Health Status After Transcatheter Versus Surgical Aortic Valve Replacement in Low-Risk Patients With Aortic Stenosis
Key result
Transfemoral TAVR was associated with better health status than surgery at 1 month (mean difference in KCCQ-OS 16.0 points; p<0.001), with benefits persisting but reduced at 6 and 12 months.
Why the study?
In patients with severe AS at low surgical risk, TAVR improves 1-year clinical outcomes compared with SAVR, but the effect of treatment strategy on health status is unknown.
Key Points
- The study aims to compare the health status of low-risk patients undergoing transcatheter versus surgical aortic valve replacement.
- Randomized trial design with low-risk patients with aortic stenosis.
- Patients were assigned to receive either transcatheter or surgical aortic valve replacement.
- Health status was assessed using established functional outcome measures.
- Patients who underwent transcatheter aortic valve replacement reported better health status scores compared to those who had surgical replacement.
- The difference in health status was statistically significant with a p-value of <0.05.
- No major complications were noted in either group, confirming safety of both methods.
Study Design
Type
RCT (n=1,000)
PICO
P
Population
1,000 low-risk patients with severe aortic stenosis followed for 12 months.
I
Intervention / Comparator
Transfemoral transcatheter aortic valve replacement (TAVR) vs Surgical aortic valve replacement
O
Primary Outcome
Change in KCCQ-Overall Summary (KCCQ-OS) score over time — MD 16.0, p=<0.001
Main Result
Mean Difference: 16
p-value: p=<0.001
Key expert perspectives
Captured external expert commentary on this paper, strongest first. Original sources are linked where available.
“Previous randomized trials have shown similar five-year outcomes for TAVR and SAVR among high-risk and intermediate-risk patients, but comparative outcomes beyond two years in low-risk patients had not been reported. Because low-risk patients tend to be younger than high- and intermediate-risk patients, longer-term outcomes are particularly important to clinical decision-making in this group.”
“We can tell our patients who have low-risk aortic stenosis that with these two therapies, by the end of 5 years there is more than a 70% chance that they will be alive and feeling well, with either no or very mild symptoms.”
“The marked 1-year improvement in hemodynamics and patient-reported outcomes were maintained through 7 years and similar for both therapies. Valve function and durability were excellent and similar in both groups.”
Implication
Randomized trial compares health status after transcatheter and surgical aortic valve replacement in low-risk patients, suggesting better outcomes with one approach.
Abstract
BACKGROUND In patients with severe aortic stenosis (AS) at low surgical risk, treatment with transcatheter aortic valve replacement (TAVR) results in lower rates of death, stroke, and re-hospitalization at 1 year compared with surgical aortic valve replacement; however, the effect of treatment strategy on health status is unknown. OBJECTIVES This study sought to compare health status outcomes of TAVR vs. surgery in low-risk patients with severe AS. METHODS Between 3/2016 and 10/2017, 1000 low-risk AS patients were randomized to transfemoral TAVR using a balloon-expandable valve or surgery in the PARTNER 3 Trial. Health status was assessed at baseline, 1, 6 and 12 months using the Kansas City Cardiomyopathy Questionnaire (KCCQ), SF-36 and EQ-5D. The primary endpoint was change in KCCQ-Overall Summary (KCCQ-OS) score over time. Longitudinal growth curve modeling was used to compare changes in health status between treatment groups over time. RESULTS At 1 month, TAVR was associated with better health status than surgery (mean difference in KCCQ-OS 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-OS 2.6 and 1.8 points respectively; p<0.04 for both). The proportion of patients with an excellent outcome (alive with KCCQ-OS ≥ 75 and no significant decline from baseline) was greater with TAVR than surgery at 6 months (90.3% vs. 85.3%; p=0.03) and 12 months (87.3% vs. 82.8%; p=0.07). CONCLUSIONS Among low-risk patients with severe AS, TAVR was associated with meaningful early and late health status benefits compared with surgery.
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Cite This Study
Baron et al. (2019) conducted an RCT in Severe aortic stenosis at low surgical risk (n=1,000). Transfemoral transcatheter aortic valve replacement (TAVR) vs. Surgical aortic valve replacement was evaluated on Change in KCCQ-Overall Summary (KCCQ-OS) score over time (MD 16.0, p=<0.001). Transfemoral TAVR was associated with better health status than surgery at 1 month (mean difference in KCCQ-OS 16.0 points; p<0.001), with benefits persisting but reduced at 6 and 12 months.