Objective
to investigate the three-year outcomes and evaluate the mid-term effects of drug-coated balloons with drug-eluting stents
Study
prospective, multicentre, open-label, randomised non-inferiority trial
Population
patients undergoing PCI for ACS/CCS with de novo, non-complex coronary artery disease (12 vessels, lesion length 60 mm, no left main, graft, or CTO lesions) after successful pre-dilatation, randomised 1:1 to DCB with optional rescue DES or intended DES
Endpoints
device-oriented composite (cardiovascular death, target vessel myocardial infarction, and clinically and physiologically indicated target lesion revascularisation) assessed in the intended-to-treat population
Conclusion
In patients with de novo coronary artery disease, DCB angioplasty with rescue stenting remained inferior to intended DES implantation, with higher DOCE rates, indicating that DES offers superior mid-term device-oriented outcomes for de novo non-complex CAD.
Tao et al. J Am Coll Cardiol. 2025 Oct. 27.