Why is this study important?

This is the first study evaluating transcatheter tricuspid valve replacement (TTVR) in an RCT setting. 1-year follow-up showed superiority of Evoque TTVR over medical therapy alone in patients with symptomatic severe TR

What question was this study supposed to answer?

• To compare the 2-year efficacy and safety of the Evoque TTVR system with medical therapy alone in patients with symptomatic severe TR.
• 400 patients with symptomatic severe TR were randomized to either Evoque TTVR or medical therapy alone.
• ​Median age was 79 years. The majority of patients were female (76%). About two-thirds of patients had NYHA III/IV symptoms.  More than 90% of patients had atrial fibrillation. 39% of patients had a history of pacemaker/CIED. 

What did the study show?​

• At 2 years, there was significant reduction in TR; 95% patients in TTVR arm had mild or less TR. There was also sustained improvement in symptoms compared with medical therapy alone.
• There was no difference in all-cause mortality between TTVR and control arm.
• There was significant reduction in all-case mortality (19% vs 44.9%) and HF hospitalizations (26.8% vs 37.1%) among patients who underwent TTVR (including crossovers from control arm) compared with patients in the control arm who did not undergo TTVR. 
• There was no significant difference in severe bleeding at 2 years however, patients in TTVR arm had increased risk of needing a new pacemaker as compared with control arm. 

Key takeaways

• In the TRISCEND-II study, Evoque TTVR resulted in a significant reduction of TR and sustained improvement in symptoms at 2-year follow-up.
• Although there was no mortality benefit in the main analysis, patients who underwent TTVR, including crossover, had a reduction in mortality and HF hospitalization as compared with patients who did not undergo TTVR.