Key result
Patients undergoing T-TEER who met TRILUMINATE or Tri.Fr eligibility criteria had significantly lower mortality/rehospitalization than ineligible patients (12% vs 25%, p=0.028; 15% vs 22%, p=0.007).
Why the study?
The effect of T-TEER on prognosis remains unclear, and the real-world applicability of major trial inclusion and exclusion criteria has not been investigated.
Does eligibility for major clinical trials (TRILUMINATE or Tri.Fr) predict lower mortality and rehospitalization in real-world patients undergoing T-TEER?
Observational (n=664)
Does eligibility for major clinical trials (TRILUMINATE or Tri.Fr) predict lower mortality and rehospitalization in real-world patients undergoing T-TEER?
Only about half of real-world patients undergoing T-TEER meet the inclusion criteria for major trials (TRILUMINATE, Tri.Fr), and these eligible patients experience significantly lower mortality and rehospitalization rates than their ineligible counterparts.
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.
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Russo et al. (2026) conducted an observational in Tricuspid regurgitation (n=664). TRILUMINATE trial eligibility vs. TRILUMINATE trial ineligibility was evaluated on Mortality/rehospitalization (p=0.028). Patients undergoing T-TEER who met TRILUMINATE or Tri.Fr eligibility criteria had significantly lower mortality/rehospitalization than ineligible patients (12% vs 25%, p=0.028; 15% vs 22%, p=0.007).
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