Journal of vascular surgery · 2026
Three-year outcomes of Supera interwoven nitinol stents versus Eluvia drug-eluting stents in severely calcified femoropopliteal lesions.
СтатьяМногоцентровое исследованиеСравнительное исследованиеНазвание и аннотация: Перевод в очереди
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Yanagiuchi Takashi, Tokuda Takahiro, Yoshioka Naoki, Kojima Shunsuke, Tanaka Akiko, Takei Tatsuro, Ogata Kenji, Yamaguchi Kohei, Nakama Tatsuya, Yokoi Hirokazu, LEADers PAD investigators
Аннотация
OBJECTIVE: To compare the 3-year outcomes of Supera interwoven nitinol stents (IWNS) and Eluvia fluoropolymer-based drug-eluting stents (DES) in patients with severely calcified femoropopliteal (FP) lesions.
METHODS: This multicenter retrospective study evaluated 3-year outcomes in the same cohort from eight cardiovascular centers in Japan. A total of 257 consecutive patients underwent endovascular therapy using IWNS (n = 123) or DES (n = 134) for FP lesions with severe calcification, defined as Peripheral Arterial Calcium Scoring System grade 3 or 4, between April 2018 and December 2021. Propensity score (PS) matching yielded 69 well-balanced pairs. The primary outcome was 3-year freedom from target lesion revascularization (TLR). Secondary outcomes included primary patency, overall survival, and limb salvage. Interaction analysis was performed to evaluate heterogeneity of treatment effect on TLR risk.
RESULTS: The mean follow-up period was 34.3 ± 23.6 months. In the PS-matched cohort, the 3-year freedom from TLR did not differ significantly between the IWNS and DES groups (80.2% vs 78.2%; P = .868). The 3-year primary patency rates were also comparable (69.6% vs 78.8%; P = .558). No significant between-group differences were observed in overall survival (72.8% vs 55.2%; P = .110) or limb salvage (96.0% vs 93.0%; P = .792). Interaction analysis showed significant interactions for age and lesion length, with DES associated with a greater increase in TLR risk in patients aged <75 years and in lesions ≥200 mm (Pfor interaction = .049 and .045, respectively). Restenotic lesions occurring within 1 year showed a numerically higher prevalence of occlusive restenosis or stent thrombosis after DES than after IWNS (50% vs 13%; P = .059), whereas no difference in restenosis morphology was observed beyond 1 year (P = 1.000).
CONCLUSIONS: In patients with severely calcified FP lesions, Supera IWNS and Eluvia DES demonstrated comparable 3-year outcomes after PS matching. However, the comparative effect of stent type may differ according to age and lesion length.
METHODS: This multicenter retrospective study evaluated 3-year outcomes in the same cohort from eight cardiovascular centers in Japan. A total of 257 consecutive patients underwent endovascular therapy using IWNS (n = 123) or DES (n = 134) for FP lesions with severe calcification, defined as Peripheral Arterial Calcium Scoring System grade 3 or 4, between April 2018 and December 2021. Propensity score (PS) matching yielded 69 well-balanced pairs. The primary outcome was 3-year freedom from target lesion revascularization (TLR). Secondary outcomes included primary patency, overall survival, and limb salvage. Interaction analysis was performed to evaluate heterogeneity of treatment effect on TLR risk.
RESULTS: The mean follow-up period was 34.3 ± 23.6 months. In the PS-matched cohort, the 3-year freedom from TLR did not differ significantly between the IWNS and DES groups (80.2% vs 78.2%; P = .868). The 3-year primary patency rates were also comparable (69.6% vs 78.8%; P = .558). No significant between-group differences were observed in overall survival (72.8% vs 55.2%; P = .110) or limb salvage (96.0% vs 93.0%; P = .792). Interaction analysis showed significant interactions for age and lesion length, with DES associated with a greater increase in TLR risk in patients aged <75 years and in lesions ≥200 mm (Pfor interaction = .049 and .045, respectively). Restenotic lesions occurring within 1 year showed a numerically higher prevalence of occlusive restenosis or stent thrombosis after DES than after IWNS (50% vs 13%; P = .059), whereas no difference in restenosis morphology was observed beyond 1 year (P = 1.000).
CONCLUSIONS: In patients with severely calcified FP lesions, Supera IWNS and Eluvia DES demonstrated comparable 3-year outcomes after PS matching. However, the comparative effect of stent type may differ according to age and lesion length.
Предметные рубрики MeSH
HumansAlloysPopliteal ArteryDrug-Eluting StentsRetrospective StudiesFemoral ArteryPeripheral Arterial DiseaseFemaleTime FactorsProsthesis DesignAgedVascular PatencyTreatment OutcomeJapanEndovascular ProceduresMaleLimb SalvageRisk FactorsVascular CalcificationSeverity of Illness IndexAged, 80 and overRisk AssessmentMiddle Aged