Abstract：
BACKGROUND: Iloprost has been proposed as an alternative to amputation in Critical Limb Ischemia (CLI) patients when revascularization was unsuccessful or not possible. Nonetheless, there is limited evidence of its benefit. The main objective was to evaluate the effectiveness of iloprost and the secondary objective was to evaluate its safety.
METHODS: In this cohort study including CLI patients from the COPART registry from 2006/10 to 2021/01, patients exposed to iloprost were matched with up to three unexposed patients according to age, sex, and Propensity Score (PS) for exposure to iloprost. The main outcome combined the occurrence of all-cause death and major amputations; survival was assessed over one-year using Kaplan-Meier estimates and Cox model analyses. Major Adverse Cardiovascular Events (MACE) were chosen as the safety outcome; the association with iloprost was estimated using a logistic regression model.
RESULTS: Among 1850 CLI patients, 201 were exposed to iloprost (71.6% men; median age: 72 years vs. 72.1%; 75 years for unexposed). In 134 exposed patients matched to 375 unexposed patients, 14 major amputations and 24 deaths occurred in exposed patients (28.4%) vs. 33 and 46 respectively in the unexposed patients (20.9%). The hazard ratio (HR) was of 1.49 (95% Confidence Interval: 1.01-2.20). The association remained in the subgroup of \"no option\" patients (HR: 1.74; [1.01-2.20]). Regarding safety, 21/201 (10.7%) exposed patients experienced MACE vs. 146/1649 (9.41%) unexposed patients (unadjusted Odds Ratio [OR]: 1.17 [0.72-1.90]; adjusted OR: 1.23 [0.72-2.11]).
CONCLUSIONS: The study did not find any benefit of iloprost in CLI patients and even suggested a deleterious effect.
METHODS: In this cohort study including CLI patients from the COPART registry from 2006/10 to 2021/01, patients exposed to iloprost were matched with up to three unexposed patients according to age, sex, and Propensity Score (PS) for exposure to iloprost. The main outcome combined the occurrence of all-cause death and major amputations; survival was assessed over one-year using Kaplan-Meier estimates and Cox model analyses. Major Adverse Cardiovascular Events (MACE) were chosen as the safety outcome; the association with iloprost was estimated using a logistic regression model.
RESULTS: Among 1850 CLI patients, 201 were exposed to iloprost (71.6% men; median age: 72 years vs. 72.1%; 75 years for unexposed). In 134 exposed patients matched to 375 unexposed patients, 14 major amputations and 24 deaths occurred in exposed patients (28.4%) vs. 33 and 46 respectively in the unexposed patients (20.9%). The hazard ratio (HR) was of 1.49 (95% Confidence Interval: 1.01-2.20). The association remained in the subgroup of \"no option\" patients (HR: 1.74; [1.01-2.20]). Regarding safety, 21/201 (10.7%) exposed patients experienced MACE vs. 146/1649 (9.41%) unexposed patients (unadjusted Odds Ratio [OR]: 1.17 [0.72-1.90]; adjusted OR: 1.23 [0.72-2.11]).
CONCLUSIONS: The study did not find any benefit of iloprost in CLI patients and even suggested a deleterious effect.
摘要：
背景：在严重肢体缺血（CLI）患者中，当血运重建不成功或不可能时，已提出伊洛前列素替代截肢。尽管如此，有有限的证据表明它的好处。主要目的是评估伊洛前列素的有效性，次要目的是评估其安全性。
方法：在这项队列研究中，包括2006/10至2021/01年COPART注册的CLI患者，根据年龄将暴露于伊洛前列素的患者与三名未暴露的患者进行匹配，性别,和伊洛前列素暴露倾向评分(PS)。主要结果结合了全因死亡和严重截肢的发生；使用Kaplan-Meier估计和Cox模型分析评估了一年的生存率。选择主要不良心血管事件（MACE）作为安全性结果；使用逻辑回归模型评估与伊洛前列素的关联。
结果：在1850名CLI患者中，201人暴露于伊洛前列素(71.6%的男性；平均年龄：72岁vs.72.1%；未暴露75年）。在134名暴露患者中，与375名未暴露患者相匹配，暴露患者中发生14例主要截肢和24例死亡（28.4%）在未暴露的患者中分别为33和46（20.9％）。风险比(HR)为1.49(95%置信区间:1.01-2.20)。在“无选择”患者亚组（HR：1.74;[1.01-2.20]）中，相关性仍然存在。关于安全,21/201（10.7％）暴露患者经历MACE与146/1649（9.41%）未暴露患者（未调整赔率比[OR]：1.17[0.72-1.90]；调整后OR：1.23[0.72-2.11]）。
结论：该研究未发现伊洛前列素对CLI患者有任何益处，甚至提示有有害作用。
方法：在这项队列研究中，包括2006/10至2021/01年COPART注册的CLI患者，根据年龄将暴露于伊洛前列素的患者与三名未暴露的患者进行匹配，性别,和伊洛前列素暴露倾向评分(PS)。主要结果结合了全因死亡和严重截肢的发生；使用Kaplan-Meier估计和Cox模型分析评估了一年的生存率。选择主要不良心血管事件（MACE）作为安全性结果；使用逻辑回归模型评估与伊洛前列素的关联。
结果：在1850名CLI患者中，201人暴露于伊洛前列素(71.6%的男性；平均年龄：72岁vs.72.1%；未暴露75年）。在134名暴露患者中，与375名未暴露患者相匹配，暴露患者中发生14例主要截肢和24例死亡（28.4%）在未暴露的患者中分别为33和46（20.9％）。风险比(HR)为1.49(95%置信区间:1.01-2.20)。在“无选择”患者亚组（HR：1.74;[1.01-2.20]）中，相关性仍然存在。关于安全,21/201（10.7％）暴露患者经历MACE与146/1649（9.41%）未暴露患者（未调整赔率比[OR]：1.17[0.72-1.90]；调整后OR：1.23[0.72-2.11]）。
结论：该研究未发现伊洛前列素对CLI患者有任何益处，甚至提示有有害作用。
