3-Year Outcomes of the OLIVE Registry, a Prospective Multicenter Study of Patients With Critical Limb Ischemia A Prospective, Multi-Center, Three-Year Follow-Up Study on Endovascular Treatment for Infra-Inguinal Vessel in Patients With Critical Limb Ischemia
3-Year Outcomes of the OLIVE Registry, a Prospective Multicenter Study of Patients With Critical Limb Ischemia A Prospective, Multi-Center, Three-Year Follow-Up Study on Endovascular Treatment for Infra-Inguinal Vessel in Patients With Critical Limb Ischemia
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DOI：
10.1016/j.jcin.2015.07.005
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发表时间：
2015-09-01
影响因子：
11.3
通讯作者：
Nanto, Shinsuke
中科院分区：
文献类型：
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作者：
Iida, Osamu;Nakamura, Masato;Nanto, Shinsuke
背景虽然有报道称，在患有腹股沟下疾病的严重肢体缺血（CLI）的OLIVE登记患者中，血管内治疗（EVT）后12个月的临床结局良好，表示“长”之义EVT后的长期结果尚不清楚。方法这是一项前瞻性多中心登记研究，连续招募接受腹股沟下用于CLI的EVT。主要结局是3年无截肢生存率（AFS），而次要结局指标是3年无主要肢体不良事件（MALE）、无伤口生存率和伤口复发率。每个结果的预后预测因子也阐明了考克斯比例风险回归分析或log-rank test.Results的3年随访的完成率为95%。3年AFS、无MALE和无伤口生存率分别为55.2%、84.0%和49.6%。术后3年伤口复发率为43.9%。多变量分析后，年龄（风险比[HR]：1.43，p = 0.001）、体重指数
OBJECTIVES This study sought to investigate the 3-year follow-up results of OLIVE registry patients.BACKGROUND Although favorable 12-month clinical outcomes after endovascular therapy (EVT) in OLIVE registry patients with critical limb ischemia (CLI) from infrainguinal disease have been reported, long-term results after EVT remain unknown.METHODS This was a prospective multicenter registry study that consecutively enrolled patients who received infrainguinal EVT for CLI. The primary outcome was 3-year amputation-free survival (AFS), whereas secondary outcome measures were 3-year freedom from major adverse limb events (MALE), wound-free survival, and wound recurrence rate. Prognostic predictors for each outcome were also elucidated by Cox proportional hazard regression analysis or the log-rank test.RESULTS The completion rate of 3-year follow-up was 95%. Three-year AFS, freedom from MALE, and wound-free survival rates were 55.2%, 84.0%, and 49.6%, respectively. Wound recurrence out to 3 years was 43.9%. After multivariable analysis, age (hazard ratio [HR]: 1.43, p = 0.001), body mass index