Key result
DCBs yield similar 6-month QFR to DES in small coronary arteries despite lower acute gain.
Why the study?
DCBs are an emerging alternative to permanent implants in de novo small vessel disease, but physiological performance comparisons with DES using μFR changes were needed.
Does a drug-coated balloon improve physiological performance (μFR) compared to a drug-eluting stent in patients undergoing PCI for de novo small vessel coronary artery disease?
RCT (n=59)
Single-blind
Does a drug-coated balloon improve physiological performance (μFR) compared to a drug-eluting stent in patients undergoing PCI for de novo small vessel coronary artery disease?
Drug-coated balloons show comparable physiological performance to drug-eluting stents at 6 months for small vessel coronary disease, with significantly lower late lumen loss.
DCBs yield equivalent 6-month QFR to DES in small vessels despite lower acute gain; confirms physiological comparability in this RCT.
BACKGROUND: Drug-coated balloons (DCB) are emerging as an alternative to permanent implants for managing de novo coronary artery disease, particularly in small vessels (SVD). This sub-analysis of the PICCOLETO II study aimed to compare the performance of DCB and DES in terms of Murray's law-based quantitative flow ratio (μFR) changes between baseline, post-percutaneous coronary intervention (PCI), and follow-up. METHODS: Patients with a clinical indication for PCI were assigned to receive either Xience DES or Elutax SV/Emperor DCB. Coronary angiograms were blindly analyzed by an independent Core Laboratory (Consorzio Futuro in Ricerca, University of Ferrara, Italy). RESULTS: Among 232 patients, 59 were included in this analysis. Pre-PCI μFR was comparable between groups (0.65 ± 0.29 vs. 0.58 ± 0.25; p = 0.20). Post-PCI, the DCB group had a lower acute functional gain compared to DES (+0.21 vs. +0.31; p = 0.064), with lower μFR values (0.86 ± 0.36 vs. 0.89 ± 0.3; p = 0.074). At 6-month follow-up, μFR values were similar between groups (0.84 ± 0.29 vs. 0.84 ± 0.31, p = 0.93), with a comparable late functional loss (-0.02 vs. -0.05; p = 0.93). Angiographic late lumen loss was significantly lower in the DCB group (-0.03 vs. +0.29 mm; p = 0.027). CONCLUSIONS: DCB-based PCI showed a trend toward less favorable immediate post-PCI functional result but a comparable performance at follow-up, suggesting its potential in treating de novo SVD.
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Fezzi et al. (2024) conducted an RCT in De novo coronary artery disease in small vessels (n=59). Elutax SV/Emperor drug-coated balloon (DCB) vs. Xience drug-eluting stent (DES) was evaluated on Murray's law-based quantitative flow ratio (μFR) at 6-month follow-up (p=0.93). Drug-coated balloons yielded a lower acute functional gain but similar quantitative flow ratio at 6 months compared to drug-eluting stents (0.84 vs 0.84; p=0.93) in small coronary arteries.
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