TRISCEND II: Novel Randomized Trial Design for Transcatheter Tricuspid Valve Replacement.

Area of Science:

• Cardiovascular Medicine
• Interventional Cardiology
• Medical Device Technology

Background:

• Severe tricuspid regurgitation (TR) is often undertreated due to limited therapeutic options.
• Transcatheter tricuspid valve interventions are emerging as a viable treatment for symptomatic severe TR.
• The TRISCEND II trial addresses the need for robust evidence in transcatheter tricuspid valve replacement (TTVR).

Purpose of the Study:

• To evaluate the safety and effectiveness of the EVOQUE transcatheter tricuspid valve replacement system.
• To serve as the first randomized controlled trial (RCT) for transcatheter tricuspid valve replacement (TTVR).
• To assess TTVR in conjunction with optimal medical therapy versus optimal medical therapy alone for severe TR.

Main Methods:

• Prospective, multicenter, randomized controlled trial design.
• Two-phase study evaluating 30-day safety and 6-month effectiveness (Phase 1), followed by 1-year outcomes (Phase 2).
• Enrolled 400 patients with symptomatic severe tricuspid regurgitation, randomized to TTVR + optimal medical therapy or optimal medical therapy alone.

Main Results:

• The trial's design facilitated early review and led to the first commercial approval of a TTVR system.
• Demonstrated the feasibility and potential benefits of TTVR in a randomized setting.
• Established endpoints for safety and effectiveness for future transcatheter tricuspid device trials.

Conclusions:

• The TRISCEND II trial provides crucial data on transcatheter tricuspid valve replacement for severe TR.
• The trial's innovative two-phase design influenced regulatory pathways and device approval.
• The methodology and findings of TRISCEND II are expected to guide future research in transcatheter tricuspid interventions.