Drug-Coated Balloon Intervention in Large Coronary Arteries: Immediate Procedural Results and One-Year Follow-Up

Abstract

Background

Drug-coated balloons (DCBs) are an established treatment for in-stent restenosis and small-vessel coronary disease, but evidence for large de novo coronary artery lesions remains limited.

Methods

We prospectively evaluated patients undergoing percutaneous coronary intervention (PCI) with DCB for de novo lesions in large coronary arteries (reference vessel diameter ≥ 2.75 mm). All lesions underwent adequate predilatation, and DCBs were used as the definitive treatment strategy. Bailout stenting was performed in cases of significant recoil or flow-limiting dissection. Outcomes included procedural success, in-hospital complications, and major adverse cardiovascular events (MACEs) at 12-month follow-up, defined as cardiac death, target vessel myocardial infarction, or clinically driven target lesion revascularization (TLR).

Results

A total of 539 DCB-treated lesions were evaluated, of which 451 were excluded. The final cohort comprised 88 de novo lesions in large coronary vessels from 75 patients. DCB-only treatment was performed in 65.9%; 34.1% underwent additional PCI with stenting of nonindex lesions. Post-DCB dissections occurred in 50% and were predominantly NHLBI type A. Stenting was required in three cases, including one acute vessel closure, one severe recoil with residual stenosis during the index procedure, and one early vessel closure 11 h after the index procedure requiring repeat PCI. Mean acute gain on QCA was 0.93 ± 0.45 mm. Complete 12-month follow-up was achieved in 100% of patients. MACE at 12-month follow-up occurred in 2.7% (2/75), comprising one non-ST-segment elevation myocardial infarction and one clinically driven TLR. TLR was 1.3% at 12 months. One noncardiac death occurred and was not included in the MACE endpoint. No stroke or major bleeding was observed.

Conclusions

DCB angioplasty in selected de novo large coronary lesions was feasible and associated with high procedural success and favorable 1-year outcomes. Larger studies with longer follow-ups are warranted to confirm these findings.