Comparative study of chocolate balloon versus conventional balloon on vessel preparation for femoropopliteal artery diseases: Propensity score-matched analysis of the CIVILIAN registry

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Abstract OBJECTIVE: The objective of this study was to compare the safety and effectiveness of Chocolate and conventional balloons for vessel preparation followed by drug-coated balloon (DCB) in femoropopliteal (FP) artery disease. METHODS: This was a retrospective, multi-centered real-world study. Patients’ data of demographics, lesions, and peri-procedural characteristics were consecutively collected between August 2021 and December 2022. All patients were matched through propensity score matched (PSM) analysis. Primary endpoints included the rate of flow-limiting dissections after ultimate dilatation. Secondary endpoints were the rate of bailout stenting and freedom from clinically driven target lesion revascularization (CD-TLR) at 6-month follow-up. RESULTS: Patients were finally divided into the Chocolate percutaneous transluminal angioplasty (PTA) (n = 148) and the conventional balloon (n = 148) groups after PSM. Regarding the primary endpoint, rates of flow-limiting dissections were slightly lower in the Chocolate PTA group (19.6% vs. 20.3%, P = 0.88). Sub-analysis also showed similar trends in the two groups without sequential dilatation. The rate of flow-limiting dissections was significantly lower in the Chocolate PTA group without combining predilatation (11.7% and 13.3%, P = 0.04). Predictors of bailout stenting in the Chocolate PTA group were chronic limb ischemia, severe calcification, and TASCII C/D. The overall freedom from CD-TLR rate during follow-up was 100% and 98.0% ±1.2% in the Chocolate and conventional groups, respectively (P = 0.08). CONCLUSION: Chocolate balloon combined with DCB resulted in a comparable reduced rate of severe dissections and bailout stenting in FP disease patients compared with conventional balloon, especially when combing with non-sequential dilatation. Meanwhile, the Chocolate balloon could achieve significant better outcomes for vessel preparation without performing predilatation.