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首页> 外文期刊>IJC Heart & Vasculature >Futile MITRA-FR and a positive COAPT trial: Where does the evidence leave the clinicians?
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Futile MITRA-FR and a positive COAPT trial: Where does the evidence leave the clinicians?

机译：徒劳的MITRA-FR和COAPT阳性试验：证据从何处离开临床医生？

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Secondary mitral regurgitation (MR) in dilated ventricles is a cardio- vascular disease condition that has an enormous population burden and significantly contributes to the high mortality in heart failure with reduced ejection fraction (HFrEF) patients. Moreover, cardiovascular physicians and scientists have been struggling to find a therapeutic answer for secondary MR in HFEF patients over the last few decades. Previous randomized controlled trials (RCTs) looking for an annular sur- gical solution (e.g., an undersized annuloplasty ring) to a ventricular problem (i.e., left ventricular dysfunction causing annular dilatation and secondary MR) have been largely negative [1]. Recently, the results of the COAPT trial [2] comparing a percutaneous mitral-valve repair therapy (using a MitraClip device) plus medical therapy to medical therapy alone in carefully selected HFrEF patients with more than moderate secondary MR were published. The absolute risk reduction in all-cause mortality in patients receiving the MitraClip in the COAPT trial [2] was 17% which translated to a number needed to treat (NNT) of 6 to prevent one death over two years, similar NNT was observed with the use of renin-angiotensin inhibitors in HFrEF. Not only that, the results showed similarly impressive reductions in all-cause mortal- ity across the various pre-specified subgroup analyses in the COAPT trial [2]. Success and effect size of this magnitude does not happen fre- quently, and this certainly should be considered as welcoming news to the clinicians and patients alike. But a key question to consider is that if an effect size like this is biologically plausible? Especially when our percutaneous approach of treatment using the MitraClip device is fundamentally similar to what our surgical colleagues have done with an annuloplasty ring over the last few decades.
机译：扩张性心室中的继发性二尖瓣关闭不全（MR）是一种心血管疾病，具有巨大的人口负担，并且会导致射血分数（HFrEF）降低的心衰高死亡率。此外，在过去的几十年中，心血管内科医师和科学家一直在努力寻找针对HFEF患者继发性MR的治疗方法。先前寻求环形外科手术解决方案（例如，瓣环成形术环过小）（例如，导致左室功能不全导致环形扩张和继发MR）的环形外科手术解决方案（RCT）在很大程度上是负面的[1]。最近，发表了COAPT试验[2]的结果，该试验比较了经精心选择的HFrEF伴有中等程度以上继发性MR的经皮二尖瓣修复疗法（使用MitraClip装置）加药物疗法与仅药物疗法的比较。在COAPT试验中，接受MitraClip的患者的全因死亡率绝对风险降低[2]为17％，这转化为治疗（NNT）所需的数字为6，以防止两年内死亡，与之相似的NNT与肾素-血管紧张素抑制剂在HFrEF中的应用。不仅如此，结果还显示，在COAPT试验中，各种预先指定的亚组分析中，全因死亡率的下降幅度同样惊人[2]。如此规模的成功和效应规模并不会经常发生，这当然应该被视为对临床医生和患者都欢迎的消息。但是要考虑的一个关键问题是，这样的效应大小在生物学上是否合理？尤其是当我们使用MitraClip装置的经皮治疗方法与过去几十年来我们的外科同事使用瓣环成形术进行的手术基本相似时。

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