WASHINGTON--(BUSINESS WIRE)--Edwards Lifesciences (NYSE: EW) today announced results from the EARLY TAVR Trial, the first randomized, controlled trial designed to study the best strategy for treating asymptomatic severe aortic stenosis (AS) and the benefits of early intervention with transcatheter aortic valve replacement (TAVR).

华盛顿-（商业新闻）-爱德华兹生命科学公司（纽约证券交易所：EW）今天宣布了早期TAVR试验的结果，这是第一个随机对照试验，旨在研究治疗无症状严重主动脉瓣狭窄（AS）的最佳策略以及经导管主动脉瓣置换术（TAVR）早期干预的益处。

The trial results demonstrated that asymptomatic severe AS patients randomized to Edwards TAVR experienced superior outcomes compared with guideline-recommended clinical surveillance. Trial investigators presented the data today during a late-breaking clinical trials session at Transcatheter Cardiovascular Therapeutics (TCT), the annual scientific symposium of the Cardiovascular Research Foundation (CRF) and published simultaneously in The New England Journal of Medicine..

试验结果表明，与指南推荐的临床监测相比，随机分配到Edwards TAVR的无症状严重AS患者的预后更好。试验研究人员今天在心血管研究基金会（CRF）年度科学研讨会Transcather Cardiovascular Therapeutics（TCT）的一次最新临床试验会议上介绍了这些数据，并同时发表在《新英格兰医学杂志》上。。

With a median follow up of 3.8 years, the data demonstrated superiority of early TAVR, with 26.8% of the 455 patients in the TAVR arm experiencing death, stroke or unplanned cardiovascular hospitalization compared to 45.3% of the 446 patients in the clinical surveillance arm. Additionally, the data showed that early intervention with TAVR:.

中位随访时间为3.8年，数据显示早期TAVR的优越性，TAVR组455例患者中有26.8%经历了死亡，中风或意外心血管住院治疗，而临床监测组446例患者中有45.3%。此外，数据显示，TAVR的早期干预：。

Prevented unpredictable and rapid progression of symptoms, which sometimes resulted in emergent intervention and/or hospitalization;

防止不可预测和快速的症状进展，有时会导致紧急干预和/或住院治疗；

Prevented clinically meaningful and rapid decline in quality of life; and

防止临床上有意义的生活质量迅速下降；和

Resulted in numerically lower rate of stroke for patients with early TAVR (4.2% vs. 6.7% at a median follow-up time of 3.8 years).

导致早期TAVR患者的卒中发生率在数值上较低（中位随访时间为3.8年，分别为4.2%和6.7%）。

“What we learned in this trial is that without intervention, patients rigorously confirmed as asymptomatic experienced unpredictable and rapid decline with numerous adverse outcomes. These results shatter 60 years of ingrained belief on the treatment for severe aortic stenosis, with guidelines that currently recommend ‘watchful waiting’ for intervention until symptoms develop,” said Philippe Genereux, MD, director of the structural heart program at Gagnon Cardiovascular Institute, Morristown Medical Center, Morristown, New Jersey.

新泽西州莫里斯敦莫里斯敦医学中心加农心血管研究所结构性心脏计划主任Philippe Genereux医学博士说：“我们在这项试验中了解到，如果不进行干预，被严格确认为无症状的患者会经历不可预测的快速下降，并出现许多不良后果。这些结果打破了60年来对严重主动脉瓣狭窄治疗的根深蒂固的信念，目前的指南建议在症状出现之前进行“警惕性等待”干预。”。

“With no demonstrated clinical penalty for TAVR, these trial results strongly support a change to the practice and current guidelines for the treatment of aortic stenosis patients.”.

“由于TAVR没有明显的临床惩罚，这些试验结果强烈支持改变主动脉瓣狭窄患者的治疗实践和现行指南。”。

The EARLY TAVR Trial enrolled 901 patients – with an average age of 76 and average KCCQ-OS score of 92.7 – at 75 sites across the US and Canada. Patients were rigorously confirmed as asymptomatic through a protocol-mandated stress test – a first in TAVR trials – and medical history evaluation. Designed specifically to evaluate if early intervention is a better strategy than clinical surveillance, the EARLY TAVR Trial showed that within the first six months, a striking 26.2% of patients in the clinical surveillance arm converted to aortic valve replacement (AVR) with many presenting progressive or advanced symptoms.

早期TAVR试验在美国和加拿大的75个地点招募了901名患者，平均年龄为76岁，平均KCCQ-OS评分为92.7。通过协议规定的压力测试（TAVR试验中的首次）和病史评估，患者被严格确认为无症状。早期TAVR试验旨在评估早期干预是否比临床监测更好，早期TAVR试验显示，在前六个月内，临床监测组中惊人的26.2%的患者转为主动脉瓣置换术（AVR），其中许多患者表现为进行性或晚期症状。

In the 12-month follow-up period after randomization, the rate of conversion to AVR was 47.2%..

