Safety and efficacy of drug-eluting balloons in large coronary vessels: a lesion-level analysis of real-world PCI practice
L Hamann, D Faria, J Guerreiro Pereira, S Andraz, J Massa Pereira, A Babiciu, F Almeida Saraiva, H Costa, P De Azevedo, J Bispo, J Moura Guedes, J Mimoso, H VinhasAbstract
Background
Drug-coated balloons (DCB) are established therapy for coronary in-stent restenosis and are increasingly used in small-vessel disease, where they showed non-inferiority to DES in randomized trials such as BASKET-SMALL 2. Current ESC and international consensus documents primarily frame DCB as a strategy for ISR and de novo small vessels (<2.75–3.0 mm), with much less evidence in larger reference diameters. Concerns persist that using large-diameter DCBs may lead to suboptimal drug transfer and higher bailout DES rates. We therefore evaluated the safety of DCB ≥3.0 mm in routine practice.
Methods
We conducted a retrospective single-centre analysis of 398 consecutive patients (mean age 67.1±12.6 years, 83.2% male) treated with DEB, yielding 518 DEB-treated lesions. Lesions were stratified by mean DCB diameter: <3.0 mm (n=358) vs ≥3.0 mm (n=160). The primary endpoint was bailout DES during the index procedure (Rescue DES). Secondary endpoints were lesion-level TLF, TLR, non-TLR revascularization and all-cause death. Univariate comparisons were followed by penalized multivariable logistic regression including vessel territory, de novo vs ISR, bifurcation, lesion preparation (NC, cutting, scoring, IVL balloons), intravascular imaging and procedural complications (dissection, perforation, rupture, no-reflow).
Results
Rescue DES occurred in 35 lesions (6.8% overall): 22/358 (6.1%) with DCB <3.0 mm vs 13/160 (8.1%) with DCB ≥3.0 mm (crude OR 1.35; p=0.45). Rates of TLF, TLR, non-TLR and mortality were low in both groups (e.g. TLF 2.5% vs 3.1%; all-cause death 3.1% vs 3.8%; all p>0.7). In the multivariable ridge model, use of DCB ≥3.0 mm was not independently associated with Rescue DES (adjusted OR 0.92; 95% CI 0.15–5.58; p=0.93), whereas procedural complications remained the main driver of bailout.
Conclusions
In this real-world lesion-level cohort, larger-diameter DCBs (≥3.0 mm) were not associated with higher bailout DES rates or worse lesion-level outcomes compared with DCBs <3.0 mm. Although DCB therapy is traditionally considered a small-vessel strategy, our data suggest that, with meticulous lesion preparation and careful case selection, extending DCB use to larger epicardial vessels appears procedurally and clinically safe. These findings complement existing RCT and consensus data and support further prospective evaluation of DCB-only strategies beyond classic small-vessel indicationsBaseline CharacteristicsFor image description, please refer to the figure legend and surrounding text.OutcomesFor image description, please refer to the figure legend and surrounding text.