Comprehensive Analysis of Mortality Among Patients Undergoing TAVR
Key result
Transfemoral TAVR cuts mortality ~67% versus standard therapy in inoperable severe aortic stenosis.
- n=1,057
Why the study?
The study sought to compare the timing and modes of death after TAVR versus surgical AVR or standard therapy in high-risk or inoperable severe aortic stenosis.
Does TAVR alter the timing and causes of death compared to surgical AVR or standard therapy in patients with severe aortic stenosis who are high risk or inoperable?
Population
Severe aortic stenosis patients deemed too high risk or inoperable for conventional AVR in the PARTNER trial
Comparison
TAVR (TF or TA) vs AVR (PARTNER-A) or standard therapy (PARTNER-B)
Design
Randomized controlled trial analysis
Follow-up
2.5 years
Authors
Discussion
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Implication
Should not yet change access or SAVR decisions in high-risk AS; leaves open the clinical weight of early versus late mortality patterns.
Key Points
- To compare the timing and causes of death following transcatheter aortic valve replacement (TAVR) versus surgical aortic valve replacement (AVR) or standard medical therapy.
- Randomized clinical trial (PARTNER; NCT00530894) assessing high-risk patients (PARTNER-A: 244 transfemoral TAVR, 104 transapical TAVR, 351 surgical AVR) and inoperable patients (PARTNER-B: 179 transfemoral TAVR, 179 standard therapy).
- Categorized deaths as cardiovascular, noncardiovascular, or uncategorizable and characterized mortality trajectories using multiphase hazard modelling over up to 2.5 years.
- In high-risk patients (PARTNER-A), peri-procedural risk peaked early with TA-TAVR and AVR before stabilizing by 3 months, whereas TF-TAVR had lower initial risk but similar 2-year survival; CV deaths occurred in 37% of TF-TAVR, 22% of TA-TAVR, and 33% of AVR cases.
- In inoperable patients (PARTNER-B), TF-TAVR reduced annual mortality risk from 60% per year with standard therapy to 20% per year, conferring an additional 0.5 years of life within 2.5 years.
Study Design
Type
RCT (n=1,057)
Randomization
randomized
Structured PICO
Does TAVR alter the timing and causes of death compared to surgical AVR or standard therapy in patients with severe aortic stenosis who are high risk or inoperable?
P
Population
1,057 patients with severe aortic stenosis deemed too high risk or inoperable for conventional AVR, randomized to TAVR, surgical AVR, or standard therapy and followed for up to 2.5 years.
I
Intervention
Transcatheter aortic valve replacement (TAVR) via transfemoral (TF) or transapical (TA) approach
C
Comparator
Surgical aortic valve replacement (AVR) for high-risk patients (PARTNER-A arm) or standard therapy for inoperable patients (PARTNER-B arm)
O
Outcome
Timing and causes of death (categorized as cardiovascular, noncardiovascular, or uncategorizable)hard clinical
Main Result
Absolute Event Rate: 20% vs 60%
TF-TAVR substantially reduces mortality in inoperable patients with severe aortic stenosis and offers lower early mortality risk compared to surgical AVR in high-risk patients.
Cite This Study
Svensson et al. (2014) conducted an RCT in Severe aortic stenosis (n=1,057). Transcatheter aortic valve replacement (TAVR) vs. Surgical AVR or standard therapy was evaluated on Mortality risk per year (PARTNER-B arm). In inoperable patients with severe aortic stenosis, transfemoral TAVR reduced mortality risk to 20% per year compared to 60% per year with standard therapy, adding 0.5 years of life within 2.5 years.