Efficacy and Safety of Drug-Coated Balloon Versus Percutaneous Transluminal Angioplasty in Below-Knee Arterial Occlusive Disease: A Meta-Analysis and Systematic Review

Abstract

Background:

Drug-coated balloon (DCB) have gained prominence as an innovative drug delivery approach in intravascular interventions. Despite its growing clinical application, the safety and efficacy of DCB, especially in the treatment of below-the-knee arterial occlusive disease, require further investigation and validation.

Objective:

This study aimed to systematically evaluate the comparative clinical outcomes of DCB versus percutaneous transluminal angioplasty (PTA) in patients with below-the-knee arterial disease.

Methods:

This systematic review and meta-analysis included studies from PubMed, Embase, and Cochrane Library (2009–2024). Two investigators independently screened the studies, extracted the data, and assessed the quality using predefined criteria. The primary outcomes were clinically-driven target lesion revascularization (CD-TLR) and binary restenosis, and the secondary outcomes included primary patency, late lumen loss, and major amputation. Safety outcomes included all-cause mortality and major adverse events (MAEs). Data were analyzed using RevMan version 5.4.

Results:

Twelve studies (2165 patients, 2986 lesions) were included, with an overall moderate-to-low quality. DCB demonstrated superior outcomes versus PTA: trend toward reduction CD-TLR (17.2% vs 23.2%; OR 0.69, 95% CI 0.47–1.01), reduced restenosis (40% vs 67.9%; OR 0.43, 95% CI 0.13–1.36), and improved 6-month primary patency (70.1% vs 50.8%; OR 2.41, 95% CI 1.00–5.84). DCB also showed reduced late lumen loss (MD -0.45, 95% CI -0.92 to 0.01), lower major amputation (12.1% vs 23.1%; OR 0.89, 95% CI 0.49–1.60), decreased mortality (16.0% vs 19.6%; OR 0.90, 95% CI 0.71–1.13), and fewer MAEs (44.1% vs 47.9%; OR 0.67, 95% CI 0.48–0.94). Detailed statistical analyses are presented in the main text of this paper.

Conclusion:

In below-the-knee arterial disease, DCB showed a trend toward reduced repeat revascularization and improved vessel patency compared to PTA, although the reduction in CD-TLR was not statistically significant. DCB demonstrated comparable safety and limb preservation outcomes. These results indicate that DCB represents a viable therapeutic option for this challenging disease.

Clinical Impact

This meta-analysis moderates expectations regarding DCB use in BTK arterial disease. While DCB appears effective in reducing reinterventions and MAEs compared to PTA, these benefits did not clearly translate to improved amputation-free survival or mortality. For clinicians, this suggests a need for cautious patient selection rather than routine escalation. The innovation lies in highlighting the apparent dissociation between surrogate markers and hard outcomes. This warrants a balanced approach: prioritizing wound care and comorbidity control, while reserving DCB for select cases where lesion characteristics may favor drug delivery.