Health ArticleEducational review — not personal medical advice

Catheter-Based Tricuspid Valve Repair Improves Survival and Reduces Hospitalizations in Severe Heart Valve Leakage

In a randomized trial, 360 patients had symptomatic severe tricuspid regurgitation.

21 min
Original medical illustration for: Catheter-Based Tricuspid Valve Repair Improves Survival and Reduces Hospitalizations in Severe Heart Valve Leakage

Table of Contents

Key Points

  • In a trial of 360 patients with symptomatic severe tricuspid regurgitation, transcatheter valve repair plus medical therapy was superior to medical therapy alone.
  • At 3 years, 52.4% of the repair group were alive and free from heart-failure hospitalization, compared with 21.0% of the medical-therapy group.
  • The win ratio for the combined measure of death, heart-failure hospitalization, and quality-of-life improvement at 1 year was 2.42.
  • Major adverse events within 30 days occurred in 14 patients (5.9%) in the repair group; one death occurred 17 days after the procedure.
  • The number needed to treat to prevent one death or heart-failure hospitalization in 1 year was 4.

Background: Why This Research Matters

Tricuspid regurgitation is linked to increased illness and death. In tricuspid regurgitation, the tricuspid valve on the right side of the heart does not close properly. This allows blood to leak backward. Treatment options using medication alone have been limited. Isolated tricuspid-valve surgery (open-heart surgery to repair or replace just this valve) is rarely performed because the surgical risk is high.

Transcatheter tricuspid-valve interventions (catheter-based procedures that repair the valve through a vein without open surgery) have emerged as an alternative to surgery. Among these, tricuspid edge-to-edge repair is the most widely adopted technique. It is associated with high procedural success and a favorable safety profile.

Before this study, two randomized controlled trials had compared transcatheter tricuspid-valve repair with medical therapy alone. Both showed improvements in quality of life. However, neither trial showed clear reductions in heart-failure hospitalization or death at 1 year. A more recent analysis suggested that 2-year outcome data might show reductions in heart-failure hospitalization. But the low number of events in both trials limited the ability to determine the true benefits of transcatheter valve repair.

Because of these uncertainties, the effect of transcatheter tricuspid-valve repair in patients at increased risk for heart-failure events remained unclear. The TRIC-I-HF trial was designed to answer this question directly. It tested whether transcatheter tricuspid-valve repair plus medical therapy would result in a lower risk of death and hospitalization for heart failure than medical therapy alone. The study enrolled patients with severe tricuspid regurgitation who were at increased risk for future heart-failure events.

How the Study Was Conducted

TRIC-I-HF was an investigator-initiated, prospective, multicenter, open-label, randomized, controlled strategy trial. "Investigator-initiated" means the doctors and researchers who designed the study were not employees of a device company. "Open-label" means both patients and doctors knew which treatment was given. "Randomized" means patients were assigned to treatment groups by chance, like flipping a coin.

The trial was conducted at 29 high-volume heart-valve centers in Germany. Participating centers had substantial experience in transcatheter tricuspid-valve repair. On average, each center had performed 176±163 procedures before the trial began.

The trial was conducted in accordance with the principles of the Declaration of Helsinki (an international set of ethical standards for medical research). All participants provided written informed consent. The trial was approved by the responsible ethics committees.

Patients were randomly assigned in a 2:1 ratio to one of two groups:

  • Tricuspid-repair group: transcatheter tricuspid-valve repair plus medical therapy
  • Medical-therapy group: medical therapy alone

Randomization was conducted in permuted blocks. This means patients were assigned in small groups to keep the two treatment arms balanced. The assignment was stratified according to trial site and severity of tricuspid regurgitation. Stratification ensures that each group has a similar mix of patients from each hospital and with each severity level.

Transcatheter valve repair was recommended to be performed within 14 days after randomization. Clinical follow-up in both groups was conducted at 1 month and 12 months. After that, annual visits continued up to 3 years, with a window of ±6 weeks. For this analysis, follow-up was completed, with the last randomly assigned patient reaching the 12-month follow-up visit.

Patient selection and enrollment were at the discretion of the local heart team. There was no need for approval by a central eligibility committee or screening for baseline medical treatment. To be eligible, patients had to have at least severe tricuspid regurgitation on a five-grade scale (mild, moderate, severe, massive, and torrential). This had to persist despite medical therapy including diuretic therapy adjusted to the individual optimal dose for at least 30 days.

