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Clinical Results of Drug-Coated Balloon Treatment in a Large-Scale Multicenter Korean Registry Study
Sang Yeub Lee1, Yun-Kyeong Cho2, Sang-Wook Kim3
1Division of Cardiology, Chung-Ang University Gwangmyeong Hospital and Department of Internal Medicine, Chung-Ang University College of Medicine, Gwangmyeong, Korea.
Insights
Drug-coated balloon (DCB) treatment shows favorable real-world outcomes for coronary artery lesions, including in-stent restenosis (ISR) and small de novo lesions. The study tracked target lesion failure (TLF) in a large patient cohort.
Area of Science:
- Cardiovascular Medicine
- Interventional Cardiology
- Medical Devices
Background:
- Drug-coated balloons (DCBs) offer a therapeutic option for coronary artery disease.
- Real-world data is crucial for evaluating treatment efficacy beyond clinical trials.
Purpose of the Study:
- To assess the real-world effectiveness and safety of DCB treatment.
- To evaluate DCB performance in a large, diverse patient population.
Main Methods:
- A multicenter observational registry included 2,509 patients from 18 Korean hospitals (2009-2017).
- The primary endpoint was target lesion failure (TLF) at 12 months, a composite of cardiovascular death, target vessel myocardial infarction, and revascularization.
- Analysis included patients with in-stent restenosis (ISR) and de novo lesions.
Main Results:
- The study analyzed 2,666 DCB-treated lesions, with 63.3% being ISR and 36.7% de novo.
- Overall 12-month TLF was 6.7% (ISR: 8.9%, de novo: 2.9%).
- Predictors of TLF included hypertension, diabetes, acute coronary syndrome, prior bypass graft, reduced ejection fraction, B2C, and ISR lesions.
Conclusions:
- DCB treatment demonstrated favorable clinical outcomes in real-world practice.
- Effective for both in-stent restenosis and small de novo coronary lesions.
- Supports the use of DCBs in routine clinical care for selected patients.
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.
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