BACKGROUND The long-term benefit of revascularization for intermittent claudication is poorly understood. The aim of this study was to investigate the long-term effectiveness and cost-effectiveness compared with a noninvasive approach. METHODS The IRONIC trial (Invasive Revascularization or Not in Intermittent Claudication) randomized patients with mild-to-severe intermittent claudication to either revascularization + best medical therapy + structured exercise therapy (the revascularization group) or best medical therapy + structured exercise therapy (the nonrevascularization group). The health-related quality of life short form 36 questionnaire was primary outcome and disease-specific health-related quality of life (vascular quality of life questionnaire) and treadmill walking distances were secondary end points. Health-related quality of life has previously been reported superior in the revascularization group at 1- and 2-year follow-up. In this study, the 5-year results were determined. The cost-effectiveness of the treatment options was analyzed from a payer/healthcare standpoint. RESULTS Altogether, 158 patients were randomized in a 1:1 ratio. Regarding the primary end point, no intergroup differences were observed for the short form 36 sum or domain scores from baseline to 5 years, except for the short form 36 role emotional domain score, with greater improvement in the nonrevascularization group (n=116, P=0.007). No intergroup differences were observed in the vascular quality of life questionnaire total and domain scores (n=116, NS) or in treadmill walking distances (n=91, NS). A revascularization strategy resulted in almost twice the cost per patient compared with a noninvasive treatment approach ($13 098 versus $6965, P=0.02). CONCLUSIONS After 5 years of follow-up, a revascularization strategy had lost its early benefit and did not result in any long-term improvement in health-related quality of life or walking capacity compared to a noninvasive treatment strategy. Revascularization was not a cost-effective treatment option from a payer/healthcare point of view. CLINICAL TRIAL REGISTRATION URL: https://www.clinicaltrials.gov. Unique identifier: NCT01219842.

中文翻译：

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间歇性lau行患者缺乏血运重建的长期益处：IRONIC随机对照试验的五年结果。

背景技术人们很少了解血运重建对间歇性lau行的长期益处。这项研究的目的是调查与非侵入性方法相比的长期有效性和成本效益。方法IRONIC试验（有创血管重建或非间歇性lau行）将轻度至重度间歇性lau行的患者随机分为血管重建+最佳药物治疗+结构化运动疗法（血管重建术组）或最佳药物治疗+结构化运动疗法（非血管重建术）组）。与健康相关的生活质量简表36问卷是主要结局指标，与疾病相关的与健康相关的生活质量（血管生活质量问卷）和跑步机步行距离是次要终点。先前有报道称，在1年和2年的随访中，血运重建组的与健康相关的生活质量更高。在这项研究中，确定了5年的结果。从付款人/医疗保健的角度分析了治疗方案的成本效益。结果总共有158例患者以1：1的比例被随机分配。在主要终点方面，从基线到5年，简短的36形式总和或领域得分未见组间差异，除了简短的36角色情感领域得分，非血运重建组的改善更大（n = 116，P = 0.007）。在血管生活质量问卷总分和领域得分（n = 116，NS）或跑步机步行距离（n = 91，NS）中未观察到组间差异。与非侵入性治疗方法相比，血运重建策略导致每位患者的费用几乎翻了一番（13098美元对6965美元，P = 0.02）。结论经过5年的随访，与无创治疗策略相比，血运重建策略已失去其早期获益，并且并未长期改善与健康相关的生活质量或步行能力。从付款人/医疗保健的角度来看，血运重建不是一种具有成本效益的治疗选择。临床试验注册网址：https：//www.clinicaltrials.gov。唯一标识符：NCT01219842。与无创治疗策略相比，血运重建策略已失去其早期收益，并且并未导致与健康相关的生活质量或步行能力的任何长期改善。从付款人/医疗保健的角度来看，血运重建不是一种具有成本效益的治疗选择。临床试验注册网址：https：//www.clinicaltrials.gov。唯一标识符：NCT01219842。与无创治疗策略相比，血运重建策略已失去其早期收益，并且并未导致与健康相关的生活质量或步行能力的任何长期改善。从付款人/医疗保健的角度来看，血运重建不是一种具有成本效益的治疗选择。临床试验注册网址：https：//www.clinicaltrials.gov。唯一标识符：NCT01219842。