Korean Circ J.  2022 Jun;52(6):444-454. 10.4070/kcj.2021.0261.

Clinical Results of Drug-Coated Balloon Treatment in a Large-Scale Multicenter Korean Registry Study

• Lee SY
• Cho YK
• Kim SW
• Hong YJ
• Koo BK
• Bae JW
• Lee SH
• Yang TH
• Park HS
• Choi SW
• Lim DS
• Kim SJ
• Jeong YH
• Lee HJ
• Lee KY
• Shin ES
• Kim U
• Kim MH
• Nam CW
• Hur SH
• Kim DI
• on behalf of the Stent Failure Research Group (SFR) Drug coated balloon (DCB) registry investigators

• KMID: 2530449
• DOI: http://doi.org/10.4070/kcj.2021.0261

Abstract

Background and Objectives
The aim of this study was to demonstrate the efficacy and safety of treatment with drug-coated balloon (DCB) in a large real-world population.
Methods
Patients treated with DCBs were included in a multicenter observational registry that enrolled patients from 18 hospitals in Korea between January 2009 and December 2017. The primary outcome was target lesion failure (TLF) defined as a composite of cardiovascular death, target vessel myocardial infarction, and clinically indicated target lesion revascularization at 12 months.
Results
The study included 2,509 patients with 2,666 DCB-treated coronary artery lesions (1,688 [63.3%] with in-stent restenosis [ISR] lesions vs. 978 [36.7%] with de novo lesions). The mean age with standard deviation was 65.7±11.3 years; 65.7% of the patients were men. At 12 months, the primary outcome, TLF, occurred in 179 (6.7%), 151 (8.9%), 28 (2.9%) patients among the total, ISR, and de novo lesion populations, respectively. A history of hypertension, diabetes, acute coronary syndrome, previous coronary artery bypass graft, reduced left ventricular ejection fraction, B2C lesion and ISR lesion were independent predictors of 12 months TLF in the overall study population.
Conclusions
This large multicenter DCB registry study revealed the favorable clinical outcome of DCB treatment in real-world practice in patient with ISR lesion as well as small de novo coronary lesion.

Keyword

Coronary stenosis; Angioplasties; coronary balloon

Figure

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  Figure 1 Survival analysis of target lesion failure.ISR = in-stent restenosis.

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  Figure 2 Survival analysis of target lesion failure according to various subgroups.Event free survival according to (A) diabetes mellitus, (B) ACS, (C) MVD, and (D) bifurcation lesion.ACS = acute coronary syndrome; ISR = in-stent restenosis; MVD = multivessel disease.

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