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Why Did COAPT Win While MITRA-FR Failed? Defining the Appropriate Patient Population for MitraClip.为什么COAPT试验成功而MITRA-FR试验失败？确定适合接受二尖瓣夹合术的患者群体。
Interv Cardiol. 2019 Feb;14(1):45-47. doi: 10.15420/icr.2018.40.1.
2
Transcatheter Edge-to-Edge Repair in 5,000 Patients With Secondary Mitral Regurgitation: COAPT Post-Approval Study.经导管缘对缘修复术治疗 5000 例继发性二尖瓣反流患者：COAPT 上市后研究。
J Am Coll Cardiol. 2023 Sep 26;82(13):1281-1297. doi: 10.1016/j.jacc.2023.07.015.
3
Treatment of functional mitral regurgitation in chronic heart failure: can we get a 'proof of concept' from the MITRA-FR and COAPT trials?慢性心力衰竭患者功能性二尖瓣反流的治疗：我们能否从 MITRA-FR 和 COAPT 试验中获得“概念验证”？
Eur J Heart Fail. 2019 Jul;21(7):852-861. doi: 10.1002/ejhf.1491. Epub 2019 May 22.
4
One more option in heart failure: correction of mitral regurgitation with MitraClip.心力衰竭的另一种选择：使用 MitraClip 治疗二尖瓣反流。
Intern Emerg Med. 2019 Oct;14(7):1033-1040. doi: 10.1007/s11739-019-02140-1. Epub 2019 Jul 11.
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An Appraisal of the Association of Clinical Outcomes With the Severity of Regurgitant Volume Relative to End-Diastolic Volume in Patients With Secondary Mitral Regurgitation.评价继发性二尖瓣反流患者反流容积与舒张末期容积比值与临床转归的相关性。
JAMA Cardiol. 2020 Apr 1;5(4):476-481. doi: 10.1001/jamacardio.2019.5980.
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Impact of Mitral Regurgitation Severity and Left Ventricular Remodeling on Outcome After MitraClip Implantation: Results From the Mitra-FR Trial.经二尖瓣夹合术治疗后二尖瓣反流严重程度和左心室重构对预后的影响：Mitra-FR 试验结果。
JACC Cardiovasc Imaging. 2021 Apr;14(4):742-752. doi: 10.1016/j.jcmg.2020.07.021. Epub 2020 Sep 16.
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Managing Mitral Regurgitation in Heart Failure-Perspectives After COAPT.心力衰竭中二尖瓣反流的管理——COAPT 后的观点
Curr Treat Options Cardiovasc Med. 2019 Dec 10;21(12):86. doi: 10.1007/s11936-019-0799-z.
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Association of Effective Regurgitation Orifice Area to Left Ventricular End-Diastolic Volume Ratio With Transcatheter Mitral Valve Repair Outcomes: A Secondary Analysis of the COAPT Trial.有效瓣口反流面积与左心室舒张末期容积比与经导管二尖瓣修复术结局的关系：COAPT 试验的二次分析。
JAMA Cardiol. 2021 Apr 1;6(4):427-436. doi: 10.1001/jamacardio.2020.7200.
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Contemporary Management of Secondary Mitral Regurgitation.继发性二尖瓣反流的当代管理
Eur Cardiol. 2020 May 12;15:e22. doi: 10.15420/ecr.2019.08. eCollection 2020 Feb.
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MITRA-FR vs. COAPT: lessons from two trials with diametrically opposed results.MITRA-FR 与 COAPT 对比：两项结果截然相反的试验带来的经验教训。
Eur Heart J Cardiovasc Imaging. 2019 Jun 1;20(6):620-624. doi: 10.1093/ehjci/jez073.

