The JOKER Study: Jetstream Atherectomy for DebulKing of Calcified Femoropopliteal Artery Disease: Early Outcomes From a Multicenter Retrospective Study

BACKGROUND: Endovascular therapy (EVT) for lower limb artery disease with severe calcification is challenging, as lesions may be unresponsive to balloon dilatation and may hinder full scaffold expansion. The Jetstream atherectomy device has been introduced to address these heavily calcified lower limb arterial lesions; however, its safety and effectiveness remain uncertain. This study aimed to evaluate the clinical outcomes of EVT using the Jetstream atherectomy device for severely calcified lesions. METHODS: Patients who underwent treatment with the Jetstream system between November 2022 and October 2024 across four centers were enrolled (238 patients, 307 lesions). The safety outcome was a composite outcome that included cases of non-recovered flow deterioration, intra-procedural vessel perforation/rupture, and in-hospital limb major amputation. The primary efficacy endpoint was the primary patency rate, and the secondary efficacy endpoint was clinically driven target lesion revascularization (CD-TLR) at 1 year. RESULTS: The mean patient age was 75.0 years; 31.9% were female, and 38.2% were receiving hemodialysis. The mean lesion length was 176.5 mm, and 63.2% of lesions demonstrated severe calcification (PACSS grade 4). Regarding device use, drug-coated balloons (DCB) were applied in 95.4% of cases, whereas stents were implanted in 10 cases (3.3%). The safety composite endpoint occurred in 4.2%. The primary patency rate at 1 year was 83.8%, and freedom from CD-TLR at 1 year was 91.1%. Multivariable analysis identified non-de novo lesions, occlusive lesions, smaller reference vessel diameter, and smaller maximum Jetstream device size as independent predictors of primary patency loss. In contrast, IVUS-derived parameters assessed after DCB treatment were not associated with primary patency loss. CONCLUSION: Jetstream atherectomy demonstrated a safety profile comparable to that reported in previous atherectomy studies and was associated with favorable outcomes in severely calcified femoropopliteal lesions. These findings should be considered hypothesis-generating.