Observational studyBMC cardiovascular disorders2026
Impact of below-the-knee runoff in patients undergoing drug-coated balloon angioplasty for femoropopliteal disease: a propensity score-matched analysis.
Observational study in BMC cardiovascular disorders, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04826705 (A Prospective, Multicenter, Observational Study of Short and Long-term Outcome in Endovascular Treatment of Femoropopliteal Arterial Occlusive Lesion With Drug-Coated Balloon), which is not on this map. Not yet cited in PubMed.
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The trial behind it
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A Prospective, Multicenter, Observational Study of Short and Long-term Outcome in Endovascular Treatment of Femoropopliteal Arterial Occlusive Lesion With Drug-Coated Balloon (PROMISING Study)
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9 authors.
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Abstract
backgroundIn a real-world setting, the impact of below-the-knee (BTK) runoff status on outcomes following drug-coated balloon (DCB) treatment for femoropopliteal (FP) lesions remains insufficiently studied, and robust evidence is still lacking.
methodsBetween 2021 and 2024, a total of 1,574 patients undergoing drug-coated balloon (DCB) treatment for femoropopliteal arterial occlusive disease were retrospectively identified from 9 centers in China. Propensity score matching was applied to minimize baseline imbalances, resulting in 155 matched pairs for subsequent analysis. Outcome measures included 12-month amputation-free survival (AFS), freedom from clinically driven target lesion revascularization (CD-TLR), all-cause mortality, major adverse event rate, and amputation rate. Predictors of 12-month AFS were also analyzed.
resultsThe mean age was 69.82 ± 9.16 years, and 78.06% of patients were male. Hypertension (71.61%), diabetes mellitus (65.48%), and hyperlipidemia (27.10%) were the predominant comorbid conditions observed in the study population. The incidence of coronary artery disease and chronic kidney disease (CKD) was 22.58% and 17.10%, respectively. The mean lesion length was 19.12 ± 11.19 cm, with 56.77% being chronic total occlusions. Kaplan-Meier analysis revealed that the 12-month AFS was 93.67% in the group with 2-3 patent BTK arteries versus 84.93% in the group with 1 patent BTK artery, a statistically significant difference (log-rank test P = 0.028). In the overall cohort, univariable analysis indicated that renal insufficiency, chronic limb-threatening ischemia (CLTI), lesion length, concomitant BTK intervention, and preprocedural BTK runoff status were significantly associated with AFS. In the multivariable model, renal insufficiency, CLTI, and preprocedural BTK runoff status remained independent predictors of AFS.
conclusionIn this multicenter real-world study, preprocedural BTK runoff status was associated with amputation-free survival after DCB treatment for femoropopliteal lesions. Compared with patients with a single patent BTK vessel, those with two or three patent BTK runoff vessels showed a lower event risk across different clinical and anatomical subgroups. These findings suggest that preprocedural BTK runoff status may serve as an important reference for risk stratification and prognostic assessment after DCB treatment.
trial registrationClinicalTrials.gov, NCT04826705.
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