1. Drug-Coated Balloon Angioplasty of the Side Branch During Provisional Stenting: The Multicenter Randomized DCB-BIF Trial.
- Author
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Gao X, Tian N, Kan J, Li P, Wang M, Sheiban I, Figini F, Deng J, Chen X, Santoso T, Shin ES, Munawar M, Wen S, Wang Z, Nie S, Li Y, Xu T, Wang B, Ye F, Zhang J, Shou X, and Chen SL
- Subjects
- Humans, Female, Male, Middle Aged, Aged, Coated Materials, Biocompatible, Drug-Eluting Stents, Coronary Stenosis therapy, Coronary Stenosis surgery, Coronary Stenosis diagnostic imaging, Stents, Coronary Artery Disease therapy, Coronary Artery Disease surgery, Coronary Angiography, Treatment Outcome, Angioplasty, Balloon, Coronary methods, Angioplasty, Balloon, Coronary instrumentation
- Abstract
Background: Side branch stenting is often required during provisional stenting, leading to suboptimal results. Drug-coated balloons (DCB) for the compromised side branch have emerged as an attractive strategy. However, the benefit of DCB for coronary bifurcations remains unclear., Objectives: This study aimed to investigate whether DCB, compared with a noncompliant balloon (NCB), for the pinched side branch improves the outcomes of provisional stenting in patients with simple, true coronary bifurcations., Methods: In this multicenter, randomized controlled trial, patients with true coronary bifurcations who had side branch diameter stenosis of ≥70% after main vessel stenting at 22 centers in China, Indonesia, Italy, and Korea were randomly assigned to either DCB or NCB intervention. The primary endpoint was major adverse cardiac events, a composite of cardiac death, target vessel myocardial infarction, or clinically driven target-lesion revascularization at the 1-year follow-up., Results: Between September 8, 2020, and June 2, 2023, 784 patients with true coronary bifurcation lesions undergoing main vessel stenting and having a severely compromised side branch were randomly assigned to the DCB (n = 391) or NCB (n = 393) group. One-year follow-up was completed in all patients. The primary endpoint occurred in 28 patients in the DCB group and 49 patients in the NCB group (Kaplan-Meier rate: 7.2% vs 12.5%; HR: 0.56; 95% CI: 0.35-0.88; P = 0.013), driven by a reduction in myocardial infarction. There were no significant differences between groups in procedural success, crossover to a 2-stent approach, all-cause death, revascularization, or stent thrombosis., Conclusions: In patients with simple and true coronary bifurcation lesions undergoing provisional stenting, main vessel stenting with a DCB for the compromised side branch resulted in a lower 1-year rate of the composite outcome compared with an NCB intervention for the side branch. The high rates of periprocedural myocardial infarction, which occurred early and did not lead to revascularization, are of unclear clinical significance., Competing Interests: Funding Support and Author Disclosures This trial was funded by the National Key Research and Development Plan (2022YFC2503503), the Chinese Society of Cardiology (grant number CSCF 2019-A0003), the National Natural Scientific Foundation of China (grant numbers NSFC 91639303, 81770441, and 82121001), and the Jiangsu Provincial and Nanjing Municipal Clinical Trial Project (grant number BE 2019615) and jointly supplied by B Braun Medical (Melsungen, German), Shenqi Medical (Shanghai, China), Yinyi Medical (Dalian, China), Yingsheng Medical (Shanghai, China), and Kaidenuo Medical (Wuhan, China). The authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2025 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)
- Published
- 2025
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