Drug-Coated Balloon-Based Treatment of Left Main True Bifurcation Lesion
Ae-Young Her1, Tae Hyun Kim2, Eun-Seok Shin3
1Division of Cardiology, Department of Internal Medicine, Kangwon National University College of Medicine, Kangwon National University School of Medicine, Chuncheon, South Korea.
Insights
Drug-coated balloon (DCB) treatment is a safe and effective alternative for unprotected left main (LM) true bifurcation lesions. This study found comparable 2-year outcomes between DCB-based and drug-eluting stent (DES) treatments, supporting DCB use in select patients.
Area of Science:
- Interventional Cardiology
- Vascular Medicine
- Biomaterials in Medicine
Background:
- Limited data exists on drug-coated balloon (DCB) use for left main (LM) true bifurcation lesions.
- Unprotected LM lesions pose significant treatment challenges.
Purpose of the Study:
- To assess the safety and efficacy of DCB-based strategies in treating unprotected LM true bifurcation lesions.
- To compare DCB-based treatment outcomes with traditional drug-eluting stent (DES) approaches.
Main Methods:
- Retrospective analysis of 39 patients treated with DCB (alone or with DES) for LM true bifurcation lesions.
- Comparison with 39 propensity-matched patients treated with second-generation DES from the COBIS III registry.
- Primary endpoint: Major adverse cardiovascular events (MACE) at 2-year follow-up, including cardiac death, MI, stent thrombosis, and target lesion revascularization.
Main Results:
- Baseline characteristics were similar, though the DCB group had more in-stent restenosis (ISR) lesions.
- 59% of patients in the DCB group received DCB-only treatment; no abrupt vessel closure occurred.
- Comparable 2-year MACE rates between the DCB-based group (12.8%) and the DES-only group (17.9%) (p=0.861).
Conclusions:
- DCB-based treatment shows comparable clinical outcomes to DES-only treatment for unprotected LM true bifurcation lesions at 2 years.
- DCB-based therapy is a potentially safe and effective alternative for carefully selected patients with suitable predilation.
- Further research, like the NCT04619277 trial, is warranted to confirm these findings.
Background:
There is a paucity of data regarding drug-coated balloon (DCB) treatment in the context of left main (LM) true bifurcation lesions.
Aims:
The aim of this study was to evaluate the safety and efficacy of DCB-based treatment for unprotected LM true bifurcation lesions.
Methods:
A total of 39 patients with LM true bifurcation lesion (Medina: 1,1,1/0,1,1/1,0,1) who were successfully treated with DCB alone or in combination with drug-eluting stent (DES) were retrospectively enrolled into the DCB-based group. They were compared with 39 propensity-matched patients who were treated with second-generation DES from the COBIS III registry (n = 2648). Major adverse cardiovascular events (MACE) were defined as cardiac death, myocardial infarction, stent or target lesion thrombosis, and target lesion revascularization at the 2-year follow-up.
Results:
Baseline clinical characteristics were similar between the groups, except for the prevalence of in-stent restenosis (ISR) lesions (41.0% in DCB-based group vs. 17.9% in DES-only group, p = 0.047). In the DCB-based group, 59.0% of the patients (n = 23) underwent DCB-only treatment. There were no cases of abrupt vessel closure requiring treatment following DCB application. The MACE were comparable between both groups (12.8% in DCB-based group vs. 17.9% in DES-only group, p = 0.861) after 2 years.
Conclusions:
In patients with unprotected LM true bifurcation lesions, DCB-based treatment demonstrated comparable clinical outcomes at the 2-year follow-up when compared to DES-only treatment. DCB-based treatment could be considered a safe and effective alternative to DES for carefully selected patients who have achieved satisfactory predilation results (Impact of DCB Treatment in De Novo Coronary Lesion; NCT04619277).
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