引用本文的文献

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Diagnosis and Diagnostic Challenges of Secondary Mitral Regurgitation in the Era of Transcatheter Edge-to-Edge Repair of the Mitral Valve.二尖瓣经导管缘对缘修复时代继发性二尖瓣反流的诊断及诊断挑战
J Clin Med. 2025 Jun 26;14(13):4518. doi: 10.3390/jcm14134518.
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Secondary Mitral Regurgitation: Diagnosis and Management.继发性二尖瓣反流：诊断与管理
US Cardiol. 2024 Mar 18;18:e05. doi: 10.15420/usc.2022.34. eCollection 2024.
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Ten Future Challenges in the Field of Transcatheter Mitral Valve Edge-to-Edge Repair.经导管二尖瓣缘对缘修复领域的十大未来挑战。
J Clin Med. 2024 Mar 21;13(6):1799. doi: 10.3390/jcm13061799.
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Severe functional ischaemic mitral regurgitation: is functional a misnomer for a dysfunctional valve? A case report.重度功能性缺血性二尖瓣反流：“功能性”一词用于描述功能失调的瓣膜是否用词不当？病例报告。
Eur Heart J Case Rep. 2024 Jan 30;8(2):ytae041. doi: 10.1093/ehjcr/ytae041. eCollection 2024 Feb.
5
Secondary Mitral Regurgitation: Cardiac Remodeling, Diagnosis, and Management.继发性二尖瓣反流：心脏重塑、诊断与管理
Struct Heart. 2022 Dec 23;7(3):100129. doi: 10.1016/j.shj.2022.100129. eCollection 2023 May.
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Transcatheter mitral and tricuspid interventions-the bigger picture: valvular disease as part of heart failure.经导管二尖瓣和三尖瓣介入治疗——宏观视角：瓣膜疾病作为心力衰竭的一部分
Front Cardiovasc Med. 2023 May 15;10:1091309. doi: 10.3389/fcvm.2023.1091309. eCollection 2023.
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Thirty-day and one-year outcomes following transcatheter mitral valve edge-to-edge repair versus transapical mitral valve replacement in patients with left ventricular dysfunction.左心室功能不全患者经导管二尖瓣缘对缘修复与经心尖二尖瓣置换术后30天和1年的结果
AsiaIntervention. 2023 Mar 15;9(1):78-86. doi: 10.4244/AIJ-D-22-00049. eCollection 2023 Mar.
8
Characteristics of Contemporary Randomized Clinical Trials and Their Association With the Trial Funding Source in Invasive Cardiovascular Interventions.当代随机临床试验的特征及其与心血管介入治疗试验资金来源的关系。
JAMA Intern Med. 2020 Jul 1;180(7):993-1001. doi: 10.1001/jamainternmed.2020.1670.
9
Percutaneous mitral valve repair: the necessity to redefine secondary mitral regurgitation.经皮二尖瓣修复术：重新定义继发性二尖瓣反流的必要性。
Neth Heart J. 2020 May;28(5):272-279. doi: 10.1007/s12471-020-01412-2.
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MitraClip: How Do We Reconcile the Inconsistent Findings of MITRA-FR and COAPT?MitraClip：我们如何调和 MITRA-FR 和 COAPT 研究结果的差异？
Curr Cardiol Rep. 2019 Nov 25;21(12):150. doi: 10.1007/s11886-019-1239-0.

