New Late-Breaking Data Reinforce Benefits of Abbott's TriClip™ for People With Leaky Tricuspid Heart Valve

Rhea-AI Summary

Abbott (NYSE: ABT) announced positive two-year data from its TRILUMINATE™ Pivotal trial for the TriClip™ transcatheter edge-to-edge repair (TEER) system, designed to treat tricuspid regurgitation (TR). The results, presented at ACC.25 and published in Circulation, demonstrate significant improvements over medical therapy.

Key findings after two years include:

• Significant reduction in heart failure hospitalizations (0.19 vs. 0.26 events/patient-year) in the treatment group
• 84% of TriClip patients achieved moderate or less TR grade versus 21% in control group
• Patients showed over 15-point improvement in quality of life scores (KCCQ)
• More than half of control group patients (142 of 241) crossed over to receive TriClip therapy, showing similar improvements

The data confirms TriClip as a safe and effective treatment option for TR patients who are not suitable for open-heart surgery, offering sustained benefits in reducing valve leakage and improving quality of life.

Positive

• Significant reduction in heart failure hospitalizations (0.19 vs 0.26 events/patient-year)
• 84% of patients achieved reduction in TR to moderate or less vs 21% in control group
• Sustained quality of life improvements with 15+ point increase in KCCQ scores
• Strong efficacy demonstrated by high crossover rate (142 of 241 control patients)

Negative

• None.

Insights

Medical Device Expert

The 2-year TRILUMINATE Pivotal trial data for Abbott's TriClip system represents significant clinical validation for this minimally invasive treatment for tricuspid regurgitation. The results demonstrate substantial benefits with 84% of TriClip patients achieving moderate or lower TR grade compared to just 21% in the medical therapy group. This dramatic improvement in valve function translated to meaningful clinical outcomes, with TriClip reducing heart failure hospitalizations (0.19 vs. 0.26 events/patient-year, p=0.02).

What's particularly compelling is the crossover data - when control patients later received TriClip, they experienced similar TR reduction (from 3% to 81% achieving moderate or less TR) and quality-of-life improvements. This creates a powerful internal validation of the device's effectiveness. The sustained quality-of-life benefit (>15-point KCCQ improvement) addresses a critical unmet need for symptomatic TR patients who aren't surgical candidates.

Publication in Circulation and presentation at ACC.25 adds significant credibility to these findings. For a structural heart device, this combination of sustained clinical improvement, reduced hospitalizations, and quality-of-life benefits positions TriClip as a potentially practice-changing therapy for the management of severe tricuspid regurgitation in non-surgical candidates.

Financial Analyst

These robust 2-year TRILUMINATE results significantly strengthen Abbott's position in the structural heart market. The demonstrated reduction in heart failure hospitalizations provides compelling health economic value that should drive insurance coverage and physician adoption. The hospitalization reduction (0.19 vs. 0.26 events/patient-year) carries particular weight with healthcare systems focused on reducing readmissions and managing costs.

Abbott's structural heart business represents an important growth pillar within their diversified portfolio. This segment delivers higher margins than some of their other divisions, making its success particularly relevant for profitability. TriClip addresses tricuspid regurgitation - a condition that has historically had treatment options - potentially opening a substantial market opportunity.

The data's publication in a premier cardiology journal while being presented at a major medical conference maximizes visibility among the key physician audience who make device selection decisions. The executive quote from Sandra Lesenfants, SVP of Abbott's structural heart business, underscores the strategic importance of TriClip within Abbott's portfolio. This continued clinical validation should help drive adoption among interventional cardiologists while strengthening Abbott's competitive differentiation in the structural heart space.

• TRILUMINATE™ Pivotal data presented at the American College of Cardiology's Annual Scientific Session (ACC.25) and simultaneously published in Circulation show the Abbott TriClip system reduces heart failure hospitalizations
• The latest results highlight significant improvements in tricuspid regurgitation and quality of life through two years

ABBOTT PARK, Ill., March 31, 2025 /PRNewswire/ -- 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. 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.

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.

The data were presented at the American College of Cardiology's Annual Scientific Session (ACC.25) held in Chicago (March 29-31, 2025) and simultaneously published in Circulation.

Sustained Benefits for Patients With Severe Leaky Heart Valve
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. 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.

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

• Significant reduction in HFH. 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).
• Significant, sustained reduction in TR grade. 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.
• Significant, sustained improvement in quality of life. 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.

"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 Thousand Oaks, California. "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."

"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. 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."

About the Abbott TRILUMINATE Pivotal Trial
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.  

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

For U.S. important safety information on TriClip, visit https://abbo.tt/TriClip_ISI. 

About Abbott
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.

Connect with us at www.abbott.com and on LinkedIn, Facebook, Instagram, X and YouTube. 

View original content:https://www.prnewswire.com/news-releases/new-late-breaking-data-reinforce-benefits-of-abbotts-triclip-for-people-with-leaky-tricuspid-heart-valve-302413554.html

SOURCE Abbott

FAQ

What are the 2-year results of Abbott's TriClip TRILUMINATE Pivotal trial for TR?

The trial showed 84% reduction in TR to moderate or less, decreased heart failure hospitalizations (0.19 vs 0.26 events/patient-year), and over 15-point improvement in quality of life scores compared to medical therapy.

How effective is Abbott's TriClip in reducing heart failure hospitalizations?

TriClip significantly reduced heart failure hospitalizations to 0.19 events/patient-year compared to 0.26 in the control group, with crossover patients showing improvement from 0.5 to 0.35 events/patient-year.

What percentage of patients achieved TR reduction with Abbott's TriClip device?

84% of TriClip patients achieved moderate or less TR grade, compared to 21% in the control group. In crossover patients, 81% achieved moderate or less TR within 30 days.

How did Abbott's TriClip impact patient quality of life in the TRILUMINATE trial?

Patients receiving TriClip showed more than 15-point improvement in KCCQ quality of life scores, with crossover patients achieving similar improvements (+13 points) after implantation.