JACC. Cardiovascular interventions · 2025
3-Year Results Following Femoropopliteal Lesion Treatment With a Novel Sirolimus-Eluting Balloon.
Клиническое исследованиеСтатьяМногоцентровое исследованиеПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод в очереди
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Soga Yoshimitsu, Iida Osamu, Saito Shigeru, Mano Toshiaki, Hayakawa Naoki, Ichihashi Shigeo, Kawasaki Daizo, Suzuki Kenji, Yamaoka Terutoshi, Fujihara Masahiko, Nakama Tatsuya, Nakamura Masato, Horie Kazunori, Kozuki Amane
Аннотация
BACKGROUND: Sirolimus drug-eluting balloons (DEB) are an emerging technology for the treatment of femoropopliteal (FP) lesions, but data beyond 1 year are limited.
OBJECTIVES: The authors sought to evaluate the longer-term safety and efficacy of the SELUTION SLR DEB for treatment of FP disease in a Japanese population. The trial was registered with the Japan Registry of Clinical Trials (Clinical Study of MDK-1901 for Patients with Superficial Femoral and Popliteal Artery Lesions [SELUTION SFA JAPAN]; jRCT1080225338).
METHODS: The SELUTION SFA JAPAN study is a multicenter, prospective, single-arm study. It was independently adjudicated by an imaging core laboratory and clinical events committee. Endpoints through 36 months included primary patency, target lesion revascularization, and major adverse events.
RESULTS: A total of 134 patients were enrolled; the median follow-up was 1,089 days (Q1-Q3: 1,071-1,102 days). The mean age was 73.8 ± 6.9 years, and 60.3% of patients had diabetes mellitus. The median lesion length was 129.6 (Q1-Q3: 77.9-184.9) mm; 17.2% (23/134) were chronic total occlusions and 26.9%(36/134) were moderately to severely calcified; 1.5% (2/134) were stented during the index procedure. The 36-month primary patency rate was 81.5% (95% CI: 73.7%-87.2%) and the freedom from clinically driven target lesion revascularization (TLR) was 93.8% (95% CI: 88.0%-96.9%). The major adverse event rate was 14.2%, composed of 8 clinically driven TLRs and 11 all-cause deaths; none were related to the device or procedure. Improvements in ankle-brachial index and Rutherford class were marked and sustained through 36 months.
CONCLUSIONS: Three-year results from the SELUTION SFA JAPAN study demonstrated durability of the SELUTION DEB and confirmed it is a safe and effective treatment option for FP disease in symptomatic patients.
OBJECTIVES: The authors sought to evaluate the longer-term safety and efficacy of the SELUTION SLR DEB for treatment of FP disease in a Japanese population. The trial was registered with the Japan Registry of Clinical Trials (Clinical Study of MDK-1901 for Patients with Superficial Femoral and Popliteal Artery Lesions [SELUTION SFA JAPAN]; jRCT1080225338).
METHODS: The SELUTION SFA JAPAN study is a multicenter, prospective, single-arm study. It was independently adjudicated by an imaging core laboratory and clinical events committee. Endpoints through 36 months included primary patency, target lesion revascularization, and major adverse events.
RESULTS: A total of 134 patients were enrolled; the median follow-up was 1,089 days (Q1-Q3: 1,071-1,102 days). The mean age was 73.8 ± 6.9 years, and 60.3% of patients had diabetes mellitus. The median lesion length was 129.6 (Q1-Q3: 77.9-184.9) mm; 17.2% (23/134) were chronic total occlusions and 26.9%(36/134) were moderately to severely calcified; 1.5% (2/134) were stented during the index procedure. The 36-month primary patency rate was 81.5% (95% CI: 73.7%-87.2%) and the freedom from clinically driven target lesion revascularization (TLR) was 93.8% (95% CI: 88.0%-96.9%). The major adverse event rate was 14.2%, composed of 8 clinically driven TLRs and 11 all-cause deaths; none were related to the device or procedure. Improvements in ankle-brachial index and Rutherford class were marked and sustained through 36 months.
CONCLUSIONS: Three-year results from the SELUTION SFA JAPAN study demonstrated durability of the SELUTION DEB and confirmed it is a safe and effective treatment option for FP disease in symptomatic patients.
Предметные рубрики MeSH
AgedAged, 80 and overFemaleHumansMaleMiddle AgedAngioplasty, BalloonCardiovascular AgentsCoated Materials, BiocompatibleFemoral ArteryJapanPeripheral Arterial DiseasePopliteal ArteryProspective StudiesRegistriesRisk FactorsSirolimusTime FactorsTreatment OutcomeVascular Access DevicesVascular Patency