SAN FRANCISCO – Patients at low risk for surgical mortality who underwent transcatheter aortic valve replacement (TAVR) with the balloon-expandable Sapien 3 valve demonstrated meaningful quality-of-life benefits compared with those who underwent surgical aortic valve replacement (SAVR), according to a substudy of the PARTNER 3 trial presented Sunday at Transcatheter Cardiovascular Therapeutics 2019.
In presenting the results, Suzanne J. Baron, MD, MSc, of Saint Luke’s Mid-America Heart Institute, Kansas City, Missouri, noted that both PARTNER 3 and the Evolut low-risk trial, which compared low-risk patients who underwent TAVR with a self-expanding CoreValve, Evolut R or Evolut Pro valve (Medtronic), showed that transfemoral TAVR is safe and effective in these patients.
Baron and colleagues conducted the quality-of-life prospective study alongside the PARTNER 3 trial to evaluate the health status of low-risk patients receiving the Sapien 3 valve. The primary endpoint was change in Kansas City Cardiomyopathy Questionnaire (KCCQ) score over time, according to a manuscript simultaneously published in the Journal of the American College of Cardiology.
At 1 month, TAVR was associated with health status than SAVR (mean difference in KCCQ score 16.0 points; p<0.001). At 6 and 12 months, health status remained better with TAVR, although the effect was reduced (mean difference in KCCQ score 2.6 points at 6 months and 1.8 points at 12 months; p<0.04 for both). The proportion of patients with excellent outcomes (alive with KCCQ ≥ 75 and no significant decline from baseline) was greater with TAVR than with SAVR at 6 months (TAVR 90.3% vs. SAVR 85.3%; p=0.03) and at 12 months, although the difference at this timepoint was not significant (TAVR 87.3% vs. 82.8%; p=0.07), Baron and colleagues reported.
“Taken together with the clinical outcomes of the PARTNER 3 trial, these findings further support the use of TAVR in patients with severe aortic stenosis at low surgical risk,” Baron said during a press conference announcing the results.
She added that longer-term follow-up is needed to determine whether the health-status benefit of TAVR lasts beyond 1 year in low-risk patients.
The PARTNER 3 trial and quality-of-life substudy were funded by Edwards Lifesciences.