Valvular & structural heart disease
Valve Underexpansion and Clinical Outcomes With ACURATE neo2: Findings From the ACURATE IDE Trial
Primary result · Death, stroke, or rehospitalizationResult — go to the resultHazard ratio 1.92 95% CI 1.27–2.91Authors' conclusion
Underexpansion of the ACURATE neo2 valve in the ACURATE IDE study was associated with a higher risk of the composite endpoint of death, stroke, or rehospitalization.
Study context
- Population
- Patients implanted with ACURATE neo2 in the ACURATE IDE trial's main randomised cohort with evaluable procedural angiogramsmain randomised cohort n = 752
- Participants
- 624 patients
- Comparison
- Underexpanded vs expanded ACURATE neo2 valves
- Underexpandedn = 135
- Primary endpoint
- Death, stroke, or rehospitalization
- Follow-up
- 1 year
Methodological detailsexploratory analysis, independent core laboratory
- Exploratory analysis
- Independent core laboratory
Primary result
As reported in the abstract
Hazard ratio
1.92
95% CI 1.27–2.91
P = 0.002
By group
Underexpandedvs Expanded
HR 1.92 (95% CI 1.27–2.91); P = 0.002
Further findings
Predictor of underexpansion: greater baseline leaflet and annulus calcification
| OR (95% CI) | P value | ||
|---|---|---|---|
| Greater calcificationIndependently associated | 1.92 (1.27–2.91) | P = 0.002 | |
| 0.20.5125Odds ratio (log scale) |
Postdilation
P = 0.72
| Outcome | Underexpanded | Expanded |
|---|---|---|
| Prevalence of underexpansion | 21.6% | — not stated in the abstract |
— not stated in the abstract
Postdilation
- Predilation 100% in both groups; balloon sizing did not differ
Original publication
Valve Underexpansion and Clinical Outcomes With ACURATE neo2: Findings From the ACURATE IDE Trial. J Am Coll Cardiol. Published 21 May 2025. doi:10.
Composed by AI from the published abstract and checked against it. How Briefs are made →