Hot Line: New evidence for the benefits of TEER in secondary tricuspid regurgitation
01 Sep 2024
Professor Erwan Donal (Hospital of Rennes - Rennes, France) explained why the Tri.fr trial was conducted: “Patients with severe secondary tricuspid regurgitation (TR) often have reduced quality of life (QoL) and a poor prognosis, with many ineligible for surgery due to the associated risks. In common with others, we were interested in exploring tricuspid transcatheter edge-to-edge repair (T-TEER) as a new treatment option and we conducted the investigator-led Tri.fr trial to test this approach on top of optimal medical therapy.”
This open-label randomised trial was conducted in patients who had symptomatic, severe secondary TR despite medical management, were stable for at least 30 days and were ineligible for surgical correction. Participants were randomised to receive either T-TEER in addition to optimal medical treatment or optimal medical treatment alone.
The primary endpoint was the Packer composite score (combining NYHA class, patient global assessment [PGA] and major CV events: all-cause mortality, cardiovascular mortality, tricuspid valve surgery, heart failure [HF] hospitalisations, CV and non-CV hospitalisations).
The trial included 300 patients recruited from France and Belgium. The mean age was 78 years and 54% were women. In total, 40% had been hospitalised for HF within 1 year before enrolment and 15% had a cardiac implantable electronic device.
The clinical composite score improved in the T-TEER vs. control group (74.1% vs. 40.6%, respectively; p<0.0001).
After 1 year, the severity of TR significantly improved in the intervention vs. the control group: the probability of a better TR grade (ordinal variable <4+, 4+ or 5+) was 0.73 (95% CI 0.68–0.78Íž p<0.0001). Lower rates of hospitalisation and death were observed in the T-TEER group, although the trial was not designed to detect statistically significant differences in these outcomes.
The overall Kansas City Cardiomyopathy Questionnaire score at 1-year follow-up was 69.9 (SD 25.5) with the intervention compared with 55.4 (SD 28.8) in the control group (p<0.0001). Three-quarters of patients (74.6%) in the T-TEER group compared with 39.5% in the control group had an improved PGA.
“We clearly showed the benefits of T-TEER, as seen in the TRILUMINATE trial,1 but using T-TEER as part of a global approach and treating HF with guideline-directed medical management and follow-up. A key message of the Tri.fr trial is that implementing rigorous multidisciplinary medical management resulted in a low event rate, even in very ill patients with secondary TR. Using T-TEER with optimal medical management also led to important QoL improvements. It remains to be seen if patients with a particular phenotype of severe TR derive more benefit from T-TEER than others. We expect to provide more insightful outcomes data in the coming years as we continue to follow-up the trial participants,” concluded Prof. Donal.
References
- Sorajja P, et al. N Engl J Med. 2023;388:1833–1842.
