TRISCEND II Trial: Late-Breaking PCR London Valves 2024 - EMJ

TRISCEND II Trial: Late-Breaking PCR London Valves 2024

TRANSCATHETER tricuspid-valve replacement significantly improves outcomes in patients with severe tricuspid regurgitation, enhancing quality of life and symptom relief compared to medical therapy alone, according to recent research presented at PCR London Valves 2024.

Severe tricuspid regurgitation presents a substantial clinical challenge due to its association with disabling symptoms and increased mortality. The effectiveness of percutaneous transcatheter tricuspid-valve replacement compared to standard medical therapy has remained unclear. To address this gap, an international, multicenter trial assessed outcomes for patients with severe symptomatic tricuspid regurgitation, focusing on a composite of mortality, interventions, functional status, and quality-of-life improvements.

The study randomly assigned 400 patients to either transcatheter tricuspid-valve replacement combined with medical therapy or medical therapy alone, using a 2:1 ratio. The hierarchical composite primary outcome incorporated six measures, including death from any cause, tricuspid-valve interventions, and functional and quality-of-life improvements. At one year, the valve-replacement group demonstrated a win ratio of 2.02 (95% CI: 1.56 to 2.62; p<0.001), indicating superior performance. The group also achieved significant benefits in functional outcomes: improvements in Kansas City Cardiomyopathy Questionnaire scores (23.1% vs. 6.0%), New York Heart Association functional class (10.2% vs. 0.8%), and six-minute walk distance (1.1% vs. 0.9%). However, adverse events were notable, including a higher incidence of severe bleeding (15.4% vs. 5.3%) and new permanent pacemaker implantation (17.4% vs. 2.3%).

These findings highlight the potential of transcatheter tricuspid-valve replacement as an effective intervention for improving quality of life and functional capacity in patients with severe tricuspid regurgitation. However, the increased risk of severe bleeding and pacemaker dependency requires consideration in clinical practice. Future research should explore patient selection strategies to optimise outcomes and evaluate long-term benefits. For clinicians, these results provide compelling evidence to consider valve replacement as part of a tailored management strategy, particularly for patients experiencing profound symptom burdens.

Reference

Hahn R et al. TRISCEND II: transcatheter valve replacement vs. medical therapy for tricuspid regurgitation. NEJM. 2024;DOI:10.1056/NEJMoa2401918.

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