Transcatheter aortic valve replacement (TAVR) was shown to be non-inferior to surgical aortic valve replacement (SAVR) in terms of mortality in patients age 70 and older deemed to be at increased surgical mortality risk, according to late-breaking trial results presented Sunday at the American College of Cardiology Scientific Sessions 2020 virtual conference.
The UK TAVI trial was designed to assess the clinical effectiveness and cost-utility of TAVR, compared with SAVR, in patients age 70 years and older with severe, symptomatic aortic stenosis. The design was an open-label, non-inferiority, randomized controlled trial. The trial enrolled patients at intermediate or high surgical risk for mortality as determined by the multi-disciplinary heart team.
TAVR is also known as transcatheter aortic valve implantation (TAVI).
A total of 913 patients from 34 U.K. centers were randomized between TAVR and SAVR. William Toff, MD, a professor of clinical cardiology at the University of Leicester, U.K., stressed in presenting the results that the study had a pragmatic design with minimal exclusion criteria and took place in a real-world setting with all CE-marked TAVR valves allowed.
The primary endpoint was all-cause mortality at 1 year. The trial also measured several key secondary outcomes, including all-cause mortality at 2, 3, 4 and 5 years; stroke; and death from any cause or stroke.
Baseline characteristics were similar between the two arms, including mean age (TAVR 81.1 years, SAVR 81.0 years), male sex (TAVR 53.9%, SAVR 53.2%), and median Society of Thoracic Surgeons risk score (TAVR 2.6%, SAVR 2.7%).
At 1 year, all-cause death rates were similar between the two groups (TAVR 4.6% vs. SAVR 6.6%; hazard ratio [HR], 0.69; 95% confidence interval [CI], 0.38-1.26; p=0.23).
TAVR was associated with a significantly higher rate of vascular complications, (TAVR 4.8% vs. SAVR 1.3%; HR, 3.39; 95% CI, 1.79-7.60; p<0.001), higher rate of permanent pacemaker implantation (TAVR 12.2% vs. SAVR 6.6%; HR, 1.92; 95% CI, 1.33-2.76; p=0.02) and higher rate of aortic regurgitation (mild regurgitation, TAVR 38.3% vs. SAVR 11.7%; moderate regurgitation, TAVR 2.3% vs. SAVR 0.6%).
However, TAVR was associated with less major bleeding (TAVR 6.3% vs. SAVR 17.1%; HR, 0.34; 95% CI, 0.25-0.46; p<0.001), shorter hospital stay (TAVR 3 days vs. SAVR 8 days), fewer days in intensive care (TAVR 0 days vs. SAVR 1 day), and more rapid improvement in functional capacity and quality of life.
Toff concluded that non-inferiority of TAVR compared to SAVR was met in patients older than 70 years and deemed at intermediate or high surgical risk in a real-world setting with minimal exclusion criteria.
The UK TAVI trial was funded by the National Institute for Health Research Technology Assessment Programme with support from the institute’s Leicester Biomedical Research Centre.