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Drug-Coated Balloons Versus Non-Coated Balloons for Side Branch Treatment in Bifurcation Lesions: A Systematic Review
Matteo Rocchetti1,2, Lorenzo Tua1, Alberto Cereda1
1Division of Cardiology, Cardio-Thoracic Department, San Carlo Borromeo Hospital (ASST Santi Paolo e Carlo), Milan, Italy.
Insights
Drug-coated balloons (DCBs) significantly reduce major adverse cardiac events (MACE) and myocardial infarction (MI) when treating side branches (SB) during percutaneous coronary interventions (PCI) for coronary bifurcation lesions (CBL). This offers a potential benefit over non-compliant balloons (NCBs).
Area of Science:
- Interventional Cardiology
- Vascular Medicine
- Biomedical Engineering
Background:
- Coronary bifurcation lesions (CBL) represent a significant challenge in percutaneous coronary interventions (PCI), accounting for approximately 20% of cases.
- Optimal management of the side branch (SB) in provisional stenting for CBL remains a subject of debate.
- Limited data exist on the efficacy of drug-coated balloons (DCBs) for SB treatment in CBL PCI.
Purpose of the Study:
- To conduct a meta-analysis comparing the effectiveness of drug-coated balloons (DCBs) versus non-compliant balloons (NCBs) for treating the side branch (SB) in coronary bifurcation lesion (CBL) percutaneous coronary interventions (PCI).
Main Methods:
- A systematic literature search was performed across MEDLINE, CENTRAL, and EmBase databases up to November 2024.
- Five studies, including two randomized controlled trials (RCTs) and three observational studies, involving 1762 patients (predominantly male with acute coronary syndrome) were included.
- The primary outcome was major adverse cardiac events (MACE), with secondary outcomes including myocardial infarction (MI), target lesion revascularization (TLR), and target vessel revascularization (TVR).
Main Results:
- Drug-coated balloons (DCBs) demonstrated a significant reduction in major adverse cardiac events (MACE) (pooled OR 0.48, 95% CI 0.34-0.68, p < 0.0001) compared to non-compliant balloons (NCBs).
- DCBs also significantly reduced myocardial infarction (MI) rates (pooled OR 0.39, 95% CI 0.25-0.62, p < 0.001) versus NCBs.
- No significant differences were observed between DCBs and NCBs for target lesion revascularization (TLR) or target vessel revascularization (TVR). Subgroup analyses confirmed consistency across study types.
Conclusions:
- Drug-coated balloons (DCBs) are associated with reduced MACE and MI in side branch (SB) treatment during coronary bifurcation lesion (CBL) PCI compared to non-compliant balloons (NCBs).
- The findings suggest a potential clinical benefit of DCBs in mitigating ischemic events while potentially limiting the extent of stenting in CBL.
- Further research is warranted to optimize patient selection and treatment strategies for DCB use in CBL PCI.
Background:
Coronary bifurcation lesions (CBL) account for ~20% of percutaneous coronary interventions (PCI). When using provisional stenting, optimal management of a diseased side branch (SB) remains debated. Drug-coated balloons (DCBs) are an emerging option, but data on their role in CBL PCI are limited.
Aims:
We conducted a meta-analysis to compare DCBs and non-compliant balloons (NCBs) for SB treatment.
Methods:
A systematic search of MEDLINE, CENTRAL, and EmBase (until November 2024) identified studies comparing DCBs and NCBs for treating the SB. From 1451 studies, five were included (two randomized controlled trials [RCTs], three observational), with 1762 patients, predominantly male with acute coronary syndrome (ACS). The primary outcome was major adverse cardiac events (MACE); secondary outcomes included myocardial infarction (MI), target lesion revascularization (TLR), and target vessel revascularization (TVR).
Results:
DCBs significantly reduced MACE (pooled OR 0.48, 95% CI 0.34-0.68, p < 0.0001, I² = 0%) and MI (pooled OR 0.39, 95% CI 0.25-0.62, p < 0.001, I² = 0%) compared to NCBs. No significant differences were observed in TLR or TVR. Subgroup analysis confirmed consistency across observational studies and RCTs for MACE and MI.
Conclusions:
DCBs in SB treatment during CBL PCI are associated with reduced MACE and MI compared to NCBs, with no significant differences in vessel-specific outcomes. These findings suggest a potential clinical benefit of DCBs in reducing ischemic events, while limiting stenting in CBL. Further research is needed to refine patient selection and optimize outcomes.
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