Patients were considered to be at advanced risk for future heart-failure events if they met either of two criteria. The first criterion was a history of decompensation (worsening of heart failure requiring treatment) in the previous 12 months. The second criterion was the presence of a cardiorenal or cardiohepatic syndrome. In these patients with heart failure, cardiorenal syndrome was defined as chronic kidney disease. Chronic kidney disease was defined as an estimated glomerular filtration rate below 60 ml per minute per 1.73 m² of body-surface area. The estimated glomerular filtration rate is a measure of kidney function. Cardiohepatic syndrome was defined by elevated levels of at least two of three laboratory markers of cholestasis (a condition where bile flow is blocked): bilirubin, alkaline phosphatase, and γ-glutamyltransferase.

The presence of advanced risk of future heart-failure events was added to the protocol as an additional inclusion criterion in July 2023. All patients underwent preprocedural right heart catheterization (a procedure that measures pressures inside the heart chambers) to allow comprehensive hemodynamic characterization and selection based on previously identified cutoff values.

Crossover from medical therapy to transcatheter tricuspid-valve repair was permitted only if all of the following criteria were met:

  1. At least 30 days had elapsed since randomization
  2. A heart-failure decompensation had resulted in hospitalization
  3. Intravenous diuretic therapy was administered during that hospitalization

Accordingly, crossover was allowed only after a patient had had a primary end-point event. Any subsequent hospitalization for the crossover procedure was not counted as an additional end-point event.

Statistical analysis: For the first primary end point, researchers calculated that a sample size of 224 patients in the tricuspid-repair group and 112 patients in the medical-therapy group (a total of 336 patients) would provide 85% power. This calculation assumed a win ratio of 1.818 and a significance level of 5% for a two-sided test. It also assumed that the proportion of wins would be 0.4, the proportion of losses would be 0.22, and the proportion of ties would be 0.38. For the second coprimary end point, researchers assumed an incidence of 45% in the medical-therapy group and 30% in the tricuspid-repair group. Assuming a two-sided significance level of 5%, a power of 90%, and a 2:1 randomization ratio, they calculated that 324 patients would be required. To account for anticipated dropouts, the target sample size was increased to 360 patients.

All analyses were conducted according to the intention-to-treat principle in the full analysis population, which included all patients who underwent randomization. The two primary end points were tested in a hierarchical manner in a closed testing procedure. This means the second primary end point was tested only if the first one showed a significant difference. The first primary end point was evaluated by means of the Finkelstein–Schoenfeld method and summarized as a win ratio with corresponding 95% confidence intervals. If the difference in the win-ratio analysis was significant, the second coprimary end point would be analyzed. The second coprimary end point would be analyzed with the use of a two-sided log-rank test. The two-sided log-rank test would compare event-free survival between trial groups. Kaplan–Meier methods and stratified Cox proportional-hazards models were used to estimate event-free survival and hazard ratios with 95% confidence intervals. Both tests were two-sided at a significance level of 0.05 and stratified according to the severity of tricuspid regurgitation for the main analysis. There were no interim efficacy analyses. No adjustments for multiplicity were performed for secondary end points.

Who Participated in the Study

From March 2022 through June 2025, a total of 360 patients underwent randomization. Of these, 237 patients were assigned to the tricuspid-repair group and 123 patients to the medical-therapy group.

The mean (±SD) age of the patients was 80.3±6.4 years, with a range of 53 to 92 years. Women made up 56.4% of the participants. Baseline characteristics were well balanced between the two groups. The trial population reflected patients at increased risk for future heart-failure events.

Key baseline characteristics included:

  • 75.0% had New York Heart Association (NYHA) class III or IV heart failure (moderate to severe limitation of physical activity due to heart failure symptoms)
  • 55.0% had been hospitalized for heart failure in the previous year
  • 81.7% had cardiorenal syndrome (kidney dysfunction related to heart failure)
  • 46.2% had cardiohepatic syndrome (liver dysfunction related to heart failure)
  • 92.0% in the repair group and 97.6% in the medical-therapy group had atrial fibrillation or flutter (irregular heart rhythms)
  • 25.3% in the repair group and 26.0% in the medical-therapy group had diabetes mellitus
  • 79.3% in the repair group and 82.1% in the medical-therapy group had arterial hypertension (high blood pressure)
  • 46.4% in the repair group and 55.3% in the medical-therapy group had coronary artery disease

At baseline, tricuspid regurgitation was graded as severe in 50.8% of patients, massive in 34.2%, and torrential in 10.3%. The mean left ventricular ejection fraction (a measure of how well the left side of the heart pumps) was 54.3±8.6%.

