TRILUMINATE Pivotal Trial Reports 1-Year Outcomes With Abbott's TriClip to Treat Tricuspid Regurgitation

March 4, 2023—The American College of Cardiology announced that the TRILUMINATE Pivotal trial of the TriClip device (Abbott) demonstrated that in patients with a poorly functioning tricuspid heart valve, using the device to repair the valve was safe and improved both the valve’s functioning and patients’ quality of life at 1 year compared with the best available medical therapy. However, the trial did not show any significant difference in survival or heart failure hospitalization.

The findings were presented by Paul Sorajja, MD, at ACC.23/WCC, the ACC's annual scientific session together with the World Congress of Cardiology held March 4-6, 2023, in New Orleans, Louisiana. The study was simultaneously published online by Dr. Sorajja, et al in The New England Journal of Medicine.

The TRILUMINATE Pivotal trial was designed to determine whether patients with isolated tricuspid regurgitation would benefit from transcatheter edge-to-edge repair (TEER) to place one or more clips on the tricuspid valve leaflets to prevent blood from leaking back into the right atrium.

"Patients with tricuspid regurgitation, when treated with TEER with the TriClip device, experienced significant improvements in quality of life,” commented Dr. Sorajja in the ACC press release. "In a patient population with a high symptom burden, this is a meaningful benefit."

The study was funded by Abbott, maker of the TriClip. Abbott also participated in site selection, trial management, data collection, and analyses of the data.

In the ACC press release, the TRILUMINATE Pivotal investigators advised that the ongoing, international, randomized clinical trial is the first to evaluate the impact of improved tricuspid valve functioning on survival, heart failure hospitalizations, and quality of life in patients with tricuspid valve regurgitation.

Dr. Sorajja noted that the best available medical therapy for tricuspid regurgitation consists of diuretic medications that reduce fluid buildup in the body but often do not directly treat the mechanical leakage of blood through the tricuspid valve. As a result, he said, patients with tricuspid regurgitation usually have poor quality of life.

The TRILUMINATE Pivotal trial was composed of both a randomized cohort in which patients were randomly assigned either (1) to receive TEER—or to continue with the best available medical therapy—or (2) to a single-arm cohort in which all patients received TEER.

Patients deemed highly likely to achieve a reduction in tricuspid regurgitation to moderate or less were enrolled in the randomized trial; those deemed to have a low likelihood of achieving this level of reduction were enrolled in the single-arm trial, in which all patients were treated with TEER. The current study reports the results of the randomized trial.

As summarized in the ACC press release, the randomized trial enrolled a total of 350 patients (median age, 78 years; 55% women) in five countries (the United States, Canada, Germany, Italy, and Spain). All patients had severe tricuspid regurgitation and heart failure symptoms despite receiving the best available medical therapy; 51% had tricuspid regurgitation rated as “torrential” (the highest level of severity on a five-level scale).

Most patients also had either atrial fibrillation or high blood pressure or both. In addition, all patients were at intermediate or higher risk for complications from tricuspid valve surgery. Patients who had severe left ventricular heart failure, untreated other valvular disease, or severe pulmonary hypertension were not eligible to enroll.

Patients continued to take all their tricuspid regurgitation medications while in the study. Half of the patients were randomly assigned to have a TriClip device placed in the tricuspid valve. The other half did not undergo this procedure and served as a control group.

The study’s primary endpoint was a combination of death or tricuspid valve surgery, hospitalization for heart failure, and quality-of-life improvement of at least 15 points on a validated scale at 1 year.

Secondary endpoints included a reduction in tricuspid regurgitation to moderate or less at 30 days; absence of major adverse events including death with a cardiovascular cause, new onset of kidney failure, or the need for surgery because of a problem with the TriClip device; change in quality-of-life score at one year; and change in the distance patients could walk in 6 minutes at 1 year.

The investigators found that after 1 year of follow-up, patients in the TEER group saw significant improvements in quality-of-life scores (average increase of 12.3 points) compared with control patients (average increase of one point). However, the primary endpoint was not met because there were no significant differences between the TEER and control groups in the number of deaths from any cause or the rate of hospitalization for heart failure. At 30 days, 87% of patients undergoing TEER had moderate or less tricuspid regurgitation, compared with 4.8% of those in the control group.

Three patients (1.7%) had a major adverse event at 30 days (one death due to a cardiovascular cause and two cases of new kidney failure). Nine patients treated with TEER (5.2%) experienced a major bleeding event within 1 year. Five patients in the TEER group (2.9%) and five in the control group (2.9%) needed surgery to implant a permanent pacemaker or defibrillator within 1 year.

Dr. Sorajja advised that one limitation of the study is that it was unblinded. However, independent experts who were blinded to patient treatment assessed the hospitalizations, deaths, and other adverse events that occurred in the study. In addition, the study findings are limited to patients with tricuspid regurgitation features deemed more amenable to a reduction in regurgitation to moderate or less.

The TRILUMINATE Pivotal trial will continue to follow the patients for 5 years, stated the ACC press release.