September 28, 2019
PARTNER 3 Quality-of-Life Substudy Shows Sustained Health Status for TAVR at 1 Year
September 29, 2019—The Cardiovascular Research Foundation (CRF) announced that results from the PARTNER 3 Quality-of-Life Substudy were presented by Suzanne J. Baron, MD, at TCT 2019, the 31st annual Transcatheter Cardiovascular Therapeutics scientific symposium, which is sponsored by CRF and held September 25–29 in San Francisco, California. Dr. Baron et al published the findings online in Journal of the American College of Cardiology.
As summarized by CRF, the new analysis of the PARTNER 3 data found a modest, but significant, improvement in 1-year disease-specific quality of life after transcatheter aortic valve replacement (TAVR) compared with surgical aortic valve replacement (SAVR) in low-risk patients with severe aortic stenosis (AS).
Previously, the randomized PARTNER 3 trial demonstrated that TAVR with the Sapien 3 valve (Edwards Lifesciences) resulted in lower rates of death and rehospitalization at 1 year compared with SAVR in patients with severe AS at low surgical risk.
The analysis compared health status at 1, 6, and 12 months in low-risk patients with severe AS treated with either TAVR or SAVR in the PARTNER 3 trial.
The analysis found that over the 1-year follow-up period, treatment with either TAVR or SAVR resulted in substantial improvements in both disease-specific and generic health status compared with baseline, despite most patients having only New York Heart Association class I or II symptoms at baseline.
Additionally, consistent with previous studies of transfemoral TAVR, the therapy was associated with significantly better health status than SAVR at 1 month on all scales (mean difference in Kansas City Cardiomyopathy Questionnaire—Overall Summary [KCCQ–OS] 16.0 points; P < .001). However, in contrast to previous studies, the investigators observed a persistent, although attenuated, benefit of TAVR over SAVR in disease-specific health status at 6 and 12 months (mean difference in KCCQ-OS 2.6 and 1.8 points respectively; P < .04 for both).
In analyses that incorporated both survival and change in health status together, TAVR also demonstrated a significant health status benefit compared with SAVR at all time points (P < .05). Exploratory analyses demonstrated that the late health status benefits seen with TAVR were driven by a difference in the proportion of patients who experienced a large (ie, ≥ 20 point) improvement in the KCCQ score. These benefits may be explained, in part, by differential rates of postprocedural complications between TAVR and SAVR, reported CRF.
Dr. Baron commented in the CRF announcement, “This is the first randomized trial to demonstrate a persistent, albeit modest, disease-specific health status advantage with TAVR at 6 and 12 months—time points at which patients are assumed to have recovered fully from surgery. Further studies are needed to evaluate the durability of health status benefits with TAVR compared with SAVR beyond 1 year in this low-risk population.”