Economic Outcomes and Cost-Effectiveness of TAVR for Asymptomatic Severe Aortic Stenosis: Results from the EARLY TAVR Trial

EARLY TAVR economics

Patient / Population Intervention / Exposure Comparison Outcome

In patients with asymptomatic severe aortic stenosis, early TAVI had similar 5-year costs and was projected to be cost-effective over a lifetime compared with clinical surveillance.

N

901patients

Design

Economic analysis of EARLY TAVR, the randomised trial of TAVR versus clinical surveillance in asymptomatic severe aortic stenosis (Edwards; 77 sites in the US and Canada; primary results N Engl J Med 2025)

Endpoint

Medical costs and cost-effectiveness

ResultThe 5-year cumulative cost was $86,572 with TAVI vs $85,044 with clinical surveillance (P=0.60). Over a lifetime, early TAVR was predicted to increase cost by about $4,500 and to gain about 0.3 quality-adjusted life-years, an incremental cost-effectiveness ratio of $14,698 per QALY gained, with a 91.3% probability of TAVI being cost-effective. In the surveillance arm, TAVI followed in 25% by 6 months, 70% by 2 years and 95% by 5 years. In a sensitivity analysis, TAVI remained highly cost-effective even at 10 years.

Butala NM, et al. Presented at TCT 2026, 1 November. Reported by TCTMD (CRF). Not yet published.

Discussion & critique

Within the trial, early TAVI did not cost significantly more than clinical surveillance over 5 years, largely because nearly all surveillance patients eventually underwent TAVI. The lifetime cost-effectiveness result rests on extrapolation beyond the observed follow-up, so it depends on modelling assumptions as much as on trial data. The report gives no confidence intervals for costs or QALYs and no figures for the societal perspective. The source is a news report of a conference presentation, not a peer-reviewed paper, and the trial was funded by Edwards Lifesciences.