Drug-Coated Balloon-Based Versus Drug-Eluting Stent-Only Treatment for Patients With High-Bleeding Risk.

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.