Drug-coated balloons angioplasty versus drug-eluting stents for coronary artery bypass graft
T Aikawa, K Yamaji, T Kuno, S Kohsaka, H Ishii, Y Matsue, K Omote, N Funayama, K Ozaki, H Kunii, T Amano, T Minamino, K KozumaAbstract
Background/Introduction
Graft failure following coronary artery bypass grafting (CABG) is a common clinical problem associated with adverse cardiovascular outcomes. Although percutaneous coronary intervention (PCI) for bypass graft lesions is frequently performed in clinical practice, the optimal device strategy remains debated. Recently, drug-coated balloon (DCB) has emerged as a potential stentless alternative.
Purpose
This study aimed to compare one-year clinical outcomes between DCB and drug-eluting stent (DES) in patients undergoing PCI for bypass graft lesions.
Methods
Data were analysed from a nationwide PCI registry in Japan between 2017 and 2020. Patients who underwent PCI with DES or DCB for bypass graft lesions were included in the analysis. The primary endpoint was major adverse cardiovascular events (MACE), which were defined as a composite of all-cause death, acute coronary syndrome (ACS), and stroke within one year after PCI. The secondary endpoints included the individual components of MACE, major bleeding, and planned repeat revascularisation. Multivariable Cox proportional hazards models were used to compare outcomes, with subgroup analyses performed according to graft type (saphenous vein graft [SVG] or arterial graft [AG]).
Results
Of the 165,266 patients who underwent PCI during the study period, 780 patients underwent PCI for bypass graft lesions. After excluding 141 PCIs performed without DES or DCB, and 29 PCIs in which both DES and DCB were used, 610 PCIs were included in the final study cohort: 426 (69.8%) with DES and 184 (30.2%) with DCB alone. At one year after PCI, the incidence of MACE did not differ significantly between the DES and DCB groups (10.3% vs. 8.6%; P=0.69; Figure 1). Additionally, no significant differences were observed when outcomes were stratified by SVG or AG PCI (P=0.72 and P=0.91, respectively; Figure 1). Similarly, there were no significant differences in all-cause death (P=0.57), cardiovascular death (P=0.71), non-fatal ACS (P=0.73), non-fatal stroke (P=0.22), non-fatal major bleeding (P=0.19), and planned repeat revascularisation (P=0.33) between the DES and DCB groups (Figure 2). After multivariable adjustment, the risk of MACE was comparable for DCB and DES (adjusted hazard ratio, 1.01; 95% confidence interval, 0.58-1.76; P=0.96).
Conclusion(s)
Stentless PCI with DCB was frequently employed and demonstrated comparable one-year clinical outcomes to DES implantation for bypass graft lesions.Fig. 1.KM curves for MACE incidenceFor image description, please refer to the figure legend and surrounding text.Fig. 2.KM curves for secondary outcomesFor image description, please refer to the figure legend and surrounding text.