Five-Year Outcomes of Transfemoral Transcatheter Aortic Valve Replacement or Surgical Aortic Valve Replacement in a Real World Population
Key result
Transfemoral TAVR was associated with higher 5-year mortality than SAVR in propensity-matched patients with severe aortic stenosis at low and intermediate risk (48.3% vs 35.8%; HR 1.38; P=0.002).
Why the study?
Although 1-year mortality was similar after transfemoral TAVR and SAVR in real-world propensity-matched patients at low and intermediate risk, 5-year outcomes remained to be evaluated.
Does transfemoral TAVR compared to SAVR improve 5-year mortality and major adverse cardiac and cerebrovascular events in real-world patients with severe aortic stenosis at low and intermediate risk?
Population
1300 propensity-matched patients with aortic stenosis at low and intermediate risk (7618 enrolled)
Comparison
Transfemoral TAVR vs SAVR
Design
Observational propensity-matched cohort study
Follow-up
5 years
Authors
Discussion
Loading...
Member takes
Implication
Caution advised with transfemoral TAVR in low- and intermediate-risk patients; leaves open need for randomized long-term confirmation.
Study Design
Type
Observational (n=1,300)
Structured PICO
Does transfemoral TAVR compared to SAVR improve 5-year mortality and major adverse cardiac and cerebrovascular events in real-world patients with severe aortic stenosis at low and intermediate risk?
P
Population
1,300 propensity-matched patients with severe aortic stenosis at low and intermediate risk, followed for 5 years.
E
Exposure
Transfemoral transcatheter aortic valve replacement (TAVR) using first-generation devices
C
Comparator
Surgical aortic valve replacement (SAVR)
O
Outcome
Death from any cause and major adverse cardiac and cerebrovascular events at 5 yearscomposite
Main Result
Hazard Ratio: 1.38 (95% CI 1.12–1.69)
Absolute Event Rate: 48.3% vs 35.8%
p-value: p=0.002
In a real-world, propensity-matched cohort of low- and intermediate-risk patients with severe aortic stenosis, SAVR was associated with lower 5-year mortality and MACCE compared to first-generation transfemoral TAVR.
Limitations
- Performed using first-generation devices
- Observational design requiring confirmation in randomized trials
- Use of first-generation TAVR devices
- Observational design requiring propensity matching
Cite This Study
Barbanti et al. (2019) conducted an observational in severe aortic stenosis (n=1,300). Transfemoral transcatheter aortic valve replacement (TAVR) vs. Surgical aortic valve replacement (SAVR) was evaluated on death from any cause (HR 1.38, 95% CI 1.12-1.69, p=0.002). Transfemoral TAVR was associated with higher 5-year mortality than SAVR in propensity-matched patients with severe aortic stenosis at low and intermediate risk (48.3% vs 35.8%; HR 1.38; P=0.002).