Abstract
Severely calcified femoropopliteal (FP) lesions in patients with symptomatic peripheral artery disease (PAD) remain challenging in endovascular therapy (EVT). Although the Jetstream™ atherectomy system is a plaque-modifying device capable of debulking calcified plaque, long-term real-world data are limited. This study aimed to evaluate the 2-year clinical outcomes of EVT using Jetstream™ atherectomy followed by drug-coated balloon (DCB) angioplasty for severely calcified FP lesions. This multicenter retrospective observational study included 147 limbs from 126 patients with symptomatic PAD who underwent EVT using Jetstream™ atherectomy followed by DCB angioplasty between September 2022 and November 2025. Lesions requiring bailout stenting or including in-stent restenosis were excluded. The primary endpoint was 2-year primary patency. Time-to-event outcomes were assessed using the Kaplan-Meier method, and predictors of restenosis were evaluated using Cox proportional hazards regression analysis. Receiver operating characteristic (ROC) curve analysis was performed to determine the optimal postprocedural minimum lumen area (MLA) cutoff. Primary patency rates were 74.2% at 1 year and 49.0% at 2 years. Multivariate analysis identified a history of prior EVT and smaller postprocedural MLA as independent predictors of 2-year restenosis. ROC analysis demonstrated that a postprocedural MLA cutoff of 12.6 mm² best predicted restenosis. In patients with severely calcified FP lesions, Jetstream™ atherectomy followed by DCB angioplasty was associated with limited 2-year primary patency in this high-risk population.