Long‑Term Safety of Paclitaxel‑Coated Balloon for <i>De Novo</i> Non-Small Coronary Lesions

Background: The efficacy of drug-coated balloons (DCB) for treating de novo coronary stenoses in non-small lesions remains unclear.Methods: Patients treated with paclitaxel-DCB were compared with patients from two second-generation drug eluting stent (DES) registries. Only patients having DES-only or DCB-only strategies were included; those with in-stent restenosis, a device diameter<2.5mm, DES bailout post-DCB treatment, or combined use of DES and DCB were excluded. The primary endpoint was a patient-oriented composite endpoint (PoCE) defined as all-cause death, any non-fatal myocardial infarction (MI), any stroke, and any revascularization at 2-year. Differences in the risk of PoCE between cohorts were compared and adjusted by propensity score matching (PSM).Findings: The study included 6,284 patients with 5,399 treated with DES and 885 with DCB. The mean device diameters were 3.05mm and 2.88mm in the DES and DCB cohort, respectively. At 2-year follow-up, the primary endpoint occurred in 531 (9.8%) patients receiving DES and 92 (10.4%) patients treated with DCB (HRPSM:1.16, 95%CI:0.83-1.64,P=0.385). All-cause death occurred in 230 (4.3%) patients in the DES group and 11 (1.2%) patients in the DCB group (HRPSM:0.36, 95%CI:0.16-0.81), any non-fatal MI occurred in 56 (1.0%) patients in the DES group and 13 (1.5%) patients in the DCB group (HRPSM:1.04, 95%CI:0.41-2.62), and any repeat revascularization occurred in 199 (3.7%) patients in the DES arm and 69 (7.8%) patients in the DCB group (HRPSM:2.02, 95%CI:1.27-3.21).Interpretation: We did not observe DCB to be associated with a higher rate of PoCE than DES in patients with de novo coronary lesions which were ≥2.5mm in diameter.Trial Registration: Registered on clinicaltrial.gov (NCT02929030, NCT03916432, and NCT05133921)Funding: The Innovation Support Program of Shaanxi Province of China (No. 2022GHJD-03).Declaration of Interests: Dr. Serruys reported receiving personal fees from Philips/Volcano, SMT, Novartis, Xeltis, Merillife outside the submitted work. No other disclosures were reported.Ethics Approval: The study was performed in accordance with the Declaration of Helsinki and was approved by the ethics committees of participant centers of each study. All the patients signed the written informed consent prior to participation.