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冠状静脉窦缩小器治疗难治性心绞痛的疗效与安全性:一项系统评价和荟萃分析。

The efficacy and safety of coronary sinus reducer in refractory angina: a systematic review and meta-analysis.

作者信息

Elshahat Ahmed, Husain Muhammad Ashraf, Elbataa Ahmed, Gadelmawla Ahmed Farid, Makhlouf Hamdy A, Ibrahim Rahma AbdElfattah, Hassanin Mohammed Sabri, Rzk Fayed Mohamed, Mohamed Ahmed Elmorsy, Helmi Ahmed, Abouelmagd Moaz, Sena Ahmed O, Bahnasy Ahmed, Singer Emad, Mohamed Ahmed Almahdy, Elnaggar Mohamed Yasser, Olama Shereen Mohamed, Saleh Mahmoud G A, Shaban Esraa A, Abdelaziz Ahmed

机构信息

Faculty of Medicine, Al-Azhar University, Cairo, Egypt.

Medical Research Group of Egypt, Negida Academy, Arlington, MA, USA.

出版信息

BMC Cardiovasc Disord. 2025 Jul 19;25(1):530. doi: 10.1186/s12872-025-04617-8.

Abstract

BACKGROUND

Refractory angina is a challenging medical disorder associated with continuous anginal symptoms that do not respond to medical treatments or revascularization interventions. Coronary sinus reducer (CSR) has been introduced as a promising treatment option for patients with refractory angina. However, the avaliable evidence regarding the exact role of CSR in managing refractory angina is still inconclusive and limited by several factors, such as small sample size studies, and short follow up periods. Therefore, we conducted this study to evaluate the effectiveness and safety of CSR for managing patients with refractory angina.

METHODS

An extensive digital search of several databases encompassing PubMed, Scopus, Web of Science, and Cochrane Library was conducted from inception until August 2024. We included all studies that assessed the clinical and functional outcomes of CSR in treating patients with refractory angina. Our primary endpoint was ≥ 1 class improvement of the Canadian Cardiovascular Society (CCS) score. Secondary outcomes were implantation success, periprocedural complications, and cardiovascular mortality. We also assessed the functional outcomes, such as the six-minute walk distance (6MWD), CCS, and Seattle Angina Questionnaire (SAQ) scores.

RESULTS

20 studies comprising 1565 patients constituted our systematic review and meta-analysis. Our pooled analysis revealed that 70% (95% CI, [65-74%], P < 0.001) of the patients showed an improvement ≥ 1 class in CCS score after CSR. Additionally, the implantation success rate was 99% (95% CI [98-100%], P < 0.001), and the periprocedural complications were severely low and estimated at 2% with 95% CI of [1-3%]. The pooled analysis showed that CSR significantly improved the functional outcomes, including 6MWD, CCS score, and all SAQ domains.

CONCLUSION

CSR appears to be a safe and effective treatment for refractory angina, providing significant improvements in symptoms and quality of life. The significant success rate of implantation and very low complication rates support its use as an alternative therapy for patients not permitted for conventional revascularization.

CLINICAL TRIAL NUMBER

Not applicable.

摘要

背景

难治性心绞痛是一种具有挑战性的医学病症,伴有持续的心绞痛症状,对药物治疗或血运重建干预无反应。冠状动脉窦减压器(CSR)已被作为难治性心绞痛患者一种有前景的治疗选择引入。然而,关于CSR在治疗难治性心绞痛中的确切作用的现有证据仍不确凿,且受到几个因素的限制,如样本量小的研究以及随访期短。因此,我们开展了这项研究以评估CSR治疗难治性心绞痛患者的有效性和安全性。

方法

从数据库创建至2024年8月,对包括PubMed、Scopus、科学引文索引和考克兰图书馆在内的多个数据库进行了广泛的数字检索。我们纳入了所有评估CSR治疗难治性心绞痛患者的临床和功能结局的研究。我们的主要终点是加拿大心血管学会(CCS)评分改善≥1级。次要结局是植入成功率、围手术期并发症和心血管死亡率。我们还评估了功能结局,如六分钟步行距离(6MWD)、CCS和西雅图心绞痛问卷(SAQ)评分。

结果

20项研究共1565例患者构成了我们的系统评价和荟萃分析。我们的汇总分析显示,70%(95%可信区间,[65 - 74%],P < 0.001)的患者在接受CSR治疗后CCS评分改善≥1级。此外,植入成功率为99%(95%可信区间[98 - 百%],P < 0.001),围手术期并发症极低,估计为2%,95%可信区间为[1 - 3%]。汇总分析表明,CSR显著改善了功能结局,包括6MWD、CCS评分和所有SAQ领域。

结论

CSR似乎是治疗难治性心绞痛的一种安全有效的方法,能显著改善症状和生活质量。较高的植入成功率和极低的并发症发生率支持将其用作不适合传统血运重建患者的替代治疗。

临床试验编号

不适用。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5e6a/12275377/85b097684ec6/12872_2025_4617_Fig1_HTML.jpg

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