TRILUMINATE™ Pivotal data presented at the American College of Cardiology's Annual Scientific Session (ACC.25) and simultaneously published in

TRILUMINATE™ 关键数据在美国心脏病学会年度科学会议（ACC.25）上发表，并同时发布于

Circulation

循环

show the Abbott TriClip system reduces heart failure hospitalizations

显示Abbott TriClip系统减少心力衰竭住院人数

The latest results highlight significant improvements in tricuspid regurgitation and quality of life through two years

最新结果显示，通过两年的时间，三尖瓣反流和生活质量均有显著改善。

ABBOTT PARK

雅培公园

, Ill.

，病态。

,

，

March 31, 2025

2025年3月31日

/

/

PRNewswire

美通社

/ -- Abbott (NYSE: ABT) today announced late-breaking data from its TRILUMINATE™ Pivotal trial that show the TriClip™ transcatheter edge-to-edge repair (TEER) system to treat tricuspid regurgitation (TR), or a leaky heart valve, offers substantial and sustained improvements in the severity of TR after two years.

/ -- 雅培（Abbott，纽约证券交易所代码：ABT）今天公布了其TRILUMINATE™ 关键试验的最新数据，数据显示，使用TriClip™ 经导管缘对缘修复（TEER）系统治疗三尖瓣反流（TR），或称心脏瓣膜渗漏，在两年后显著且持续地改善了TR的严重程度。

The results also demonstrate the TriClip device significantly reduced the rate of hospitalizations due to heart failure compared to medical therapy, while offering long-term quality-of-life benefits for patients..

结果还表明，与药物治疗相比，TriClip 设备显著降低了因心力衰竭导致的住院率，同时为患者提供了长期的生活质量益处。

TR can reduce the amount of blood being pumped through the body and force the heart to work harder than it should, causing debilitating symptoms such as fatigue and shortness of breath. When left untreated, TR can lead to atrial fibrillation, heart failure and, ultimately, death. For those who are not good candidates for surgery and continue to have symptoms or persistent TR despite treatment with medical therapy, TriClip represents a needed option that can improve a person's quality-of-life and keep them out of the hospital..

三尖瓣反流会减少泵入身体的血液量，迫使心脏超负荷工作，导致疲劳和呼吸急促等症状。如果不治疗，三尖瓣反流会导致心房颤动、心力衰竭，并最终导致死亡。对于不适合手术且尽管接受药物治疗仍然有症状或持续性三尖瓣反流的患者，TriClip代表了一种必要的选择，可以改善患者的生活质量并避免住院。

The data were presented at the American College of Cardiology's Annual Scientific Session (ACC.25) held in

数据在美国心脏病学会年度科学会议（ACC.25）上公布，会议于

Chicago

芝加哥

(

(

March 29-31

3月29日至31日

, 2025) and simultaneously published in

，2025年）并同时发表于

Circulation

循环

.

。

Sustained Benefits for Patients With Severe Leaky Heart Valve

严重漏诊心瓣膜病患者的持续受益

After two years, the TRILUMINATE Pivotal study found TriClip continued to demonstrate superiority compared to medical therapy while meeting the secondary endpoints of recurrent heart failure hospitalizations (HFH) and freedom from all-cause mortality, tricuspid valve surgery and tricuspid valve intervention.

两年后，TRILUMINATE Pivotal 研究发现，与药物治疗相比，TriClip 仍然表现出优越性，同时达到了次要终点，即复发性心力衰竭住院（HFH）和免于全因死亡率、三尖瓣手术及三尖瓣干预。

After the first year of the trial, patients in the control group (medical therapy) were allowed to cross over to receive TriClip therapy, and more than half (142 of 241 eligible patients) received TriClip..

在试验的第一年后，对照组（药物治疗）的患者被允许跨组接受TriClip治疗，超过一半的患者（241名符合条件的患者中有142名）接受了TriClip治疗。

Additional positive two-year findings from the TRILUMINATE Pivotal trial include:

TRILUMINATE 关键试验的其他两年阳性结果包括：

Significant reduction in HFH.

HFH显著减少。

The rate of HFH was significantly lower in the treatment group compared to the control group (0.19 vs. 0.26 events/patient-year, p=0.02). Also, control patients who switched to TriClip treatment had a drop in HFH after receiving the device (0.5 vs. 0.35 events/patient-year).

治疗组的 HFH 发生率显著低于对照组（0.19 vs. 0.26 事件/患者年，p=0.02）。此外，转用 TriClip 治疗的对照组患者在接受装置后 HFH 也有所下降（0.5 vs. 0.35 事件/患者年）。

Significant, sustained reduction in TR grade.

显著且持续的TR等级降低。

Significant reduction in TR to moderate or less (grade ≤ 2) was achieved in 84% of patients with the device vs. 21% of patients in the control group. Similar improvements were seen in the control group patients who crossed over, with 81% of patients achieving moderate or less TR at 30 days after receiving TriClip compared to 3% prior to crossing over..

