Background:Lifestyle changes and medications are recommended as the first line of treatment for claudication, with revascularization considered for treatment-resistant symptoms, based on patients’ preferences. Real-world evidence comparing health status outcomes of early invasive with noninvasive management strategies is lacking.Methods:In the international multicenter prospective observational PORTRAIT (Patient-Centered Outcomes Related to Treatment Practices in Peripheral Arterial Disease: Investigating Trajectories) registry, disease-specific health status was assessed by the Peripheral Artery Questionnaire in patients with new-onset or worsening claudication at presentation and 3, 6, and 12 months later. One-year health status trajectories were compared by early revascularization versus noninvasive management on a propensity-matched sample using hierarchical generalized linear models for repeated measures adjusted for baseline health status.Results:In a propensity-matched sample of 1000 patients (67.4±9.3 years, 62.8% male, and 82.4% White), 297 (29.7%) underwent early revascularization and 703 (70.3%) were managed noninvasively. Over 1 year of follow-up, patients who underwent early invasive management reported significantly higher health status than patients managed noninvasively (interaction term for time and treatment strategy; P<0.001 for all Peripheral Artery Questionnaire domains). The average 1-year change in Peripheral Artery Questionnaire summary scores was 30.8±25.2 in those undergoing early invasive, compared with 16.7±23.4 in those treated noninvasively (P<0.001).Conclusions:Patients with claudication undergoing early invasive treatment had greater health status improvements over the course of 1 year than those treated noninvasively. These data can be used to support shared decision-making with patients.Registration:URL: https://www.clinicaltrials.gov; Unique identifier: NCT01419080.

中文翻译：

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有症状的外周动脉疾病早期侵入性和无创治疗后的一年健康状况结果


背景：建议改变生活方式和药物治疗作为跛行的一线治疗方法，根据患者的喜好考虑血运重建治疗难治性症状。缺乏比较早期侵入性与非侵入性管理策略的健康状况结果的真实世界证据。方法：在国际多中心前瞻性观察性 PORTRAIT（与外周动脉疾病治疗实践相关的以患者为中心的结果：调查轨迹）登记中，疾病特定的健康状况通过外周动脉问卷对就诊时以及 3、6 和 12 个月后新发或恶化跛行的患者进行状态评估。通过早期血运重建与无创管理对倾向匹配样本进行一年健康状态轨迹的比较，使用分层广义线性模型进行重复测量，并根据基线健康状况进行调整。 结果：在 1000 名患者的倾向匹配样本中（67.4±9.3 岁） ，62.8% 为男性，82.4% 为白人），297 例（29.7%）接受了早期血运重建，703 例（70.3%）接受了无创治疗。经过 1 年的随访，接受早期侵入性治疗的患者报告的健康状况显着高于接受非侵入性治疗的患者（时间和治疗策略的交互项； P <0 id=1>P <0.001）。 结论：接受早期侵入性治疗的跛行患者早期侵入性治疗在一年内比非侵入性治疗对健康状况的改善更大。这些数据可用于支持与患者共同决策。注册：URL：https://www.clinicaltrials.gov；唯一标识符：NCT01419080。