Medical therapy for right heart failure included:

  • Loop diuretics (water pills) in 94.2% of patients, with a median daily dose of 80 mg
  • Sodium–glucose cotransporter 2 inhibitors (a class of medication that helps the heart and kidneys) in 52.2%
  • Mineralocorticoid receptor antagonists (medications that block a hormone that worsens heart failure) in 43.1%

The median EuroSCORE II score was 4.3 (interquartile range, 2.9 to 6.2) in the repair group. The median EuroSCORE II score was 4.2 (interquartile range, 2.8 to 7.9) in the medical-therapy group. EuroSCORE II is a measure of predicted risk of death after cardiac surgery, ranging from 1 to 100%, with higher scores indicating greater risk. The median TRI-SCORE was 4.0 (interquartile range, 3.0 to 6.0) in the repair group. The median TRI-SCORE was 5.0 (interquartile range, 4.0 to 6.0) in the medical-therapy group. TRI-SCORE is a measure of risk after isolated tricuspid-valve surgery, ranging from 0 to 12, with higher scores indicating greater risk.

The median N-terminal pro–B-type natriuretic peptide (NT-proBNP) was 2022 pg/ml (interquartile range, 1229 to 3283) in the repair group. The median NT-proBNP was 2076 pg/ml (interquartile range, 1195 to 4066) in the medical-therapy group. NT-proBNP is a blood marker of heart failure severity. The mean Kansas City Cardiomyopathy Questionnaire (KCCQ) score was 51.9±22.3 in the repair group. The mean KCCQ score was 52.4±23.5 in the medical-therapy group. The KCCQ score is a measure of quality of life, ranging from 0 to 100, with higher scores indicating better health status. The mean 6-minute walk distance was 240.1±128.4 meters in the repair group and 233.4±117.8 meters in the medical-therapy group.

What the Procedure Involved

Among the 231 patients who underwent transcatheter tricuspid therapy, the specific procedures were:

  • 227 patients (98.3%) were scheduled to undergo transcatheter edge-to-edge repair (a technique that clips the valve leaflets together to reduce leakage)
  • 3 patients (1.3%) underwent transcatheter annuloplasty (a technique that reshapes the valve ring)
  • 1 patient (0.4%) underwent transcatheter tricuspid-valve replacement (a deviation from the trial protocol)

The local heart-valve team selected from devices that had received a European Certificate of Conformity (known as the CE mark) for transcatheter tricuspid-valve repair. The choice was based on what was suitable for the individual patient. The commercially available CE-marked devices included the PASCAL system and the Cardioband system (both from Edwards Lifesciences) and the TriClip system (from Abbott Cardiovascular).

Of those undergoing edge-to-edge repair, 149 patients (65.6%) received the PASCAL system and 75 patients (33.0%) received the TriClip system. At least one device was implanted in all these patients. The number of devices implanted was one in 28.6% of patients, two in 62.1%, and three or more in 9.4%.

Key Findings: What the Study Showed

Follow-up was completed in 93.5% of eligible patients at 1 year, 58.3% at 2 years, and 20.5% at 3 years. The mean follow-up interval was 594±323 days in the tricuspid-repair group and 567±351 days in the medical-therapy group.

First primary end point: The first primary end point was a hierarchical composite of death from any cause, hospitalization for heart failure, and quality-of-life improvement at 12 months. Quality-of-life improvement was assessed using the KCCQ, with a clinically meaningful improvement defined as an increase of at least 15 points.

For this first primary hierarchical end point at 1 year after randomization, 16,909 wins were observed in the tricuspid-repair group and 6,966 wins in the medical-therapy group, with 5,276 ties. This corresponded to a win ratio of 2.42 (95% confidence interval [CI], 1.76 to 3.33; P<0.001) in favor of tricuspid repair. A win ratio of 2.42 means that patients in the repair group were more than twice as likely to have a better outcome than patients in the medical-therapy group. The result was statistically highly significant (P<0.001), meaning there is less than a 0.1% chance this finding was due to random chance.

