Two-year real-world outcomes of coronary drug-coated balloon therapy: a retrospective comparative study of sirolimus- and paclitaxel-coated devices.

Abstract

Background: Drug-coated balloons (DCBs) represent a "leave-nothing-behind" strategy in percutaneous coronary intervention (PCI), particularly for small vessel disease and in-stent restenosis. However, long-term comparative real-world data between paclitaxel- and sirolimus-coated balloons remain limited, and the impact of lesion characteristics on outcomes is not fully understood.

Objectives: This study aimed to evaluate the 2-year clinical outcomes of coronary DCB therapy and compare the performance of sirolimus- and paclitaxel-coated balloons in a real-world cohort.

Design: Single-center retrospective cohort study.

Methods: A total of 92 consecutive patients who underwent DCB-based PCI between January 2020 and December 2022 were retrospectively analyzed. Patients were grouped according to DCB type (sirolimus vs paclitaxel). The primary endpoints were restenosis, target lesion revascularization (TLR), and major adverse cardiac events (MACE), defined as a composite of cardiac death, myocardial infarction, and TLR. Secondary outcomes included changes in angina frequency and severity, and selected laboratory parameters. Outcomes were assessed over 24-month follow-up period.

Results: The overall 2-year restenosis rate was 13.0%, with TLR occurring in 7.6% of patients, and MACE in 9.8%. Significant improvements in angina frequency and severity were observed at 3 months (both p < 0.001). C-reactive protein (CRP) levels decreased during follow-up (p = 0.01). Patients with diabetes had numerically higher rates of restenosis (15.0% vs 11.0%) and MACE (12.5% vs 9.6%) compared with nondiabetic patients, although differences were not statistically significant. Similarly, sirolimus-coated balloons were associated with lower rates of restenosis (11.7% vs 15.6%) and TLR (6.7% vs 9.4%) compared with paclitaxel-coated balloons, without statistical significance. Larger vessel diameter was associated with an increased risk of restenosis (p = 0.004).

Conclusion: In this real-world cohort, coronary DCB therapy was associated with acceptable 2-year clinical outcomes and significant symptom improvement. Although sirolimus-coated balloons showed numerically favorable results, no definitive conclusions regarding superiority can be drawn. Larger prospective studies are needed to confirm these findings and to better define optimal patient and lesion selection.

Trial registration: Not applicable.