Valvular & structural heart disease
One-year clinical outcomes of transcatheter aortic valve implantation with the latest iteration of self-expanding or balloonexpandable devices: insights from the OPERA-TAVI registry
Authors' conclusion
One-year clinical outcomes of patients undergoing transfemoral TAVI and receiving PRO or ULTRA devices in the current clinical practice were similar, but PRO patients had higher rates of disabling stroke.
Study context
- Population
- Transcatheter aortic valve implantation (TAVI) patients with complete 1-year follow-up in the OPERA-TAVI registry
- Participants
- 1,897 patients587 matched pairs
- Exposure
- Evolut PRO/PRO (PRO)/PRO+ vs SAPIEN 3 Ultra for TAVI
- Outcome
- Composite of:
- All-cause death
- Disabling stroke
- Rehospitalisation for HF
- Follow-up
- 1 year
Methodological details1:1 matching, prespecified subgroups
- 1:1 matching
- Prespecified subgroups
Main finding
As reported in the abstract
P = 0.27
Observational data: associations, not effects.
Further findings
Primary outcome across 5 prespecified anatomical subgroups
- Consistent across all prespecified anatomical subsets
- all pinteraction>0.10
Safety
Disabling stroke · 30 days
P = 0.004
KM estimate
| Outcome | PRO | ULTRA | P value |
|---|---|---|---|
| Disabling stroke · 1 yearLog-rank | 2.6% | 0.4% | P = 0.001 |
Original publication
One-year clinical outcomes of transcatheter aortic valve implantation with the latest iteration of self-expanding or balloonexpandable devices: insights from the OPERA-TAVI registry. EuroIntervention. Published 1 January 2024. doi:10.
Composed by AI from the published abstract and checked against it. How Briefs are made →