Tricuspid regurgitation (TR), a debilitating condition, is often associated with a low quality of life (QoL) and significant morbidity.¹ The standard diuretic and surgical therapy is restricted to a small number of patients and is frequently associated with a high operative risk.¹ Transcatheter edge-to-edge repair (TEER) for TR patients has emerged as a therapy, but its clinical benefit vs. medical therapy alone remains unknown.¹ In the American College of Cardiology (ACC) Scientific Session/World Congress of Cardiology (WCC) 2023, Dr. Paul Sorajja, on behalf of the TRILUMINATE Pivotal investigators, shared the results of their study on the efficacy and safety of TEER in symptomatic patients with severe TR.¹ 

TRILUMINATE Pivotal was a prospective, randomized controlled, multicenter clinical trial designed to evaluate the safety and effectiveness of the TriClip™ device in symptomatic patients with severe TR who are at the intermediate or greater estimated risk of mortality with surgery.¹ This trial included patients with severe symptomatic TR, stable guideline-directed medical therapy (GDMT) and/or device therapy for heart failure (HF) for ≥30 days, and ≥intermediate risk of mortality/morbidity with tricuspid valve (TV) surgery.¹ In contrast, patients with indication for other valve disease intervention, severe pulmonary hypertension (HTN), left ventricular ejection fraction (LVEF) ≤20%, and anatomy not suitable for the TriClip™ therapy were excluded.¹ 

The trial enrolled >450 patients from up to 80 centers across the United States (US), Canada, and Europe.1 Among them, 350 were randomized to receive either TEER (n=175) or medical therapy (n=175).¹ Patients in both groups were 78 years old on average, with 55% being female.¹ Patients undergoing the investigational TEER procedure were administered general anesthesia and the procedure was performed through the femoral vein.¹ The TriClip™ device permanently opposes the leaflets of TV, thereby reducing TR.¹ At the 1-year follow-up, the primary endpoint was a hierarchical composite of death from any cause or TV surgery, hospitalization for HF, and an improvement in QoL as measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ), with improvement defined as an increase of ≥15 points in the KCCQ score (ranged 0-100, with higher scores indicating better QoL).¹ The researchers also examined the absence of major adverse events (MAEs) and the reduction of TR to moderate or less at 30 days post-procedure as the secondary endpoints.¹ 

The overall results of the primary endpoint favored the TEER group (win ratio: 1.48; 95% CI: 1.06-2.13; p=0.02).¹ Compare with the rate of hospitalization for HF and the incidence of death or TV surgery, the superiority of the TriClip™ therapy to medical therapy was driven by the significant improvement in KCCQ.¹ In the TEER group, the KCCQ QoL score changed by a mean [± standard deviation (SD)] of 12.3 ± 1.8 points, whereas it changed by a mean (± SD) of 0.6 ± 1.8 points in the control group (p<0.001).¹ TR was reduced by the TriClip™ therapy to moderate or less severity in 87% vs. only 4.8% for the control group at 30 days (p<0.0001), and the reduction was sustained after a 1-year follow-up.¹ Researchers noted that at 30 days, 98.3% of patients who underwent the TEER procedure were free of MAEs, while pacemaker implantation occurred in only 0.6% of TEER patients.¹ At 1 year, both groups had a high rate of survival free of mortality and surgery (~90%).¹ 

In conclusion, TRILUMINATE Pivotal was a groundbreaking study, which was also the first randomized controlled trial in this distinct population of severe TR.¹ At 1 year, the TriClip™ device was highly effective in reducing TR, leading to significant improvements in QoL without the high procedural risk that was typically associated with tricuspid surgery.¹ With the excellent benefit-to-risk profile of the TriClip™ system, a previously untreated population will now have a treatment option to enhance their QoL.¹ "Patients with TR, when treated with TEER with the TriClip™ device, experienced significant improvements in QoL," said Dr. Sorajja, the lead author of the study, stating that, "In a patient population with a high symptom burden, this is a meaningful benefit."¹