The American journal of cardiology · 2026
Chocolate Balloon Versus Conventional Balloon for Vessel Preparation Before Drug-Coated Balloon Angioplasty in Femoropopliteal Lesions: A Real-World Propensity Score-Matched Study.
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Li Chunbo, Zhu Youpeng, Yang Wenbo, Du Ye, Song Qiong, Wang Tingyu, Wang Xinyuan, Li Leixin, Chen Zhimin, Feng Zibo
Аннотация
OBJECTIVE: To evaluate the procedural and 1-year clinical outcomes of the Chocolate balloon versus conventional plain old balloon angioplasty (POBA) for vessel preparation before drug-coated balloon (DCB) treatment of femoropopliteal lesions.
METHODS: This retrospective subgroup analysis of the multicenter PROMISING registry included patients with femoropopliteal lesions treated with DCB. Before propensity score matching (PSM), 817 patients underwent POBA and 379 underwent Chocolate balloon angioplasty. After 1:1 PSM, 254 patients were included in each group. The primary endpoint was bailout stenting. Secondary endpoints included maximum DCB diameter, stent length, postprocedural ankle-brachial index (ABI), 1-year clinically driven target lesion revascularization (CD-TLR), major amputation, all-cause mortality, amputation-free survival (AFS), and major adverse events (MAE).
RESULTS: After PSM, bailout stenting occurred less frequently in the Chocolate balloon group than in the POBA group (20.47% vs 29.92%, p=0.014). The Chocolate balloon group also showed a trend toward shorter stent length (20.67±9.75 cm vs 23.71±10.62 cm, p=0.097) and allowed use of larger DCBs (4.96±0.52 mm vs 4.74±0.61 mm, p<0.001). Multivariable logistic regression identified Chocolate balloon use as an independent protective factor against bailout stenting, whereas chronic total occlusion and severe calcification were independent predictors of bailout stenting. No significant differences were observed in 1-year clinical outcomes.
CONCLUSIONS: Compared with POBA, Chocolate balloon vessel preparation reduced bailout stenting and enabled use of larger DCBs, suggesting potential procedural advantages in complex femoropopliteal lesions. However, these procedural benefits did not translate into improved 1-year clinical outcomes.
METHODS: This retrospective subgroup analysis of the multicenter PROMISING registry included patients with femoropopliteal lesions treated with DCB. Before propensity score matching (PSM), 817 patients underwent POBA and 379 underwent Chocolate balloon angioplasty. After 1:1 PSM, 254 patients were included in each group. The primary endpoint was bailout stenting. Secondary endpoints included maximum DCB diameter, stent length, postprocedural ankle-brachial index (ABI), 1-year clinically driven target lesion revascularization (CD-TLR), major amputation, all-cause mortality, amputation-free survival (AFS), and major adverse events (MAE).
RESULTS: After PSM, bailout stenting occurred less frequently in the Chocolate balloon group than in the POBA group (20.47% vs 29.92%, p=0.014). The Chocolate balloon group also showed a trend toward shorter stent length (20.67±9.75 cm vs 23.71±10.62 cm, p=0.097) and allowed use of larger DCBs (4.96±0.52 mm vs 4.74±0.61 mm, p<0.001). Multivariable logistic regression identified Chocolate balloon use as an independent protective factor against bailout stenting, whereas chronic total occlusion and severe calcification were independent predictors of bailout stenting. No significant differences were observed in 1-year clinical outcomes.
CONCLUSIONS: Compared with POBA, Chocolate balloon vessel preparation reduced bailout stenting and enabled use of larger DCBs, suggesting potential procedural advantages in complex femoropopliteal lesions. However, these procedural benefits did not translate into improved 1-year clinical outcomes.