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Drug-Coated Balloon-Based Versus Drug-Eluting Stent-Only Treatment for Patients With High-Bleeding Risk
Eun-Seok Shin1, Sunwon Kim2, Dong Oh Kang3
1Department of Cardiology, Ulsan University Hospital, University of Ulsan College of Medicine, Ulsan, Republic of Korea.
Insights
Drug-coated balloon (DCB)-based percutaneous coronary intervention (PCI) significantly reduced cardiac mortality and major bleeding in high-bleeding risk patients. DCB-PCI offers a safer alternative to drug-eluting stent-only PCI for this challenging patient group.
Area of Science:
- Cardiology
- Interventional Cardiology
- Vascular Medicine
Background:
- Managing high-bleeding risk (HBR) patients undergoing percutaneous coronary intervention (PCI) presents significant clinical challenges.
- Limited data exists on optimal treatment strategies for HBR patients requiring PCI.
Purpose of the Study:
- To compare the clinical outcomes of drug-coated balloon (DCB)-based PCI versus drug-eluting stent (DES)-only PCI in HBR patients.
- To evaluate the safety and efficacy of DCB-based PCI in this high-risk population.
Main Methods:
- A comparative study involving 652 HBR patients treated with DCB-based PCI and 652 propensity-matched patients treated with second-generation DES-only PCI.
- Two-year follow-up was conducted to assess major adverse cardiovascular events (MACE), including cardiac mortality, target vessel revascularization, and major bleeding.
Main Results:
- DCB-based PCI demonstrated significantly lower 2-year cardiac mortality (2.0% vs. 5.2%) and target vessel revascularization rates (2.5% vs. 6.0%) compared to DES-only PCI.
- Major bleeding events were substantially reduced in the DCB-based PCI group (1.4% vs. 5.4%).
- Myocardial infarction rates were comparable between the two treatment strategies.
Conclusions:
- DCB-based PCI is associated with a significantly lower risk of MACE in HBR patients compared to DES-only treatment.
- These findings suggest DCB-based PCI is a viable and potentially superior treatment strategy for improving outcomes in HBR patients undergoing PCI.
Background:
Managing patients with high-bleeding risk (HBR) requiring percutaneous coronary intervention (PCI) is challenging, and data are limited.
Aims:
This study investigates the clinical outcomes of drug-coated balloon (DCB)-based PCI compared to drug-eluting stent (DES)-only PCI in patients with HBR undergoing PCI.
Methods:
We included 652 consecutive patients with HBR undergoing DCB-based PCI and compared them to 652 propensity-matched patients who received conventional PCI with second-generation DES. Patients were followed up for 2 years to assess major adverse cardiovascular events (MACE).
Results:
Baseline clinical characteristics were comparable between the groups. In the DCB-based PCI group, 71.6% of patients were successfully treated with DCB alone. In the DCB-based PCI, patients had lower cardiac mortality at 2 years (2.0% vs. 5.2%; hazard ratio: 0.37; 95% confidence interval: 0.18-0.74; p = 0.005). Rates of target vessel revascularization (2.5% vs. 6.0%; hazard ratio: 0.43; 95% confidence interval: 0.24-0.78; p = 0.005), and major bleeding events (1.4% vs. 5.4%; hazard ratio: 0.26; 95% confidence interval: 0.12-0.58; p = 0.001) were also lower with DCB-based PCI than with DES-only PCI. Myocardial infarction events were comparable between the two groups. In a multivariable model, DCB-based PCI was independently associated with reduced risk of 2-year cardiac death, target vessel revascularization, and major bleeding.
Conclusion:
In patients with HBR, DCB-based PCI was associated with a significantly lower risk of MACE compared to DES-only treatment. These findings suggest that DCB-based PCI may be a viable treatment strategy for improving outcomes in patients with HBR.
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