The interventional strategy showed consistently more wins across all components of the primary end point:

  • Death from any cause: 4,366 wins in the repair group vs. 3,166 wins in the medical-therapy group
  • Hospitalization for heart failure: 9,280 wins vs. 2,871 wins
  • Improvement of at least 15 points in the KCCQ score: 3,263 wins vs. 929 wins

Second primary end point: Because the win-ratio analysis showed a significant difference, the second primary end point was analyzed. This was a composite of death from any cause or hospitalization for heart failure, assessed in a time-to-event analysis at a minimum follow-up of 12 months.

Kaplan–Meier estimates for event-free survival (the percentage of patients alive and free from heart-failure hospitalization) were:

  • At 1 year: 73.9% in the tricuspid-repair group vs. 48.4% in the medical-therapy group
  • At 3 years: 52.4% (95% CI, 43.2 to 63.6) in the tricuspid-repair group vs. 21.0% (95% CI, 12.7 to 34.6) in the medical-therapy group

This corresponded to a hazard ratio of 0.40 (95% CI, 0.29 to 0.55; P<0.001). A hazard ratio of 0.40 means that patients in the repair group had a 60% lower risk of death or heart-failure hospitalization compared with the medical-therapy group. This result was also statistically highly significant.

In a post hoc analysis (an analysis performed after the study was completed), the number needed to treat to prevent one death or hospitalization for heart failure with tricuspid-valve repair in 1 year was 4 (95% CI, 3 to 6). This means that for every 4 patients treated with tricuspid-valve repair, one death or heart-failure hospitalization was prevented within 1 year.

Individual components of the primary end point:

For death from any cause, the Kaplan–Meier estimates for survival were:

  • At 1 year: 86.5% in the tricuspid-repair group vs. 82.5% in the medical-therapy group
  • At 3 years: 72.3% in the tricuspid-repair group vs. 53.9% in the medical-therapy group (hazard ratio, 0.62; 95% CI, 0.40 to 0.96)

For hospitalization for heart failure, the estimated percentage of patients who were alive and free from hospitalization was:

  • At 1 year: 79.6% in the tricuspid-repair group vs. 51.3% in the medical-therapy group (hazard ratio, 0.35; 95% CI, 0.25 to 0.50)
  • At 3 years: 62.4% in the tricuspid-repair group vs. 31.0% in the medical-therapy group (hazard ratio, 0.35; 95% CI, 0.25 to 0.51)

Tricuspid repair was also associated with a lower cumulative incidence of hospitalization for heart failure when researchers accounted for the competing risk of death. There was no evidence of a violation of the proportional-hazards assumption (a statistical assumption that the treatment effect remains constant over time).

Secondary end points: The severity of tricuspid regurgitation at 30 days was moderate or less in 135 of 192 patients (70.3%) in the tricuspid-repair group, compared with 29 of 98 patients (29.6%) in the medical-therapy group. The corresponding percentages for mild tricuspid regurgitation or less at 1 year were 56.3% in the repair group and 19.2% in the medical-therapy group.

Tricuspid repair was associated with substantial improvement in NYHA functional class at 1 year. NYHA class I or II heart failure was reported in 138 of 187 patients (73.8%) in the tricuspid-repair group. NYHA class I or II heart failure was reported in 49 of 86 patients (57.0%) in the medical-therapy group. NYHA class I or II heart failure means no or mild limitation of physical activity.

The mean change in the KCCQ score from baseline to 1-year follow-up was 11.2±21.9 points (95% CI, 8.0 to 14.5) in the tricuspid-repair group and 4.3±24.9 points (95% CI, −1.1 to 9.6) in the medical-therapy group.

Safety and Side Effects

Major adverse events occurred in 14 patients (5.9%) within 30 days after tricuspid transcatheter-valve repair. One death occurred 17 days after the procedure.

In total, 48 patients crossed over from the medical-therapy group to receive transcatheter tricuspid-valve repair. Crossover was permitted only after a primary end-point event involving hospitalization for severe heart failure that required intravenous diuretic therapy. In 28 of 48 crossovers (58%), the valve-repair procedure was performed during the hospitalization that constituted the primary end-point event. The remaining crossover procedures were performed during subsequent hospitalizations.

