Purpose: To reveal the rate of 1-year freedom from restenosis and to determine the factors associated with the restenosis risk in femoropopliteal (FP) lesions treated with a Ranger drug-coated balloon (DCB) in real-world clinical settings.
Methods: This multicenter, prospective observational study enrolled 1131 patients and 1453 de novo or restenotic FP lesions (mean age=75±9 years; female=35.3%, mean lesion length=19.2±16.0 cm; chronic total occlusion [CTO]=33.7%; severe calcification=33.7%) that underwent successful Ranger DCB angioplatsy between March 2021 and December 2022.
Results: The primary endpoint was 1-year freedom from restenosis and its associated factors. Bail-out stenting was performed in 5.3%. During the follow-up, restenosis was detected in 249 cases. Freedom from restenosis by the Kaplan-Meier analysis was estimated to be 85.2% and 81.0% at 12 and 14 months, whereas freedom from target lesion revascularization (TLR) was 91.7% and 90.0% at 12 and 14 months. The patterns of restenosis were focal (39.2%), tandem (12.3%), diffuse (17.2%), and occlusive (31.3%). Independent risk factors of restenosis were female sex, diabetes mellitus, no runoff, history of revascularization, lesion length ≥25 cm, and CTO.
Conclusions: Our study demonstrated that 1-year freedom from restenosis after Ranger DCB for FP lesions in a real-world clinical setting was acceptable. Independent predictors of restenosis were female gender, diabetes mellitus, no runoff, history of revascularization, lesion length ≥25 cm, and CTO.
Clinical Impact: Our study demonstrated the true performance of Ranger DCB in real-world practice, with a very low rate of bail-out stenting and no use of atherectomy devices. In addition, it also elucidated morphologies associated with restenosis and the risk factors for restenosis after DCB. Freedom from re-stenosis and TLR at 1-year after Range DCB angioplasty was 84.5% and 91.5%. Two thirds of restenosis had a non-occlusive pattern, and independent predictors of restenosis were female gender, diabetes mellitus, no runoff, history of revascularization, lesion length ≥25 cm, and CTO.
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