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.
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。
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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.
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