Division of Cardiology, Rocky Mountain Regional VA Medical Center, University of Colorado, Denver, CO, USA.
Advanced Cardiac and Vascular Centers for Amputation Prevention, Grand Rapids, MI, USA.
J Endovasc Ther. 2021 Apr;28(2):262-274. doi: 10.1177/1526602820962972. Epub 2020 Oct 5.
To report the 3-year results of the LIBERTY 360 study, which investigated outcomes of endovascular treatment of symptomatic peripheral artery disease (PAD).
The LIBERTY trial ( identifier NCT01855412) was a prospective, observational, core laboratory-assessed, multicenter study of endovascular interventions enrolling >1200 participants treated at 51 sites. Data from 1189 patients were stratified according to Rutherford category (RC) and analyzed [RC 2-3 (n=500), RC 4-5 (n=589), and RC 6 (n=100)]. The primary outcomes were major amputation of the target limb and all-cause death; secondary outcomes were target vessel revascularization (TVR) or target lesion revascularization (TLR); major adverse events (MAEs; death within 30 days, TVR or TLR, and major amputation); death or major amputation combined; and change in self-reported quality of life (QoL) measures (VascuQol-25). The Kaplan-Meier (KM) method was employed to estimate the outcomes; estimates are presented with the 95% confidence intervals (CI). Predictors of 3-year MAE, death, TVR, and major amputation were analyzed using Cox proportional hazard regression modeling.
The 36-month KM survival rates were 86.0% in RC 2-3, 79.8% in RC 4-5, and 62.0% in RC 6 groups. The KM estimates of freedom from major amputation at 36 months were 98.5% in RC 2-3, 94.0% in RC 4-5, and 79.9% in RC 6. The 36-month KM estimates for freedom from TVR/TLR were 71.1% in RC 2-3, 64.2% in RC 4-5 and 61.9% in RC 6 groups. Patients with claudication at baseline were at lower risk for MAEs compared with RC 4-5 and RC 6 patients during the 36-month follow-up. Vascular QoL improved from baseline and persisted up to 36 months in all patients.
Endovascular therapy is a viable treatment option for patients with symptomatic PAD, with sustained improved quality of life in both claudicants and patients with chronic limb-threatening ischemia. These results provide important point estimates for midterm outcomes after modern endovascular interventions for PAD.
报告 LIBERTY 360 研究的 3 年结果，该研究调查了有症状外周动脉疾病（PAD）的血管内治疗结果。
LIBERTY 试验（标识符 NCT01855412）是一项前瞻性、观察性、核心实验室评估、多中心研究，纳入了 1200 多名在 51 个地点接受治疗的血管内介入患者。根据 Rutherford 分类（RC）对 1189 名患者的数据进行分层，并进行分析[RC 2-3（n=500）、RC 4-5（n=589）和 RC 6（n=100）]。主要结局是靶肢主要截肢和全因死亡；次要结局是靶血管血运重建（TVR）或靶病变血运重建（TLR）；主要不良事件（MAE；30 天内死亡、TVR 或 TLR 和主要截肢）；死亡或主要截肢联合；以及自我报告的生活质量（QoL）测量（VascuQol-25）的变化。采用 Kaplan-Meier（KM）法估计结局；估计值带有 95%置信区间（CI）。使用 Cox 比例风险回归模型分析了 3 年 MAE、死亡、TVR 和主要截肢的预测因素。
RC 2-3、RC 4-5 和 RC 6 组的 36 个月 KM 生存率分别为 86.0%、79.8%和 62.0%。RC 2-3 组 36 个月时免于主要截肢的 KM 估计值为 98.5%，RC 4-5 组为 94.0%，RC 6 组为 79.9%。RC 2-3 组 36 个月时免于 TVR/TLR 的 KM 估计值为 71.1%，RC 4-5 组为 64.2%，RC 6 组为 61.9%。基线时跛行的患者在 36 个月的随访中与 RC 4-5 和 RC 6 患者相比，MAE 的风险较低。所有患者的血管 QoL 均从基线开始改善，并持续至 36 个月。
血管内治疗是有症状 PAD 患者的可行治疗选择，可改善跛行和慢性肢体威胁性缺血患者的生活质量。这些结果为 PAD 现代血管内干预后的中期结果提供了重要的点估计。
