Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions · 2026
One-Year Outcomes of Drug-Coated Balloon Angioplasty With and Without the Blades-Up Function of the JETSTREAM Atherectomy Device in Femoropopliteal Calcified Lesions.
СтатьяМногоцентровое исследованиеСравнительное исследованиеНаблюдательное исследованиеНазвание и аннотация: Перевод пока не подготовлен
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Takei Tatsuro, Tokuda Takahiro, Yoshioka Naoki, Ogata Kenji, Tanaka Akiko, Kojima Shunsuke, Yamaguchi Kohei, Yanagiuchi Takashi, Nakama Tatsuya, LEADers PAD Investigators
Аннотация
BACKGROUND: The JETSTREAM atherectomy device, particularly in its blades-up mode, enables extensive debulking of calcified femoropopliteal (FP) lesions but may increase the risk of distal embolization, and its effect on patency after drug-coated balloon (DCB) angioplasty remains unclear.
AIMS: The present study aimed to evaluate the efficacy and safety of the blades-up function in JETSTREAM-assisted DCB treatment for calcified FP lesions.
METHODS: Between October 2021 and December 2024, 240 patients underwent JETSTREAM atherectomy for calcified FP lesions at eight centers in Japan. Of these, 232 who underwent DCB angioplasty alone were analyzed. Patients were stratified according to blades-up use (with or without; n = 116 each). Propensity score matching was performed to minimize baseline differences. The primary endpoint was 1-year freedom from restenosis. Secondary endpoints included 1-year freedom from clinically driven target lesion revascularization (CD-TLR), acute limb ischemia (ALI), and major amputation. Procedure-related endpoints were the minimum lumen area (MLA) at the debulked segment after DCB and the incidence of persistently impaired flow on final angiography.
RESULTS: Propensity score matching yielded 56 well-balanced pairs with no significant baseline differences. One-year freedom from restenosis was similar between the non-blades-up and blades-up groups. CD-TLR, ALI, and major amputation rates were also comparable. Among patients with available intravascular imaging data (non-blades-up group, n = 45; blades-up group, n = 42), post-DCB MLA did not differ significantly. Persistent impaired flow on final angiography was infrequent and comparable between groups.
CONCLUSIONS: Blades-up atherectomy did not provide additional benefits in vessel patency, clinical outcomes, or procedural results after DCB angioplasty. Routine blade-up use may not be necessary when treating calcified FP lesions.
TRIAL REGISTRATION: This study was not a prospective clinical trial; therefore, it was not registered.
AIMS: The present study aimed to evaluate the efficacy and safety of the blades-up function in JETSTREAM-assisted DCB treatment for calcified FP lesions.
METHODS: Between October 2021 and December 2024, 240 patients underwent JETSTREAM atherectomy for calcified FP lesions at eight centers in Japan. Of these, 232 who underwent DCB angioplasty alone were analyzed. Patients were stratified according to blades-up use (with or without; n = 116 each). Propensity score matching was performed to minimize baseline differences. The primary endpoint was 1-year freedom from restenosis. Secondary endpoints included 1-year freedom from clinically driven target lesion revascularization (CD-TLR), acute limb ischemia (ALI), and major amputation. Procedure-related endpoints were the minimum lumen area (MLA) at the debulked segment after DCB and the incidence of persistently impaired flow on final angiography.
RESULTS: Propensity score matching yielded 56 well-balanced pairs with no significant baseline differences. One-year freedom from restenosis was similar between the non-blades-up and blades-up groups. CD-TLR, ALI, and major amputation rates were also comparable. Among patients with available intravascular imaging data (non-blades-up group, n = 45; blades-up group, n = 42), post-DCB MLA did not differ significantly. Persistent impaired flow on final angiography was infrequent and comparable between groups.
CONCLUSIONS: Blades-up atherectomy did not provide additional benefits in vessel patency, clinical outcomes, or procedural results after DCB angioplasty. Routine blade-up use may not be necessary when treating calcified FP lesions.
TRIAL REGISTRATION: This study was not a prospective clinical trial; therefore, it was not registered.
Предметные рубрики MeSH
HumansPopliteal ArteryFemoral ArteryAngioplasty, BalloonPeripheral Arterial DiseaseTreatment OutcomeCoated Materials, BiocompatibleFemaleTime FactorsMaleAgedVascular PatencyAtherectomyJapanVascular CalcificationAged, 80 and overVascular Access DevicesEquipment DesignRetrospective StudiesCardiovascular AgentsRisk FactorsRecurrence