Summary
This international multicentre randomised controlled trial compared transcatheter tricuspid valve replacement combined with medical therapy against medical therapy alone in 400 patients with severe symptomatic tricuspid regurgitation. The valve replacement strategy demonstrated superiority on a hierarchical composite outcome at 1 year, with a win ratio of 2.02 in favour of intervention, driven primarily by improvements in symptom burden and functional status. However, the intervention was associated with significantly higher rates of severe bleeding (15.4% versus 5.3%), warranting careful patient selection and risk stratification.
UK applicability
The findings are directly relevant to United Kingdom cardiology practice, as transcatheter tricuspid valve replacement is increasingly available in NHS centres. The results support expansion of this percutaneous option for symptomatic patients with severe tricuspid regurgitation who are at high surgical risk, though the bleeding risk profile requires careful consideration in clinical decision-making.
Key measures
Win ratio (2.02 at 1 year); mortality rates (14.8% vs 12.5%); repeat intervention (3.2% vs 0.6%); Kansas City Cardiomyopathy Questionnaire overall summary score improvement (23.1% vs 6.0%); NYHA functional class improvement (10.2% vs 0.8%); 6-minute walk distance improvement (1.1% vs 0.9%); heart failure hospitalisation annualised rate (9.7% vs 10.0%); severe bleeding (15.4% vs 5.3%)
Outcomes reported
The study measured a hierarchical composite primary outcome including mortality, device implantation or transplantation, repeat valve intervention, heart failure hospitalisation, and improvements in symptom scores and functional capacity at 1 year. Secondary outcomes included rates of severe bleeding and new permanent pacemaker implantation.
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