Drug-coated balloon combined with stent versus stent alone for femoropopliteal disease: a systematic review and meta-analysis.

OBJECTIVES

This systematic review and meta-analysis aimed to compare the midterm efficacy and safety of drug-coated balloon-assisted stenting (DCB+stent) versus plain old balloon angioplasty-assisted stenting (POBA+stent) in patients with symptomatic femoropopliteal artery disease.

METHODS

PubMed, Embase, and the Cochrane Central Register of Controlled Trials were searched through June 2025 for randomized controlled trials (RCTs) and cohort studies comparing DCB+stent with POBA+stent. The primary endpoints were freedom from clinically driven target lesion revascularization (CD-TLR) and primary patency at midterm follow-up. All-cause mortality was assessed as a secondary endpoint. Two reviewers independently screened studies, extracted data, and assessed risk of bias. Pooled risk ratios (RRs) with 95% confidence intervals(CIs) were calculated using random-effects models to account for expected clinical heterogeneity. The certainty of evidence was appraised using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) framework. The Mantel–Haenszel method was used to compare outcomes between the two groups.

RESULTS

Eight studies (three RCTs and five cohorts) involving 1,726 patients (DCB + stent: n = 821; POBA + stent: n = 905) were included. Pooled analysis showed no statistically significant differences between groups for freedom from CD-TLR (RR = 0.95; 95% CI: 0.89–1.01; I²=34%), 12-month primary patency (RR = 0.87; 95% CI: 0.57–1.33; I²=89%), or all-cause mortality (RR = 1.35; 95% CI: 0.79–2.33; I²=0%). Sensitivity analysis excluding one trial that exclusively enrolling patients with long-segment disease (≥ 15 cm) revealed a borderline significant improvement in 1-year freedom from CD-TLR with DCB+stent (RR = 0.95; 95% CI: 0.91-1.00; I²=0%).

CONCLUSIONS

Current evidence does not support routine use of DCB as an adjunct to stenting for unselected femoropopliteal lesions, as midterm outcomes appear equivalent between the two strategies. The exploratory sensitivity analysis suggests that lesion length may influence treatment effect, warranting further lesion-length–stratified randomized trials. TRIAL REGISTRATION: PROSPERO (ID: CRD420251070990).