Key result
Five new-generation TAVI devices show similar rates of major adverse events at 12 months.
Why the study?
There is uncertainty regarding the comparative effectiveness and safety of contemporary transcatheter aortic valve implantation devices.
Do different new-generation TAVI devices have comparable safety and effectiveness at 12 months in patients with severe aortic stenosis?
Population
1976 patients undergoing TAVI in an ongoing national Italian registry
Comparison
Acurate Neo vs Evolut Pro/R vs Lotus vs Portico vs Sapien/Sapien S3 Ultra
Design
National registry-based observational study
Follow-up
12 months
Authors
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Comparable 12-month TAVI outcomes support flexible device selection; leaves open device-specific complication trade-offs in prospective trials.
Observational (n=1,976)
Yes
Do different new-generation TAVI devices have comparable safety and effectiveness at 12 months in patients with severe aortic stenosis?
p-value: p=0.21
Five leading new-generation TAVI devices demonstrate comparable 12-month rates of major adverse events, though they differ in specific complication profiles such as vascular complications and pacemaker requirements.
Corcione et al. (2021) conducted an observational in Severe aortic stenosis (n=1,976). New-generation TAVI devices (Acurate, Evolut, Lotus, Portico, Sapien) vs. Compared against each other was evaluated on Major adverse events (composite of death, stroke, MI, major bleeding, major vascular complication, SAVR, and TAVI reimplantation) (p=0.21). At 12 months, five leading new-generation TAVI devices demonstrated similarly favorable results with no significant difference in major adverse events (P=0.21) or death (P=0.29).
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