What This Means for Patients

This trial provides strong evidence that transcatheter tricuspid-valve repair plus medical therapy is superior to medical therapy alone. This is in patients with symptomatic severe tricuspid regurgitation. These patients are at increased risk for heart-failure events. The benefits were consistent across multiple measures.

The findings showed that the interventional strategy was superior with respect to:

  • A hierarchical composite of death from any cause, hospitalization for heart failure, and quality-of-life improvement at 1 year
  • A lower risk of the composite of death from any cause or hospitalization for heart failure through 3 years

The number needed to treat of 4 is particularly striking. It means that for every 4 patients treated with transcatheter tricuspid-valve repair, one death or heart-failure hospitalization was prevented within 1 year. This is a strong treatment effect for a condition that previously had limited options.

The procedure also led to meaningful improvements in valve function. At 30 days, 70.3% of patients in the repair group had moderate or less tricuspid regurgitation, compared with 29.6% in the medical-therapy group. By 1 year, 56.3% of repair-group patients had mild or less regurgitation, compared with 19.2% in the medical-therapy group.

Patients in the repair group also reported better quality of life. The mean KCCQ score improved by 11.2 points in the repair group, compared with 4.3 points in the medical-therapy group. The KCCQ is a questionnaire that measures how heart failure affects daily life, including symptoms, physical limitations, and social function.

More patients in the repair group improved to NYHA class I or II heart failure (73.8% vs. 57.0%). This means they experienced no or mild limitation of physical activity, compared with more significant limitations before treatment.

Limitations of the Study

The trial had several limitations that patients and doctors should consider.

First, the trial was open-label, meaning both patients and doctors knew which treatment was given. This could potentially influence how patients reported their symptoms and quality of life. However, the hard outcomes of death and hospitalization are less likely to be affected by this knowledge.

Second, follow-up was completed in only 20.5% of eligible patients at 3 years. This means the 3-year results are based on a smaller number of patients than the 1-year results. The long-term benefits beyond 3 years remain unknown.

Third, the trial was conducted at 29 high-volume heart-valve centers in Germany. These centers had substantial experience in transcatheter tricuspid-valve repair, with a mean of 176±163 procedures before the trial began. Results may differ at centers with less experience.

Fourth, the trial population was predominantly White (82.3% in the repair group and 82.1% in the medical-therapy group). Whether the results apply equally to other racial and ethnic groups is not known.

Fifth, no adjustments for multiplicity were performed for secondary end points. This means the confidence intervals for secondary end points should not be used to infer definitive treatment effects.

Sixth, the trial used a hierarchical composite end point that included quality-of-life improvement. This type of end point gives priority to death, then hospitalization, then quality of life. While this approach is increasingly used in heart failure trials, it means that improvements in quality of life can contribute to a positive result. This can happen even if death and hospitalization rates were similar. In this trial, however, the repair group showed benefits across all components.

Recommendations and Next Steps

Based on the results of this trial, patients with symptomatic severe tricuspid regurgitation who are at increased risk for heart-failure events may benefit from transcatheter tricuspid-valve repair plus medical therapy. The procedure was associated with a 60% lower risk of death or heart-failure hospitalization through 3 years.

Patients who are considering this procedure should discuss the following with their heart team:

  1. Whether they meet the criteria for severe tricuspid regurgitation despite optimal medical therapy
  2. Whether they have markers of increased risk for heart-failure events, such as a history of decompensation in the previous 12 months or cardiorenal or cardiohepatic syndrome
  3. The risks and benefits of the procedure, including the 5.9% rate of major adverse events within 30 days
  4. The expected benefits, including a number needed to treat of 4 to prevent one death or heart-failure hospitalization in 1 year
  5. The availability of CE-marked devices, including the PASCAL system, the Cardioband system, and the TriClip system

The trial was funded by the German Center for Cardiovascular Research and others. The trial is registered on ClinicalTrials.gov with the number NCT04634266.

Future research should focus on longer-term outcomes beyond 3 years, the effectiveness of the procedure at centers with less experience, and whether the results apply to more diverse patient populations. Additionally, further studies are needed to determine which patients benefit most from transcatheter tricuspid-valve repair and which patients may do well with medical therapy alone.

Frequently Asked Questions

What is transcatheter tricuspid-valve repair?

