Outcomes of drug-coated balloon combined with stenting vs. stenting alone in the treatment of femoropopliteal artery lesions requiring bailout stenting.

OBJECTIVES

In the endovascular treatment of femoropopliteal peripheral arterial disease (PAD), bare metal stents (BMS) are frequently employed as a bailout option. However, in-stent restenosis (ISR) and subsequent reintervention remain a challenge. With the increasing adoption of drug-eluting devices, drug-coated balloons (DCBs) have garnered much attention as an adjunctive strategy. This study aims to evaluate whether the addition of DCBs to bailout stenting improves clinical outcomes.

METHODS

Patients who underwent endovascular procedures with bailout stenting for femoropopliteal artery (FPA) lesions from January 2019 to September 2023 were retrospectively investigated. The primary endpoints were freedom from clinically driven target lesion revascularization (CD-TLR) and survival rates. Inverse probability of treatment weighting (IPTW) was employed to balance the baseline characteristics, thereby ensuring comparability between the two groups.

RESULTS

The study cohort included 148 consecutive patients with FPA lesions requiring bailout stenting after plain old balloon angioplasty (POBA). Among them, 118 patients received POBA followed by BMS (POBA + BMS group), and 30 patients received POBA and DCB prior to BMS (POBA + DCB + BMS group). At 1-year follow-up, the POBA + DCB + BMS group demonstrated a significantly higher freedom from CD-TLR (log-rank P = 0.03) compared to the POBA + BMS group, with fewer events (2 vs. 29). However, IPTW-adjusted Cox analysis showed a non-significant trend toward reduced CD-TLR risk (HR 0.43, 95% CI 0.10–1.83; P = 0.26), whereas multivariable Cox analysis demonstrated a significant association (HR 0.20, 95% CI 0.04–0.87; P = 0.03). At 2 years, no significant difference in CD-TLR was observed between groups. No significant differences were observed in mortality or other secondary endpoints.

CONCLUSIONS

In patients requiring bailout stenting for FPA lesions, adjunctive DCB use was associated with lower 1-year CD-TLR; however, this finding should be considered hypothesis-generating due to the retrospective design and limited sample size. No sustained benefit was observed at 2 years. No signal for increased short-term mortality was identified, although the study was not powered for safety endpoints.