本文引用的文献

1
Proportionate and Disproportionate Functional Mitral Regurgitation: A New Conceptual Framework That Reconciles the Results of the MITRA-FR and COAPT Trials.比例性和非比例性功能性二尖瓣反流：一个新的概念框架，调和了 MITRA-FR 和 COAPT 试验的结果。
JACC Cardiovasc Imaging. 2019 Feb;12(2):353-362. doi: 10.1016/j.jcmg.2018.11.006. Epub 2018 Dec 12.
2
Transcatheter Mitral-Valve Repair in Patients with Heart Failure.经导管二尖瓣修复术治疗心力衰竭患者。
N Engl J Med. 2018 Dec 13;379(24):2307-2318. doi: 10.1056/NEJMoa1806640. Epub 2018 Sep 23.
3
Percutaneous Repair or Medical Treatment for Secondary Mitral Regurgitation.经皮修复或药物治疗继发性二尖瓣反流。
N Engl J Med. 2018 Dec 13;379(24):2297-2306. doi: 10.1056/NEJMoa1805374. Epub 2018 Aug 27.
4
Refining the prognostic impact of functional mitral regurgitation in chronic heart failure.细化慢性心力衰竭患者功能性二尖瓣反流的预后影响。
Eur Heart J. 2018 Jan 1;39(1):39-46. doi: 10.1093/eurheartj/ehx402.
5
Survival and Cardiovascular Outcomes of Patients With Secondary Mitral Regurgitation: A Systematic Review and Meta-analysis.继发性二尖瓣反流患者的生存和心血管结局：系统评价和荟萃分析。
JAMA Cardiol. 2017 Oct 1;2(10):1130-1139. doi: 10.1001/jamacardio.2017.2976.
6
Clinical Trial Design Principles and Endpoint Definitions for Transcatheter Mitral Valve Repair and Replacement: Part 1: Clinical Trial Design Principles: A Consensus Document From the Mitral Valve Academic Research Consortium.经导管二尖瓣修复和置换的临床试验设计原则和终点定义：第 1 部分：临床试验设计原则：二尖瓣学术研究联合会的共识文件。
J Am Coll Cardiol. 2015 Jul 21;66(3):278-307. doi: 10.1016/j.jacc.2015.05.046.
7
Independent prognostic value of functional mitral regurgitation in patients with heart failure. A quantitative analysis of 1256 patients with ischaemic and non-ischaemic dilated cardiomyopathy.功能性二尖瓣反流对心力衰竭患者的独立预后价值。1256 例缺血性和非缺血性扩张型心肌病患者的定量分析。
Heart. 2011 Oct;97(20):1675-80. doi: 10.1136/hrt.2011.225789. Epub 2011 Jul 31.
8
Percutaneous repair or surgery for mitral regurgitation.经皮修复或手术治疗二尖瓣反流。
N Engl J Med. 2011 Apr 14;364(15):1395-406. doi: 10.1056/NEJMoa1009355. Epub 2011 Apr 4.
9
Ischemic mitral regurgitation: long-term outcome and prognostic implications with quantitative Doppler assessment.缺血性二尖瓣反流：定量多普勒评估的长期结果及预后意义
Circulation. 2001 Apr 3;103(13):1759-64. doi: 10.1161/01.cir.103.13.1759.

为什么COAPT试验成功而MITRA-FR试验失败？确定适合接受二尖瓣夹合术的患者群体。

Why Did COAPT Win While MITRA-FR Failed? Defining the Appropriate Patient Population for MitraClip.

作者信息

Atianzar Kimberly, Zhang Ming, Newhart Zachary, Gafoor Sameer

机构信息

Medical College of Georgia at Augusta University Augusta, GA, US.

Swedish Heart and Vascular Institute Seattle, WA, US.

出版信息

Interv Cardiol. 2019 Feb;14(1):45-47. doi: 10.15420/icr.2018.40.1.

DOI:10.15420/icr.2018.40.1
PMID:30858892
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC6406127/
Abstract

In 2018, the world of functional mitral regurgitation changed with the presentation of two trials - Multicentre Study of Percutaneous Mitral Valve Repair MitraClip Device in Patients With Severe Secondary Mitral Regurgitation (MITRA-FR) and Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients with Functional Mitral Regurgitation (COAPT). The trials, which seemed to point in two different directions, raised significant questions for the field. This article looks at the differences in effective regurgitant area, guideline-directed medical therapy, patient selection, technical clues and other reasons why the trials had similar aims but very different findings.

摘要

2018年，功能性二尖瓣反流领域发生了变化，两项试验——重度继发性二尖瓣反流患者经皮二尖瓣修复术MitraClip装置多中心研究（MITRA-FR）和心力衰竭合并功能性二尖瓣反流患者MitraClip经皮治疗的心血管结局评估（COAPT）公布了结果。这两项试验似乎指向两个不同的方向，给该领域带来了重大问题。本文探讨了有效反流面积、指南指导的药物治疗、患者选择、技术要点以及为何这两项试验目标相似但结果却大相径庭的其他原因。