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在两项欧洲随机临床试验中接受新一代药物洗脱冠状动脉支架治疗的少数民族。

Ethnic minorities treated with new-generation drug-eluting coronary stents in two European randomised clinical trials.

作者信息

Ploumen Eline H, Semedo Edimir, Doggen Carine J M, Schotborgh Carl E, Anthonio Rutger L, Danse Peter W, Benit Edouard, Aminian Adel, Stoel Martin G, Hartmann Marc, van Houwelingen K Gert, Scholte Martijn, Roguin Ariel, Linssen Gerard C M, Zocca Paolo, von Birgelen Clemens

机构信息

Department of Cardiology, Thoraxcentrum Twente, Medisch Spectrum Twente, Enschede, The Netherlands.

Health Technology and Services Research, Faculty of Behavioural, Management and Social Sciences, Technical Medical Centre, University of Twente, Enschede, The Netherlands.

出版信息

Neth Heart J. 2024 Jun;32(6):254-261. doi: 10.1007/s12471-024-01873-9. Epub 2024 May 22.

Abstract

BACKGROUND

Several ethnic minorities have an increased risk of cardiovascular events, but previous European trials that investigated clinical outcome after coronary stenting did not assess the patients' ethnic background.

AIMS

To compare ethnic minority and Western European trial participants in terms of both cardiovascular risk profile and 1‑year clinical outcome after percutaneous coronary intervention.

METHODS

In the BIO-RESORT and BIONYX randomised trials, which assessed new-generation drug-eluting stents, information on patients' self-reported ethnic background was prospectively collected. Pooled patient-level data of 5803 patients, enrolled in the Netherlands and Belgium, were analysed in this prespecified analysis. The main endpoint was target vessel failure after 1 year.

RESULTS

Patients were classified as belonging to an ethnic minority (n = 293, 5%) or of Western European origin (n = 5510, 95%). Follow-up data were available in 5772 of 5803 (99.5%) patients. Ethnic minority patients were younger, less often female, more often current smokers, more often medically treated for diabetes, and more often had a positive family history of coronary artery disease. The main endpoint target vessel failure did not differ between ethnic minority and Western European patients (3.5% vs 4.9%, hazard ratio 0.71, 95% confidence interval 0.38-1.33; p = 0.28). There was also no difference in mortality, myocardial infarction, and repeat revascularisation rates.

CONCLUSIONS

Despite the unfavourable cardiovascular risk profile of ethnic minority patients, short-term clinical outcome after treatment with contemporary drug-eluting stents was highly similar to that in Western European patients. Further efforts should be made to ensure the enrolment of more ethnic minority patients in future coronary stent trials.

摘要

背景

几个少数族裔发生心血管事件的风险增加,但以往调查冠状动脉支架置入术后临床结局的欧洲试验未评估患者的种族背景。

目的

比较少数族裔和西欧试验参与者的心血管风险特征以及经皮冠状动脉介入治疗后的1年临床结局。

方法

在评估新一代药物洗脱支架的BIO-RESORT和BIONYX随机试验中,前瞻性收集了患者自我报告的种族背景信息。在这项预先设定的分析中,对荷兰和比利时纳入的5803例患者的汇总患者水平数据进行了分析。主要终点是1年后的靶血管失败。

结果

患者被分类为少数族裔(n = 293,5%)或西欧裔(n = 5510,95%)。5803例患者中有5772例(99.5%)有随访数据。少数族裔患者更年轻,女性较少,当前吸烟者较多,接受药物治疗糖尿病的频率较高,有冠状动脉疾病家族史的比例也较高。少数族裔患者和西欧患者的主要终点靶血管失败情况无差异(3.5%对4.9%,风险比0.71,95%置信区间0.38 - 1.33;p = 0.28)。死亡率、心肌梗死和再次血管重建率也无差异。

结论

尽管少数族裔患者的心血管风险特征不利,但当代药物洗脱支架治疗后的短期临床结局与西欧患者高度相似。应进一步努力确保未来冠状动脉支架试验纳入更多少数族裔患者。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/814b/11143136/420cc7e49e2f/12471_2024_1873_Fig1_HTML.jpg

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