Comparing the Clinical Performance of Paclitaxel-Coated Balloons and Paclitaxel-Eluting Stent for Treating Long Femoropopliteal Artery Disease: Results of the CAPELLA Study.

BACKGROUND: Previous studies reported comparable outcomes between paclitaxel-coated balloons (PCBs) and paclitaxel-eluting stents (PESs) for femoropopliteal artery disease. However, data comparing the clinical performance of these paclitaxel devices for longer lesions in real-world clinical settings remains limited.

METHODS: In this multicenter, retrospective study, the clinical performance of the PCBs (IN.PACT and Ranger) without bailout stenting and PESs (Eluvia) were assessed in cases of femoropopliteal artery disease with lesion length ≥ 150 mm. From the database, 376 lesions in 376 individuals were assigned to the PCB group, and 268 lesions in 268 individuals were assigned to the PES group. Propensity score-matching analysis was performed to adjust for baseline individual and lesion characteristics. The primary outcome was 2-year primary patency (PP), mainly determined using duplex ultrasound, and the secondary outcomes were clinically driven target lesion revascularization, acute limb ischemia, major amputation, and mortality.

RESULTS: Propensity score matching identified 134 pairs with no significant intergroup differences in baseline individual and lesion characteristics. Average lesion length was 252.0 and 253.2 mm in the PCB and PES groups, respectively. Within 2 years, the PES group demonstrated significantly higher PP than the PCB group (80.1% vs. 68.4%, p = 0.037). In contrast, the secondary outcomes did not significantly differ between the groups. No baseline characteristics showed a significant interaction effect on the association of PCBs vs PES with loss of PP.

CONCLUSION: PP was significantly higher in the PES group than the PCB group in real-world populations with longer, complex lesions, whereas other outcomes did not significantly differ between the two groups.