Abbott today announced that the U.S. Food and Drug Administration (FDA) has approved a change to its label that will help patients who receive a HeartMate 3™ left ventricular assist device (LVAD, or heart pump) experience superior clinical outcomes by eliminating aspirin as part of routine patient management.

雅培今天宣布，美国食品和药物管理局（FDA）已批准对其标签进行更改，以帮助接受HeartMate 3™左心室辅助装置（LVAD或心脏泵）的患者在常规患者管理中消除阿司匹林，从而获得优异的临床效果。

The labeling update is exclusively for patients with an Abbott HeartMate 3 heart pump and has also been approved by regulatory agencies in Canada and the European Union..

标签更新仅适用于使用雅培HeartMate 3心脏泵的患者，并且已获得加拿大和欧盟监管机构的批准。。

Blood thinners have historically been used by patients receiving LVADs as a means to reduce the risk of blood clots associated with the use of a blood pump implant. The ARIES-HM3 study was designed to help clinicians understand whether aspirin is needed as part of a blood thinning regimen for HeartMate 3 patients.

历史上，接受LVAD的患者一直使用血液稀释剂来降低与使用血泵植入物相关的血栓风险。ARIES-HM3研究旨在帮助临床医生了解HeartMate 3患者是否需要阿司匹林作为血液稀释方案的一部分。

The ARIES-HM3 trial showed that patients who received an Abbott HeartMate 3 heart pump but didn't take aspirin as part of their blood-thinning medication regimen had nearly 40% fewer complications from bleeding without increasing the risk of forming a blood clot compared to patients who also received a HeartMate 3 but did take aspirin.

ARIES-HM3试验表明，接受雅培HeartMate 3心脏泵但未将阿司匹林作为血液稀释药物治疗方案的一部分的患者，与同样接受HeartMate 3但确实服用阿司匹林的患者相比，出血并发症减少了近40%，但不会增加形成血凝块的风险。

As a result of reduced bleeding risk, the ARIES-HM3 trial also found patients avoiding aspirin post-implant experienced reduced days in the hospital compared to patients who took aspirin daily..

由于出血风险降低，ARIES-HM3试验还发现，与每天服用阿司匹林的患者相比，避免服用阿司匹林的患者住院天数减少。。

'Aspirin, along with warfarin, has traditionally been mandated for advanced heart failure patients living with an LVAD, but whether it contributes to excessive bleeding has been uncertain. The ARIES-HM3 trial, in which aspirin was removed from the medication regimen, provided important data challenging the assumption that patients with a heart pump must take aspirin daily,' said Mandeep R.

阿司匹林和华法林传统上被强制用于患有LVAD的晚期心力衰竭患者，但它是否会导致过度出血尚不确定。Mandeep R说，ARIES-HM3试验将阿司匹林从药物治疗方案中删除，提供了重要数据，挑战了心脏泵患者必须每天服用阿司匹林的假设。

Mehra, M.D., executive director of the Center for Advanced Heart Disease and the William Harvey Distinguished Chair at Brigham and Women’s Hospital in Boston, MA and the principal investigator of the ARIES-HM3 trial. 'With this labeling change, physicians can avoid using aspirin in patients receiving the HeartMate 3 LVAD, a decision that is safe, and decreases bleeding and its associated hospital visits.'.

医学博士梅赫拉（Mehra）是马萨诸塞州波士顿布莱根妇女医院（Brigham and Women's Hospital）晚期心脏病中心（Center for Advanced Heart Disease）执行主任兼威廉·哈维（William Harvey）杰出主席，也是ARIES-HM3试验的首席研究员。”通过这种标签的改变，医生可以避免在接受HeartMate 3 LVAD的患者中使用阿司匹林，这是一个安全的决定，可以减少出血及其相关的医院就诊。”。

Abbott's HeartMate 3 heart pump is an implantable device that pumps blood through the body in people whose heart is too weak to do so on its own. It is the only commercially approved heart pump with Full MagLev™ technology, which allows the device's rotor to be 'suspended' by magnetic forces, a unique design that has been proven to reduce trauma to blood passing through the pump, improving patient survival and quality of life.

雅培的HeartMate 3心脏泵是一种植入式设备，可以将血液泵入心脏无力的人的体内。。

These factors have led to HeartMate 3 offering the lowest rate of pump-related complications of any other blood pump..

这些因素导致HeartMate 3的泵相关并发症发生率最低。。

Advanced Heart Failure Patients Benefit From Going Aspirin-Free

晚期心力衰竭患者不服用阿司匹林将获益匪浅

Approximately 6.7 million Americans have heart failure, and that number is expected to rise to 8.5 million by 2030.1 Heart failure is a progressive condition that occurs when the heart can't circulate blood efficiently, resulting in symptoms such as fatigue, breathlessness and swollen ankles. If not managed and treated, it can lead to poor quality of life, hospitalizations and death..

大约有 670 万美国人患有心力衰竭，预计到 2030 年，这一数字将上升到 850 万。1 心力衰竭是一种渐进性疾病，当心脏无法有效循环血液时，就会出现疲劳、呼吸困难和脚踝肿胀等症状。如果不加以控制和治疗，会导致生活质量下降、住院和死亡。

'Removing aspirin from the medication regimen for the HeartMate 3 is a simple change that means people with an Abbott LVAD can focus on the things they love and spend less time worrying about and tending to bleeding events,' said Keith Boettiger, vice president, Abbott's heart failure business. 'Through research such as the ARIES-HM3 trial, we continue to rewrite the book on the management of patients with advanced heart failure and focus on bringing lifeenhancing benefits to people who rely on our devices to survive.'.

雅培心力衰竭业务副总裁基思·博蒂格（KeithBoettiger）说，将阿司匹林从HeartMate 3的药物治疗方案中删除是一个简单的改变，这意味着雅培LVAD患者可以专注于他们喜欢的事情，减少担心和处理出血事件的时间通过ARIES-HM3试验等研究，我们继续改写关于晚期心力衰竭患者管理的书，并专注于为依赖我们设备生存的人带来增强生命的益处。”

About the ARIES-HM3 Trial

关于ARIES-HM3试验

The ARIES-HM3 trial was an international, randomized study of either aspirin (100mg/day) or placebo with vitamin-K antagonist (VKA) therapy in advanced heart failure patients newly implanted with Abbott's HeartMate 3 LVAD (ages 18 and older). The study found that HeartMate 3 patients who didn’t receive aspirin but continued using the standard post-implant VKA treatment regimen met the primary endpoint by showing non-inferiority of no aspirin to aspirin.

ARIES-HM3试验是一项针对阿司匹林（100mg/天）或安慰剂联合维生素K拮抗剂（VKA）治疗新植入雅培HeartMate 3 LVAD（18岁及以上）的晚期心力衰竭患者的国际随机研究。。

The HeartMate 3 patients who did not take aspirin spent 47% fewer days in the hospital due to a nearly 40% decrease in bleeding events compared to patients who continued to take aspirin daily. The data also found this same group had no elevated risk in developing thrombosis (a blood clot that increases the risk of stroke)..

没有服用阿司匹林的HeartMate 3患者住院天数减少了47%，因为与每天继续服用阿司匹林的患者相比，出血事件减少了近40%。。。

About Abbott

关于雅培

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries..

雅培（Abbott）是一家全球医疗保健领导者，致力于帮助人们在生命的各个阶段都生活得更加充实。我们的生命改变技术组合涵盖了医疗保健领域，在诊断、医疗器械、营养品和品牌仿制药领域拥有领先的业务和产品。我们的114000名同事为160多个国家的人民服务。