It is a catheter-based procedure to fix a leaky tricuspid valve on the right side of the heart without open surgery. In a trial of 360 patients with symptomatic severe tricuspid regurgitation, most (98.3%) had edge-to-edge repair, which clips the valve leaflets together to reduce leakage. The heart team chose among CE-marked devices suitable for each patient.

Who was eligible for this trial?

Patients had at least severe tricuspid regurgitation on a five-grade scale that persisted despite medical therapy, including diuretics adjusted to the individual optimal dose for at least 30 days. They also had to be at increased risk for future heart-failure events, meaning a history of decompensation in the previous 12 months or a cardiorenal or cardiohepatic syndrome.

What did the trial find about survival and hospitalizations?

In 360 patients with symptomatic severe tricuspid regurgitation, at 3 years 52.4% of those who had valve repair plus medical therapy were alive and free from heart-failure hospitalization, compared with 21.0% who had medical therapy alone. This corresponded to a 60% lower risk of death or heart-failure hospitalization in the repair group.

What does a win ratio of 2.42 mean?

The win ratio compared a combined measure of death, heart-failure hospitalization, and quality-of-life improvement at 1 year. A win ratio of 2.42 means patients in the repair group were more than twice as likely to have a better outcome than those in the medical-therapy group. The result was statistically highly significant.

What are the risks of the procedure?

In the trial, major adverse events within 30 days occurred in 14 of 237 patients (5.9%) in the repair group, and one death occurred 17 days after the procedure. Patients considering this procedure should discuss the risks and benefits with their heart team, including this 5.9% rate of major adverse events within 30 days.

What is the number needed to treat of 4?

In a post hoc analysis, the number needed to treat to prevent one death or hospitalization for heart failure with tricuspid-valve repair in 1 year was 4. This means that for every 4 patients treated with transcatheter tricuspid-valve repair, one death or heart-failure hospitalization was prevented within 1 year.

What improvements in symptoms and quality of life were seen?

At 1 year, 73.8% of patients in the repair group had NYHA class I or II heart failure, meaning no or mild limitation of physical activity, compared with 57.0% in the medical-therapy group. The mean KCCQ quality-of-life score improved by 11.2 points in the repair group versus 4.3 points with medical therapy alone.

When should a patient with symptomatic severe tricuspid regurgitation seek a second opinion about transcatheter tricuspid-valve repair?

A second opinion is reasonable when a patient has symptomatic severe tricuspid regurgitation despite at least 30 days of adjusted diuretic therapy, and has markers of increased heart-failure risk such as a decompensation in the previous 12 months or cardiorenal or cardiohepatic syndrome. In a randomized trial, transcatheter tricuspid-valve repair plus medical therapy was superior to medical therapy alone, with a hazard ratio of 0.40 for death or heart-failure hospitalization through 3 years and a number needed to treat of 4 at 1 year. Diagnostic Detectives Network provides independent expert second opinions.

Source Information

Original article title: Tricuspid-Valve Intervention in Heart Failure

Authors: Jörg Hausleiter, M.D., Thomas J. Stocker, M.D., Tobias Geisler, M.D., Philipp Lurz, M.D., Ph.D., Wolfgang Rottbauer, M.D., Edith Lubos, M.D., Niklas Schofer, M.D., Christian Frerker, M.D., Johanne Frank, M.D., Holger Thiele, M.D., Rico Osteresch, M.D., Volker Rudolph, M.D., Alexander Lauten, M.D., Erion Xhepa, M.D., Jürgen Rothe, M.D., Tienush Rassaf, M.D., Stephan Baldus, M.D., Georg Nickenig, M.D., David M. Leistner, M.D., Eike Tigges, M.D., Victoria Kehl, Ph.D., Mirjam Kessler, M.D., Tobias Kister, M.D., Tobias Ruf, M.D., Muhammed Gerçek, M.D., Meinrad Gawaz, M.D., Derk Frank, M.D., Ingo Eitel, M.D., Ralph Stephan von Bardeleben, M.D., Daniel Kalbacher, M.D., Osama Soliman, M.D., Ph.D., Michael Näbauer, M.D., and Steffen Massberg, M.D., for the TRIC-I-HF-DZHK24 Investigators

Publication: The New England Journal of Medicine

Publication date: August 30, 2026

DOI: 10.1056/NEJMoa2606934

ClinicalTrials.gov number: NCT04634266

Funding: German Center for Cardiovascular Research and others

This patient-friendly article is based on peer-reviewed research.