SCB failed to meet non-inferiority for net lumen gain compared to the SeQuent Please Neo PCB. Conversely, other studies observed comparable LLL between the two platforms. • Safety Profile: Across most indications, Major Adverse Cardiac Events (MACE) and Target Lesion Failure (TLF) rates were comparable between paclitaxel and sirolimus platforms at 12-month follow-up. PCBs demonstrated a higher frequency of "late lumen enlargement" compared to SCBs. CONCLUSION: Both paclitaxel and sirolimus-based DCBs are effective for treating in-stent restenosis. However, in de novo lesions, PCBs currently maintain a more consistent evidence base. Clinical performance appears heavily dependent on device-specific factors such as coating technology and excipient formulation rather than a general class effect. Extended follow-up data (3-5 years) are still required to fully evaluate long-term safety and the risk of very late thrombosis.