Drug-Coated Balloon Versus Drug-Eluting Stent for Femoropopliteal Lesions: A 3-Year Propensity Score-Matched Analysis.

OBJECTIVE

While drug-eluting treatment is a first-line therapy for femoropopliteal (FP) lesions, long-term comparative data between drug-eluting stents (DES) and drug-coated balloons (DCB) in real-world practice are scarce. We aimed to compare the 3-year outcomes of DES versus DCB for symptomatic FP disease.

METHODS

We conducted a retrospective analysis of the CILANTRO study, a multicenter registry combining data from the CAPSICUM, POPCORN, and POPCORN Type R studies. Patients treated with either DES or DCB for symptomatic FP lesions were included. To minimize selection bias, we performed 1:1 propensity score matching. The primary outcome was clinically driven target lesion revascularization (TLR), while secondary outcomes included restenosis.

RESULTS

A total of 2651 patients treated with DCB and 972 with DES were identified. Propensity score matching extracted 912 pairs with well-balanced baseline characteristics. The median follow-up period was 31.6 months. The 3-year rate of TLR was not significantly different between the DCB and DES groups (23.3% vs. 18.8%; hazard ratio, 1.19 [95% confidence interval, 0.93-1.53]; p = 0.16). Interaction analysis revealed that a more marked increased risk of TLR in the DCB group in patients with semi-compliant balloon use or without non-compliant balloon use (p = 0.017 and 0.018). The 3-year rate of restenosis was significantly higher in the DCB group than in the DES group (38.1% vs. 26.3%; hazard ratio, 1.77 [1.43-2.19]; p < 0.001).

CONCLUSIONS

In this propensity score-matched analysis, the 3-year rate of TLR was not significantly different between DCB and DES, although DES demonstrated lower restenosis rate. Nevertheless, DCB remains a clinically viable option, and our sub-analysis suggests that balloon selection for pre-dilatation may influence its efficacy.