European journal of vascular and endovascular surgery : the official journal of the European Society for Vascular Surgery · 2025
Endovascular Treatment for Calcified Femoropopliteal Peripheral Artery Disease and Risk Factor Identification: Two Year Outcomes of the Evolusion Study.
СтатьяНаблюдательное исследованиеМногоцентровое исследованиеНазвание и аннотация: Перевод пока не подготовлен
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Wang Bing, Xu Yiting, Yu Xinyu, Sun Shilong, Guo Lianrui, Ye Meng, He Chunshui, Li Qiang, Feng Zibo, Wu Ziheng
Аннотация
OBJECTIVE: This study evaluated two year clinical outcomes of endovascular treatment for femoropopliteal artery disease with moderate to severe calcification in a Chinese cohort and identified predictors of prognosis.
METHODS: This was a prospective, observational, multicentre cohort study of patients with moderate to severe calcified femoropopliteal peripheral artery disease prospectively enrolled in the Evolusion study from December 2020 to October 2023 (ClinicalTrials.gov ID: NCT04716361). Outcomes included clinically driven target limb revascularisation (CD-TLR), major adverse limb events (MALEs), major adverse cardiovascular events (MACEs), all cause mortality (ACM), Rutherford classification, and Vascular Quality of Life (VascuQoL) scores.
RESULTS: A total of 944 patients (mean age 74.7 years; 67.7% male) were enrolled, with 51.9% diagnosed with chronic limb threatening ischaemia (CLTI) and a 2 year follow up rate of 80.9%. Cumulative CD-TLR rates at 1, 3, 6, 12, 18, and 24 months were 0.54%, 1.30%, 2.54%, 5.03%, 7.43%, and 9.27%, respectively. MALE rates were 0.97%, 1.84%, 3.08%, 6.27%, 9.39%, and 11.41%, and MACE rates were 0.76%, 1.63%, 3.23%, 4.58%, 7.51%, and 8.24%, respectively. Freedom from ACM was 98.60%, 97.39%, 95.06%, 90.09%, 84.35%, and 82.29%. Statistically significant improvements in Rutherford classification and VascuQoL scores were observed throughout follow up (p < .001). Previous target limb intervention (hazard ratio [HR] 3.81; p = .022) and severe calcification (HR 1.58; p = .029) independently predicted MALEs, whereas chronic kidney disease (HR 2.73; p < .001) and CLTI (HR 2.72; p < .001) were associated with a higher ACM. Post-operative lipid lowering therapy (HR 0.58; p = .003) was a potential independent protective factor against ACM events.
CONCLUSION: This study reported two year outcomes of endovascular treatment for moderately to severely calcified femoropopliteal artery disease in a Chinese population and identified potential independent risk and protective factors to aid risk stratification and therapeutic decision making.
METHODS: This was a prospective, observational, multicentre cohort study of patients with moderate to severe calcified femoropopliteal peripheral artery disease prospectively enrolled in the Evolusion study from December 2020 to October 2023 (ClinicalTrials.gov ID: NCT04716361). Outcomes included clinically driven target limb revascularisation (CD-TLR), major adverse limb events (MALEs), major adverse cardiovascular events (MACEs), all cause mortality (ACM), Rutherford classification, and Vascular Quality of Life (VascuQoL) scores.
RESULTS: A total of 944 patients (mean age 74.7 years; 67.7% male) were enrolled, with 51.9% diagnosed with chronic limb threatening ischaemia (CLTI) and a 2 year follow up rate of 80.9%. Cumulative CD-TLR rates at 1, 3, 6, 12, 18, and 24 months were 0.54%, 1.30%, 2.54%, 5.03%, 7.43%, and 9.27%, respectively. MALE rates were 0.97%, 1.84%, 3.08%, 6.27%, 9.39%, and 11.41%, and MACE rates were 0.76%, 1.63%, 3.23%, 4.58%, 7.51%, and 8.24%, respectively. Freedom from ACM was 98.60%, 97.39%, 95.06%, 90.09%, 84.35%, and 82.29%. Statistically significant improvements in Rutherford classification and VascuQoL scores were observed throughout follow up (p < .001). Previous target limb intervention (hazard ratio [HR] 3.81; p = .022) and severe calcification (HR 1.58; p = .029) independently predicted MALEs, whereas chronic kidney disease (HR 2.73; p < .001) and CLTI (HR 2.72; p < .001) were associated with a higher ACM. Post-operative lipid lowering therapy (HR 0.58; p = .003) was a potential independent protective factor against ACM events.
CONCLUSION: This study reported two year outcomes of endovascular treatment for moderately to severely calcified femoropopliteal artery disease in a Chinese population and identified potential independent risk and protective factors to aid risk stratification and therapeutic decision making.
Предметные рубрики MeSH
HumansMaleFemaleAgedPeripheral Arterial DiseasePopliteal ArteryFemoral ArteryEndovascular ProceduresVascular CalcificationRisk FactorsProspective StudiesTreatment OutcomeAged, 80 and overQuality of LifeMiddle AgedRisk AssessmentTime FactorsChinaLimb SalvageSeverity of Illness IndexChronic Limb-Threatening Ischemia