Endovascular Treatment for Calcified Femoropopliteal Peripheral Artery Disease and Risk Factor Identification: Two Year Outcomes of the Evolusion Study.

Abstract

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. 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. 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. 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.