目的:下肢急性肢体缺血(LE-ALI)发病率和死亡率高,以及患者生活质量(QoL)的负担。LE-ALI患者机械抽吸血栓切除术(MT)的中长期证据有限。STRIDE研究旨在评估LE-ALI患者使用Indigo抽吸系统进行MT的安全性和有效性。30天主要和次要终点,和以前发表的其他结果。这里,我们报告来自STRIDE的365天次要终点和QoL数据。
方法:STRIDE是一个多中心,prospective,单臂,观察性队列研究,纳入了美国和欧洲16个地点的119名患者。使用靛蓝抽吸系统(半影,Inc.Alameda,CA).该研究于2023年10月完成随访。365天的次要终点包括目标保肢,和死亡率。此外,VascuQoL-6问卷,为评估以患者为中心的外周动脉疾病QoL结局而开发的数据在基线和365天随访时进行了评估.
结果:73%(87/119)的患者可以进行365天的随访。这些患者的平均年龄为65.0±13.3岁,女性占44.8%。基线缺血严重程度被归类为卢瑟福I的12.6%,卢瑟福IIa占51.7%,卢瑟福IIb占35.6%。总的来说,基线和疾病特征(人口统计学,病史,合并症,这些患者的目标血栓)与119例患者的入组队列相似。目标保肢365天的次要终点为88.5%(77/87),死亡率为12.0%(12/100)。VascuQoL-6在所有领域都得到了改进,中位总分从基线时的12.0[IQR9.0,15.0]改善至365天的19.0[16.0,22.0].
结论:这些来自STRIDE的365天结果表明,使用Indigo抽吸系统治疗LE-ALI的一线MT表现出持续的高目标保肢率和改善的患者报告的QoL。这些发现表明靛蓝是LE-ALI安全有效的治疗选择。
OBJECTIVE: Lower extremity acute limb ischemia (LE-ALI) is associated with high morbidity and mortality rates, and a burden on patient quality of life (QoL). There is limited medium- to long-term evidence on mechanical aspiration thrombectomy (MT) in patients with LE-ALI. The STRIDE study was designed to assess safety and efficacy of MT using the Indigo Aspiration System in patients with LE-ALI. Thirty-day primary and secondary endpoints and additional outcomes were previously published. Here, we report 365-day secondary endpoints and QoL data from STRIDE.
METHODS: STRIDE was a multicenter, prospective, single-arm, observational cohort study that enrolled 119 patients across 16 sites in the United States and Europe. Patients were treated first-line with MT using the Indigo Aspiration System (Penumbra, Inc). The study completed follow-up in October 2023. Secondary endpoints at 365 days included target limb salvage and mortality. Additionally, the VascuQoL-6 questionnaire, developed for evaluating patient-centered QoL outcomes for peripheral arterial disease, was assessed at baseline and follow-up through 365 days.
RESULTS: Seventy-three percent of patients (87/119) were available for 365-day follow-up. Mean age of these patients was 65.0 ± 13.3 years, and 44.8% were female. Baseline ischemic severity was classified as Rutherford I in 12.6%, Rutherford IIa in 51.7%, and Rutherford IIb in 35.6%. In general, baseline and disease characteristics (demographics, medical history, comorbidities, target thrombus) of these patients are similar to the enrolled cohort of 119 patients. The secondary endpoints at 365 days for target limb salvage was 88.5% (77/87) and mortality rate was 12.0% (12/100). VascuQoL-6 improved across all domains, with a median total score improvement from 12.0 (interquartile range, 9.0-15.0) at baseline to 19.0 (interquartile range, 16.0-22.0) at 365 days.
CONCLUSIONS: These 365-day results from STRIDE demonstrate that first-line MT with the Indigo Aspiration System for LE-ALI portray continued high target limb salvage rates and improved patient-reported QoL. These findings indicate Indigo as a safe and effective therapeutic option for LE-ALI.