Clinical outcomes of drug-coated balloon angioplasty with or without Jetstream atherectomy for severely calcified femoropopliteal lesions: a Japanese real-world study

Background Severely calcified femoropopliteal (FP) lesions remain challenging. Jetstream atherectomy (JET) may improve lesion preparation before drug-coated balloon (DCB) angioplasty, but evidence in Japanese real-world practice, with a high comorbidity burden, is limited. Purpose To determine whether JET confers incremental clinical benefit over DCB alone in severely calcified FP lesions. Methods This was a single-center retrospective study of de novo or restenotic FP lesions with severe calcification (PACSS 3-4) treated with JET+DCB or DCB alone (April 2022-December 2024). The primary endpoint was 1-year primary patency assessed by Kaplan-Meier analysis. Secondary endpoints were post-procedural intravascular ultrasound (IVUS) minimum lumen area (MLA), freedom from target lesion revascularization (TLR), and freedom from major adverse limb events (MALE; major amputation or surgical reconstruction). An IVUS subgroup analysis stratified lesions by calcified nodules. Results Among 171 patients, 43.2% were on hemodialysis; mean lesion length was 156 ± 99 mm and chronic total occlusion (CTO) was present in 23.7%. Baseline hemodialysis rate, lesion length, and CTO prevalence were comparable between groups. One-year primary patency was similar with JET+DCB versus DCB alone (79.4% vs 75.0%, P=0.48). JET achieved a larger post-procedural MLA (16.0 ± 5.5 vs 13.8 ± 4.9 mm2, P=0.006). Freedom from TLR was comparable (84.1% vs 78.7%, P=0.38), as was freedom from MALE. In the calcified-nodule subgroup, JET resulted in greater acute luminal gain, but 1-year patency remained similar. Conclusion In this Japanese real-world cohort with frequent hemodialysis and long lesions, JET increased acute lumen area but did not translate into improved 1-year patency or limb-related outcomes versus DCB alone.