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症状性外周动脉疾病患者早期有创和无创治疗后一年的健康状况结果。

One-Year Health Status Outcomes Following Early Invasive and Noninvasive Treatment in Symptomatic Peripheral Artery Disease.

机构信息

Department of Internal Medicine, University of Missouri Kansas City School of Medicine (S.A.).

Department of Cardiology, Saint Luke's Mid America Heart Institute (V.H., J.A.S.), University of Missouri-Kansas City.

出版信息

Circ Cardiovasc Interv. 2022 Jun;15(6):e011506. doi: 10.1161/CIRCINTERVENTIONS.121.011506. Epub 2022 May 17.

Abstract

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; <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 (<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.

摘要

背景

根据患者偏好,建议将生活方式改变和药物治疗作为跛行的一线治疗方法,对于治疗抵抗症状,则考虑血运重建。缺乏比较早期侵入性与非侵入性管理策略对健康状况结局影响的真实世界证据。

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患者为中心的结局:调查轨迹)登记研究中,新出现或恶化的跛行患者在就诊时以及 3、6 和 12 个月后通过外周动脉问卷评估疾病特异性健康状况。使用分层广义线性重复测量模型,根据基线健康状况进行调整,对倾向匹配样本中早期血运重建与非侵入性管理的一年健康状况轨迹进行比较。

结果

在倾向匹配的 1000 例患者(67.4±9.3 岁,62.8%为男性,82.4%为白人)中,297 例(29.7%)进行了早期血运重建,703 例(70.3%)接受了非侵入性治疗。在 1 年的随访期间,接受早期侵入性治疗的患者报告的健康状况明显高于接受非侵入性治疗的患者(时间和治疗策略的交互项;所有外周动脉问卷领域均<0.001)。早期侵入性治疗组的外周动脉问卷综合评分平均 1 年变化为 30.8±25.2,而非侵入性治疗组为 16.7±23.4(<0.001)。

结论

在 1 年的时间内,接受早期侵入性治疗的跛行患者的健康状况改善程度大于接受非侵入性治疗的患者。这些数据可用于支持与患者的共同决策。

注册

网址:https://www.clinicaltrials.gov;唯一标识符:NCT01419080。

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