在随机分组后的12个月随访期间，AVR的转换率为47.2%。。

“This is the first pivotal trial to generate evidence about the best strategy for disease management of severe aortic stenosis,” said Larry Wood, Edwards’ corporate vice president and group president, transcatheter aortic valve replacement and surgical structural heart. “EARLY TAVR challenges the current standard of care by definitively showing that patients who don’t have symptoms of severe aortic stenosis have a deadly disease that requires urgent treatment.”.

爱德华兹公司副总裁兼经导管主动脉瓣置换术和结构性心脏手术集团总裁拉里·伍德（LarryWood）说：“这是第一个关键性试验，旨在为严重主动脉瓣狭窄的疾病管理提供最佳策略的证据。”。“早期TAVR通过明确显示没有严重主动脉瓣狭窄症状的患者患有致命疾病，需要紧急治疗，从而挑战了当前的护理标准。”。

About Edwards Lifesciences

关于爱德华兹生命科学

Edwards Lifesciences is the leading global structural heart innovation company, driven by a passion to improve patient lives. Through breakthrough technologies, world-class evidence and partnerships with clinicians and healthcare stakeholders, our employees are inspired by our patient-focused culture to deliver life-changing innovations to those who need them most.

爱德华兹生命科学公司是全球领先的结构性心脏创新公司，致力于改善患者生活。通过突破性的技术、世界一流的证据以及与临床医生和医疗保健利益相关者的合作，我们的员工受到以患者为中心的文化的启发，为最需要的人提供改变生活的创新。

Discover more at www.edwards.com and follow us on LinkedIn, Facebook, Instagram and YouTube..

请访问www.edwards.com了解更多信息，并在LinkedIn、Facebook、Instagram和YouTube上关注我们。。

This news release includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. We intend the forward-looking statements contained in this release to be covered by the safe harbor provisions of such Acts.

本新闻稿包括经修订的《1933年证券法》第27A节和经修订的《1934年证券交易法》第21E节所指的前瞻性声明。我们打算将本版本中包含的前瞻性声明纳入此类法案的安全港条款。

These forward-looking statements can sometimes be identified by the use of forward-looking words, such as “may,” “might,” “believe,” “will,” “expect,” “project,” “estimate,” “should,” “anticipate,” “plan,” “goal,” “continue,” “seek,” “intend,” “optimistic,” “aspire,” “confident” and other forms of these words and include, but are not limited to, statements made by Mr.

这些前瞻性陈述有时可以通过使用前瞻性词语来识别，例如“可能”、“可能”、“相信”、“将”、“期望”、“项目”、“估计”、“应该”、“预期”、“计划”、“目标”、“继续”、“寻求”、“打算”、“乐观”、“渴望”、“自信”和这些词语的其他形式，包括但不限于先生的陈述。

Wood and statements regarding expected product benefits, patient outcomes, objectives and expectations and other statements that are not historical facts. Forward-looking statements are based on estimates and assumptions made by management of the company and are believed to be reasonable, though they are inherently uncertain and difficult to predict.

伍德和关于预期产品益处、患者结果、目标和期望的陈述以及其他非历史事实的陈述。前瞻性陈述基于公司管理层做出的估计和假设，虽然它们本身不确定且难以预测，但被认为是合理的。

Our forward-looking statements speak only as of the date on which they are made, and we do not undertake any obligation to update any forward-looking statement to reflect events or circumstances after the date of the statement. Investors are cautioned not to unduly rely on such forward-looking statements..

我们的前瞻性声明仅在发布之日起生效，我们没有义务更新任何前瞻性声明以反映声明日期后的事件或情况。提醒投资者不要过度依赖此类前瞻性声明。。

Forward-looking statements involve risks and uncertainties that could cause results to differ materially from those expressed or implied by the forward-looking statements based on a number of factors as detailed in the company's filings with the Securities and Exchange Commission. These filings, along with important safety information about our products, may be found at Edwards.com..

前瞻性陈述涉及风险和不确定性，这些风险和不确定性可能导致结果与基于公司向证券交易委员会提交的文件中详述的许多因素的前瞻性陈述所明示或暗示的结果存在重大差异。这些文件以及有关我们产品的重要安全信息可以在爱德华兹网站上找到。。

Edwards, Edwards Lifesciences, the stylized E logo, and EARLY TAVR are trademarks of Edwards Lifesciences Corporation. All other trademarks are the property of their respective owners.

Edwards、Edwards Lifesciences、stylized E徽标和早期TAVR是Edwards Lifesciences Corporation的商标。。