Key result
Drug-coated balloon treatment for de novo chronic total occlusions resulted in a 16.7% rate of major adverse cardiac events at 2 years, driven primarily by target vessel revascularization.
Why the study?
The safety and efficacy of drug-coated balloon treatment for de novo coronary chronic total occlusions remained uncertain.
Observational (n=84)
Yes
Drug-coated balloon only treatment for de novo chronic total occlusions after successful balloon angioplasty demonstrates acceptable 2-year MACE rates and low rates of hard clinical endpoints.
DCB-only treatment after successful balloon angioplasty in de novo CTO shows encouraging 2-year outcomes; leaves open confirmation via randomized trials before wider use.
Background The safety and efficacy of drug-coated balloon (DCB) treatment for de novo coronary chronic total occlusion (CTO) remain uncertain. The aim of this study was to evaluate the outcomes of DCB only treatment for de novo CTO. Methods In this retrospective study, 101 vessels with de novo CTO lesions dilated by balloon angioplasty with thrombolysis in myocardial infarction flow grade 3 were included. Among them, 93 vessels successfully treated with DCB only treatment were analyzed. The study endpoint was major adverse cardiac events (MACE) at 2 years, 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. Results All 84 patients were followed up clinically, and 67 vessels underwent scheduled coronary angiography after 6 months. There were no procedural complications, and three vessels required bailout-stenting. The median follow-up was 720 days (interquartile range [IQR]; 406–1,268 days). MACE occurred in 8.3% of the patients after 1 year, including cardiac death (1.2%), TVR (7.1%), and no non-fatal MI and target vessel thrombosis. Two years after treatment, MACE occurred in 16.7% of the patients, including cardiac death (2.4%), non-fatal MI (3.6%), TVR (13.1%), and no target vessel thrombosis. The mean LLL was 0.03 ± 0.53 mm. Binary restenosis occurred in 14.9% of the treated vessels, and 3.0% of the vessels had late re-occlusion on follow-up coronary angiography. Conclusions If the result of revascularization using balloon angioplasty is good, the clinical outcomes of DCB only treatment of de novo CTOs at the 2-year follow-up are encouraging, with a low rate of hard endpoints and acceptable MACE rates (Clinical Trial Registration Information; Impact of Drug-coated Balloon Treatment in de novo Coronary Lesion; NCT04619277).
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Jun et al. (2022) conducted an observational in de novo coronary chronic total occlusion (CTO) (n=84). Drug-coated balloon (DCB) was evaluated on Major adverse cardiac events (MACE) at 2 years. Drug-coated balloon treatment for de novo chronic total occlusions resulted in a 16.7% rate of major adverse cardiac events at 2 years, driven primarily by target vessel revascularization.
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