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TAVR versus surgery in older patients

Presented by
Dr W. Toff, University of Leicester, UK
ACC 2020
In a new, real-world study evaluating patients aged 70 years or older, transcatheter aortic valve replacement (TAVR) was not inferior to surgery with respect to death from any cause at 1 year.

Dr William Toff (University of Leicester, UK) presented 1-year follow-up data from UK TAVI study, which involved participants treated at 34 UK sites who were ≥70 years (with additional risk factors) or ≥80 years (with or without additional risk factors) [1]. The mean age was 81 years. The unmet need this trial attempted to address was that although previous clinical trials have found TAVR to be non-inferior or superior to open-heart surgery, most trials have been limited to a younger cohort and mostly only evaluated outcomes from high-volume TAVR centres.

The UK TAVI trial enrolled 913 patients who had been referred for treatment of severe aortic stenosis between 2014 to 2018 at any UK centre that performed TAVR, regardless of volume. Participants were randomly assigned to receive TAVR or open-heart surgery and will be followed up for at least 5 years.

At 1 year, the prespecified threshold for non-inferiority of TAVR was met. The primary endpoint, the rate of death from any cause, was 4.6% in the TAVR group and 6.6% in the surgery group (HR 0.69; 95% CI 0.38-1.26; P=0.23). This treatment effect was similar in subgroup analyses, accounting for coronary artery disease requiring revascularisation, age, gender, Society of Thoracic Surgeons (STS) score, and frailty. Rates of death from cardiovascular disease or stroke were also similar between the 2 groups.

Major bleeding events in the TAVR group were lower compared with surgery (6.3% vs 17.1%; P< 0.001). TAVR was also associated with a shorter hospital stay, fewer days in intensive care, and a faster improvement in functional capacity and quality of life. At 6 weeks after the procedure, functional capacity and quality-of-life measures were better in the TAVR group, but by 1 year they were similar in the 2 groups. However, patients in the TAVR arm did have a significantly higher rate of vascular complications (4.8%) than those receiving surgery (1.3%). TAVR patients were also more likely to have a pacemaker implanted compared with those undergoing surgery (12.2% vs 6.6%). Furthermore, mild aortic regurgitation occurred at 1 year in 38.3% of the TAVR group and 11.7% of the surgery group, whereas moderate regurgitation occurred in 2.3% of TAVR patients and 0.6% of surgery patients.

In conclusion, both TAVR and surgery were safe in older patients, although each procedure had its particular benefits and risks. Prof. Toff said the findings support those of earlier TAVR trials while being “more reflective of the real world.”

    1. Toff WD, et al. Abstract 405-14. ACC/WCC 28-30 March 2020.

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