使用该装置的患者中，84%的患者TR显著减少至中度或更低（等级≤2），而对照组中仅有21%的患者达到相同效果。对照组中交叉接受治疗的患者也表现出类似的改善，30天后接受TriClip治疗的患者中有81%达到了中度或更低的TR，而交叉前这一比例仅为3%。

Significant, sustained improvement in quality of life.

显著且持续的生活质量改善。

Patients who received TriClip achieved more than a 15-point improvement on average in the Kansas City Cardiomyopathy Questionnaire (KCCQ) score (a self-assessment of social abilities, symptoms and quality of life) throughout follow-up. Patients in the crossover group achieved similar improvements in KCCQ score (+13 points on average) once implanted with TriClip..

接受TriClip治疗的患者在整个随访期间，堪萨斯城心肌病问卷（KCCQ）评分（一种对社会能力、症状和生活质量的自我评估）平均提高了超过15分。而交叉组的患者在植入TriClip后，KCCQ评分也获得了类似的改善（平均提高13分）。

'With the TRILUMINATE Pivotal two-year results, tricuspid transcatheter edge-to-edge repair with the TriClip device for severe, symptomatic tricuspid regurgitation reduced heart failure hospitalizations compared to the control group. Improvements in tricuspid regurgitation severity and quality of life were sustained through two years,' said Saibal Kar, M.D., Los Robles Regional Medical Center in .

“TRILUMINATE Pivotal两年研究结果显示，与对照组相比，使用TriClip装置进行三尖瓣经导管缘对缘修复术治疗重度症状性三尖瓣反流可减少心力衰竭住院率。三尖瓣反流严重程度和生活质量的改善在两年内得以持续，”洛杉矶罗布尔斯地区医疗中心的Saibal Kar博士表示。

Thousand Oaks, California

加利福尼亚州千橡市

. 'When we combine this with the consistent quality-of-life improvements people who receive the TriClip system experience, it's clear that the benefits for patients with TR are very meaningful and TriClip offers a safe, effective and sustainable way to repair the tricuspid valve.'

“当我们把这一结果与接受TriClip系统治疗的患者生活质量持续改善相结合时，很明显，对于TR患者来说，这些益处非常显著，而TriClip提供了一种安全、有效且可持续的三尖瓣修复方法。”

'These new data reinforce the critical role TriClip plays in helping people with tricuspid regurgitation live the life they want while reducing the risk of hospitalization,' said Sandra Lesenfants, senior vice president of Abbott's structural heart business. 'Patients battling TR face serious challenges, including increased risk of heart failure, as a result of this debilitating condition.

“这些新数据证实了TriClip在帮助三尖瓣反流患者过上他们想要的生活的同时降低住院风险方面所起的关键作用，”雅培结构性心脏病业务高级副总裁桑德拉·莱森凡茨表示。“患有三尖瓣反流的患者面临着严峻的挑战，包括因这种衰弱性疾病而导致的心力衰竭风险增加。”

Unfortunately, many are not eligible for open-heart surgery and had limited treatment options prior to the approval of TriClip, a significant advancement that allows patients to reclaim their lives.'.

不幸的是，许多患者不符合开胸手术的条件，在TriClip获批之前，他们的治疗选择非常有限。TriClip是一项重要的技术进步，它让患者能够重获新生。

About the Abbott TRILUMINATE Pivotal Trial

关于雅培TRILUMINATE关键试验

The TRILUMINATE Pivotal trial is the first randomized, controlled clinical study to evaluate the safety and effectiveness of transcatheter repair with the TriClip system compared to medical therapy alone in people with severe TR. The primary endpoint was a composite of all-cause mortality or tricuspid valve surgery, heart failure hospitalizations, and quality-of-life improvement measured by the KCCQ score.

TRILUMINATE Pivotal试验是首个随机对照临床研究，旨在评估TriClip系统经导管修复术与单独药物治疗相比在严重三尖瓣反流（TR）患者中的安全性和有效性。主要终点是由全因死亡率或三尖瓣手术、心力衰竭住院以及通过KCCQ评分衡量的生活质量改善组成的复合指标。

.

。

TriClip is approved for use in more than 50 countries, including in the U.S.,

TriClip 已获准在包括美国在内的 50 多个国家使用，

Europe

欧洲

and Canada.

和加拿大。

For U.S. important safety information on TriClip, visit

有关 TriClip 的美国重要安全信息，请访问

https://abbo.tt/TriClip_ISI

https://abbo.tt/TriClip_ISI

.

。

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..

Abbott是一家全球医疗保健领域的领导者，帮助人们在生命的各个阶段更充实地生活。我们改变生命的技术组合涵盖了整个医疗保健领域，在诊断、医疗器械、营养品和品牌仿制药方面拥有领先的业务和产品。我们的114,000名员工为超过160个国家的人们提供服务。

Connect with us at

通过以下方式联系我们

www.abbott.com

www.abbott.com

and on

并且

LinkedIn

领英

,

，

Facebook

脸书

,

，

Instagram

Instagram

,

，

X

X

and

和

YouTube

YouTube

.

。

SOURCE Abbott

来源 雅培