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

Affiliations
  • 1Division of Cardiology, Chung-Ang University Gwangmyeong Hospital and Department of Internal Medicine, ChungAng University College of Medicine, Gwangmyeong, Korea
  • 2Department of Cardiology, Keimyung University Dongsan Hospital, Daegu, Korea
  • 3Department of Internal Medicine, Chung-Ang University Hospital, Chung-Ang University College of Medicine, Seoul, Korea
  • 4Department of Internal Medicine, Chonnam National University Hospital, Chonnam National University College of Medicine, Gwangju, Korea
  • 5Department of Internal Medicine, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Korea
  • 6Department of Internal Medicine, Chungbuk National University Hospital, Chungbuk National University College of Medicine, Cheongju, Korea
  • 7Department of Internal Medicine, Wonju Severance Christian Hospital, Yonsei University, Wonju College of Medicine, Wonju, Korea
  • 8Department of Internal Medicine, Inje University Busan Paik Hospital, Inje University College of Medicine, Busan, Korea
  • 9Department of Internal Medicine, Kyungpook National University Hospital, Kyungpook National University School of Medicine, Daegu, Korea
  • 10Department of Internal Medicine, Chungnam National University Hospital, Chungnam National University College of Medicine, Daejeon, Korea
  • 11Department of Internal Medicine, Korea University Anam Hospital, Korea University College of Medicine, Seoul, Korea
  • 12Department of Internal Medicine, Kyung Hee University Medical Center, Kyung Hee University College of Medicine, Seoul, Korea
  • 13Department of Internal Medicine, Gyeongsang National University Changwon Hospital, Gyeongsang National University School of Medicine, Changwon, Korea
  • 14Bucheon Sejong Hospital, Bucheon, Korea
  • 15Incheon Saint Mary's Hospital, Incheon, Korea
  • 16Department of Internal Medicine, Ulsan University Hospital, Ulsan University College of Medicine, Ulsan, Korea
  • 17Department of Internal Medicine, Yeungnam University Medical Center, Yeungnam University College of Medicine, Daegu, Korea
  • 18Department of Internal Medicine, Dong-A University Hospital, Dong-A University College of Medicine, Busan, Korea
  • 19Department of Cardiology, Inje University Haeundae Baek Hospital, Inje University College of Medicine, Busan, Korea

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

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

  • 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.


Cited by  1 articles

Drug-Coated Balloons for Unselected Real World Patients: Are We There Yet?
Fernando Alfonso, Bernardo Cortese
Korean Circ J. 2022;52(6):455-459.    doi: 10.4070/kcj.2022.0108.


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