Why is the study important?   

The TRISCEND II Trial demonstrated that at 1 year, the transcatheter tricuspid valve replacement (TTVR) using the Evoque system combined with optimal medical therapy improved symptoms, function, and quality of life compared to optimal medical therapy alone. Furthermore, there were numerically lower deaths and fewer heart failure hospitalizations in patients who underwent TTVR.   

Should I change my practice because of these findings?   

The overall performance of the Evoque TTVR system in the TRISCEND II appears to demonstrate favorable early safety, with meaningful improvements in symptoms for these higher-risk patients with limited options. There is a clear unmet clinical need, and imaging requirements for TTVR appear to be less than with transcatheter edge-to-edge, potentially favoring reproducibility for Heart Teams going forward. Additional data will be required to demonstrate whether or not numerical mortality and heart failure admission gains become significant with longer follow-ups.  

What question was the study supposed to answer?   

This study sought to compare 1-year outcomes in TTVR using the Evoque system combined with optimal medical therapy compared to optimal medical therapy alone and was able to demonstrate significant improvements in symptoms, function, and quality of life with a signal towards improvements in mortality and heart failure admissions.  

What did the study show?   

The study enrolled 400 patients (n=267 for TTVR and n=133 for optimal medical therapy alone) across 45 international sites. Early events were higher in the TTVR cohort, with a cardiovascular mortality of 3.1% at 30 days compared to 0% in the optimal medical therapy cohort. Additionally, TTVR saw severe bleeding in 10.4% of patients and 24.7% required a new permanent pacemaker or implantable defibrillator cardioverter. The 1-year analysis of patients enrolled in the multicenter randomized controlled trial demonstrated that the win ratio favored TTVR (2.02; 95% CI 1.56-2.62) with marked improvements in 1-year symptoms, function, and quality of life. All-cause mortality occurred in 12.6% of TTVR patients and in 15.2% of optimal medical therapy patients at 1 year. The landmark analysis demonstrated that after 1 month, mortality rates were 9.4% and 15.2% respectively.  

How good was the approach/methodology?   

The TRISCEND II Trial was a large and well-designed multicenter randomized controlled trial seeking to demonstrate the safety and efficacy of the Evoque TTVR system. One of the major limitations was that there was no sham arm in the study, and additional follow-up will be required to elucidate additional gains in symptom relief and possibly mortality.