July 1, 2012EuroIntervention
A prospective, randomised trial of transapical transcatheter aortic valve implantation vs. surgical aortic valve replacement in operable elderly patients with aortic stenosis: the STACCATO trial
Why the study?
Does transapical transcatheter aortic valve implantation reduce the composite of all-cause mortality, cerebral stroke and/or renal failure requiring haemodialysis at 30 days compared to surgical aortic valve replacement in operable elderly patients with isolated aortic valve stenosis?
Population
70 operable patients with isolated aortic valve stenosis and an age ≥75 years
Comparison
Transapical transcatheter aortic valve… vs Surgical aortic valve replacement (SAVR)
Design
RCT, randomised
Follow-up
30 days
Authors
Discussion
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Member takes
Implication
Signals excess 30-day events with early transapical TAVI versus SAVR; challenges its use in operable elderly patients and reinforces SAVR preference.
Structured PICO
Does transapical transcatheter aortic valve implantation reduce the composite of all-cause mortality, cerebral stroke and/or renal failure requiring haemodialysis at 30 days compared to surgical aortic valve replacement in operable elderly patients with isolated aortic valve stenosis?
P
Population
70 operable patients with isolated aortic valve stenosis and an age ≥75 years
I
Intervention
Transapical transcatheter aortic valve implantation (a-TAVI)
C
Comparator
Surgical aortic valve replacement (SAVR)
O
Outcome
Composite of all-cause mortality, cerebral stroke and/or renal failure requiring haemodialysis at 30 dayscomposite
In operable elderly patients with aortic stenosis, early-generation transapical TAVI was associated with an excess of adverse events compared to SAVR, leading to premature trial termination.
Limitations
- small prematurely terminated study
Cite This Study
Nielsen et al. (2012) studied this question.