This international open-label trial randomised 744 patients with moderate aortic stenosis to TAVR or clinical surveillance. Each had at least one at-risk feature, a symptom or abnormality linked to faster progression or adverse outcomes. Mean age was 78 years, 39.1% were women, and TAVR used a transfemoral balloon-expandable valve. At 2 years, death or heart failure occurred in 16.7% with TAVR versus 23.9% with surveillance (difference -7.2 points). Heart-failure events were 10.8% versus 19.0%, and deaths from any cause 8.4% versus 7.3%. The main limitation is the open-label design, and the trial was funded by Edwards Lifesciences.
Why it is interesting: Current guidelines recommend repeat heart scans every 1 or 2 years for moderate aortic stenosis, and this trial tests TAVR instead. Over 2 years the benefit came from fewer heart-failure events, not fewer deaths.
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