TRILUMINATE– Transcatheter edge-to-edge repair reduces TR severity and HF Hospitalizations

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By Inbar McCarthy on

Key Points

  • The TRILUMINATE Pivotal trial previously reported that transcatheter edge-to-edge repair (TEER) improved quality-of-life compared to medical therapy alone for severe, symptomatic tricuspid regurgitation. The trial did not observe a benefit in mortality or heart failure hospitalization at 1-year but differences may emerge with longer follow-up. 
  • In this 2-year pre-specified analysis, TEER significantly decreased the annualized rate of heart failure hospitalizations through 2 years compared to the control arm (0.19 vs 0.26 events/patient year, p=0.02). No difference in all-cause mortality was observed. 

Severe tricuspid regurgitation is associated with significant morbidity and mortality for which transcatheter edge-to-edge repair (TEER) has emerged as a new treatment option. In the TRILUMINATE pivotal trial, TEER, with the TriClip Transcatheter Tricuspid Valve Repair System, improved health status at 1-year without significant reductions in heart failure hospitalization (HFH) or mortality at that timepoint. However, longer follow-up may be required before differences in these endpoints emerge and 2-year endpoints were therefore pre-specified. 

TRILUMINATE Pivotal randomized 572 patients with symptomatic severe or greater tricuspid regurgitation and intermediate or high surgical risk in a 1:1 ratio to tricuspid TEER with the TriClip device plus medical therapy or medical therapy alone. Prespecified secondary endpoints included recurrent HFH and freedom from all-cause mortality, tricuspid valve surgery, and tricuspid valve intervention at 2-years. Key exclusion criteria include indication for other valve disease intervention, severe pulmonary hypertension, severely impaired left ventricular ejection fraction, or anatomy not amenable to device placement.  The average age of the study population was 78 years, approximately 59% were women, and approximately half had torrential tricuspid regurgitation.  

TEER reduced the relative risk of annualized HFH by 28% compared to the control arm (HR 0.72 [0.53, 0.98], p=0.04); the annualized rate of recurrent HFH through 2 years was 0.19 vs 0.26, p=0.02. Freedom from all-cause mortality, tricuspid valve surgery, and tricuspid valve intervention post-index procedure through 2 years was significantly higher in the TEER group as compared to the control group (77.6% [95% CI: 72.2%, 82.1%] vs 29.3% [95% CI: 23.8%, 34.9%], p<0.0001). All-cause mortality was similar at 2-years in the TEER (17.9%) and control (17.1%) groups. Health status improvements with TEER were sustained at the 2-year interval with a 15.4±23.4-point improvement in the Kansas City Cardiomyopathy Questionnaire (KCCQ) relative to baseline.

In conclusion, tricuspid TEER reduced the annualized rate of HFH and improved health status after 2 years, though did not reduce all-cause mortality. The authors note that the outcomes of the TRILUMINATE pivotal trial represent the longest follow up period to date for a randomized control trial investigating tricuspid TEER.