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生物可吸收血管支架(ABSORB™)治疗的冠心病患者的生活质量:GABI-R 注册研究的 2 年结果。

Quality of life of patients with coronary heart disease treated with the bioresorbable vascular scaffold (ABSORB™): 2-year results from the GABI-R-registry.

机构信息

Institute for Health Care Management and Research, University Duisburg-Essen, Thea-Leymann-Str. 9, 45127, Essen, Germany.

University of Giessen, Medical Clinic I, 35392, Giessen, Germany.

出版信息

BMC Cardiovasc Disord. 2022 Aug 20;22(1):379. doi: 10.1186/s12872-022-02815-2.

Abstract

BACKGROUND

Numerous studies have reported clinical endpoints following coronary revascularization using bioresorbable vascular scaffolds (BVS), while information about the impact on health-related quality of life is sparse. In this analysis of the German-Austrian ABSORB RegIstRy, the 2 year results concerning quality of life development in a large cohort of patients treated with BVS were reported.

METHODS

Data were collected at baseline as well as 30 days, 6 and 24 months after coronary revascularization using BVS. The EQ-5D score, EQ visual analogue scale (VAS) and Seattle Angina Questionnaire (SAQ) were determined for each time point. Patients were categorized according to the indication for coronary revascularization [acute coronary syndrome (ACS), stable angina pectoris (SAP), silent myocardial ischemia (SMI), or other]. Binary logistic regression analysis was performed to determine factors that predict above-average scores two years after implantation.

RESULTS

Data from 1317 patients in 88 centres were included. Reasons for revascularization were: ACS (n = 643), SAP (n = 443), SMI (n = 52), and other (n = 179). Mean EQ-5D was significantly increased after six months, while a value comparable to baseline was found two years after implantation. EQ VAS and four of five dimensions of SAQ were significantly improved over baseline at all follow-up surveys. Particularly strong improvements were seen in SAQ scores angina frequency and quality of life. Binary regressions showed different statistically significant predictors in the respective models.

CONCLUSIONS

Following coronary revascularization with BVS strong decrease in self-reported angina frequency and increase of self-reported quality of life were observed with continuous improvements over two years of follow-up. Trial registration ClinicalTrials.gov Identifier: NCT02066623.

摘要

背景

大量研究报告了使用生物可吸收血管支架(BVS)进行冠状动脉血运重建后的临床终点,但关于对健康相关生活质量影响的信息却很少。在德国-奥地利 ABSORB 注册研究的这项分析中,报告了在接受 BVS 治疗的大患者队列中,2 年生活质量发展的结果。

方法

在使用 BVS 进行冠状动脉血运重建后的 30 天、6 个月和 24 个月时,分别在基线时收集数据。每个时间点都确定了 EQ-5D 评分、EQ 视觉模拟量表(VAS)和西雅图心绞痛问卷(SAQ)。根据冠状动脉血运重建的指征对患者进行分类[急性冠状动脉综合征(ACS)、稳定型心绞痛(SAP)、无症状性心肌缺血(SMI)或其他]。采用二元逻辑回归分析确定植入后两年预测高于平均水平的评分的因素。

结果

共纳入 88 个中心的 1317 例患者。血运重建的原因是:ACS(n=643)、SAP(n=443)、SMI(n=52)和其他(n=179)。六个月后,EQ-5D 均值显著升高,而植入两年后发现与基线值相当。EQ VAS 和 SAQ 的五个维度中的四个在所有随访调查中均显著优于基线。SAQ 评分的心绞痛发作频率和生活质量改善尤为明显。二元回归显示,在各自的模型中,存在不同的统计学显著预测因素。

结论

在使用 BVS 进行冠状动脉血运重建后,观察到自我报告的心绞痛发作频率明显下降,自我报告的生活质量明显提高,并且在两年的随访中持续改善。试验注册ClinicalTrials.gov 标识符:NCT02066623。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/209b/9392935/c0ea586b0e8f/12872_2022_2815_Fig1_HTML.jpg

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