Patients undergoing transcatheter edge-to-edge repair (TEER) using the Triclip (Abbott) system for the treatment of tricuspid regurgitation (TR) were less likely to be hospitalised for recurrent heart failure than patients treated only with medical therapy after two years of follow-up, latest results from the TRILUMINATE pivotal trial have shown.
Presented by Saibal Kar (Los Robles Health System, Thousand Oaks, USA) during a late-breaking trial session at the 2025 American College of Cardiology (ACC) scientific session (29–30 March, Chicago, USA), the results suggest that improvements in TR severity and quality of life seen earlier in the trial were sustained out to two years in patients receiving Triclip.
A total of 572 patients (mean age 78 years, 60% women) in five countries (USA, Canada, Germany, Italy and Spain) were enrolled in the randomised trial, all with severe TR; 55.1% had severe heart failure symptoms despite receiving the best available medical therapy; 50% had tricuspid regurgitation rated as “torrential” (the highest level of severity on a five-level scale); and 23.8% had been hospitalized for heart failure within the previous year.
After the first year of the trial, patients in the medical therapy group were allowed to cross over to receive the device, with more than half (142 of 241 eligible patients) having done so.
Results presented by Kar demonstrated that the rate of heart failure hospitalisation was significantly lower in the treatment group compared to the control group (0.19 vs. 0.26 events/patient-year, p=0.02), whilst patients who switched over to TEER had a drop in heart failure hospitalisation after receiving the device (0.5 vs. 0.35 events/patient-year).
A significant reduction in TR to moderate or less (grade ≤ 2) was achieved in 84% of patients with the device versus 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.
The number of patient deaths and the number of patients who needed tricuspid valve surgery during the two-year follow-up period was similar in both groups. No patients in the TEER group experienced device embolization or thrombosis, Kar said
Patients who received TriClip achieved more than a 15-point improvement on average in the Kansas City Cardiomyopathy Questionnaire (KCCQ) score throughout follow-up, with patients in the crossover group achieved similar improvements in KCCQ score (+13 points on average) once implanted with the device.
TriClip is approved for use in more than 50 countries, including in the USA, Europe and Canada.
