Among patients undergoing tricuspid transcatheter edge-to-edge repair, TRILUMINATE-eligible patients had significantly lower mortality/rehospitalization compared to ineligible patients (12% vs 25%, p=0.028).
Cohort (n=664)
Does eligibility for TRILUMINATE and Tri.Fr trials predict mortality and rehospitalization in real-world patients undergoing T-TEER?
Around half of real-world patients undergoing T-TEER meet the inclusion criteria for major trials (TRILUMINATE and Tri.Fr), and these eligible patients have significantly better clinical outcomes than ineligible patients.
Absolute Event Rate: 12% vs 25%
p-value: p=0.028
ABSTRACT Background Recent trials demonstrated that tricuspid transcatheter edge‐to‐edge repair (T‐TEER) is particularly effective for symptoms and quality of life improvement. However, its effect on prognosis is still unclear. Moreover, the applicability of trials inclusion/exclusion criteria has not been investigated. Aims The aim of the present study is to investigate the applicability of TRILUMINATE and Tri.Fr trials inclusion and exclusion criteria on real‐world patients from TRIVALVE registry, and to evaluate their effects on outcomes. Methods Patients undergoing T‐TEER were selected from the TRIVALVE registry and, according to inclusion and exclusion criteria, divided in four groups: TRILUMINATE eligible versus ineligible and Tri.Fr eligible versus ineligible patients. TRILUMINATE and Tri.Fr analysis were conducted separately. Results From a total of 664 patients of the TRIVALVE registry, 520 and 519 were included in the TRILUMINATE and Tri.Fr analysis, respectively. In particular, 240 patients (46%) met the TRILUMINATE criteria and 260 (50%) those of Tri.Fr. Baseline characteristics were significantly different between trials' eligible and ineligible patients. TRILUMINATE‐eligible patients showed significant lower mortality/rehospitalization compared to ineligible ones (12% vs. 25%, p = 0.028), as well as Tri.Fr‐eligible versus ineligible ones (15% vs. 22%, p = 0.007). Conclusions In patients with TR undergoing T‐TEER, inclusion and exclusion criteria of TRILUMINATE and Tri.Fr are applicable to around half of real‐world patients. Patients matching trials criteria have lower mortality/rehospitalization.
Russo et al. (2026) conducted a cohort in Tricuspid regurgitation (n=664). Eligibility for TRILUMINATE trial vs. Ineligibility for TRILUMINATE trial was evaluated on mortality/rehospitalization (p=0.028). Among patients undergoing tricuspid transcatheter edge-to-edge repair, TRILUMINATE-eligible patients had significantly lower mortality/rehospitalization compared to ineligible patients (12% vs 25%, p=0.028).