Abstract The study aimed to investigate the impact of angiographic and clinical outcomes of the drug-coated balloon (DCB)-only treatment for de novo coronary chronic total occlusion (CTO). One hundred one vessels with de novo CTO lesions dilated by balloon angioplasty with thrombolysis in myocardial infarction (TIMI) flow-grade 3 were assigned. Among them, we analyzed 93-vessel treated using DCB-only treatment. The primary endpoint was major adverse cardiac events (MACE), a composite of cardiac death, non-fatal myocardial infarction (MI), target vessel revascularization (TVR), and target vessel thrombosis. The secondary endpoint was late lumen loss (LLL) on follow-up coronary angiography. All 84-patient were followed up clinically, and 67-vessel underwent scheduled coronary angiography after 6-month. There were no procedural complications, and three vessels required bailout-stenting. MACE occurred in 14 patients, including 2 cardiac deaths, 3 non-fatal MIs, and 11 TVRs. There was no target vessel thrombosis. The mean LLL was 0.03 ± 0.53mm. Binary restenosis occurred in 10 and re-occlusion in 2 vessels. The results from a 2-year follow-up with DCB-only treatment are encouraging, with a low rate of hard endpoints and acceptable MACE rates. It may offer an alternative to the implantation of a drug-eluting stent if the CTO lesions have TIMI flow-grade 3 after pre-dilation.
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