Valvular & structural heart disease
Outcomes After Transcatheter Aortic Valve Implantation in Patients Excluded From Clinical Trials
Main finding · Net adverse clinical eventsResult — go to the resultAdjusted odds ratio 1.83 95% CI 1.73–1.95Authors' conclusion
Patients undergoing CTE-TAVI have a higher likelihood of mortality, stroke, and bleeding than those undergoing CTI-TAVI.
Study context
- Population
- Patients undergoing Transcatheter Aortic Valve Implantation (TAVI), US National Readmission Database, 2015–2019
- Participants
- 223,238 patients
- Exposure
- TAVI in clinical-trial-excluded vs clinical-trial-included patients
- CTE-TAVIn = 41,408
- Outcome
- Net adverse clinical events:
- Mortality
- Stroke
- Major bleeding
- Follow-up
- Index admission
Methodological detailspropensity-score matched
- Propensity-score matched
Main finding
Net adverse clinical events
Adjusted odds ratio
1.83
95% CI 1.73–1.95
CTE-TAVIvs CTI-TAVI
aOR 1.83 (95% CI 1.73–1.95)
As reported in the abstract
Observational data: associations, not effects.
Further findings
| Outcome | aOR (95% CI) | |
|---|---|---|
| Components: mortality, stroke, major bleeding · index admissionMortality | 2.94 (2.66–3.24) | |
| Components: mortality, stroke, major bleeding · index admissionStroke | 1.20 (1.07–1.34) | |
| Components: mortality, stroke, major bleeding · index admissionMajor bleeding | 1.49 (1.36–1.63) | |
| 0.20.5125Adjusted odds ratio (log scale) |
- CTE-TAVI utilization trend · 2015-2019
- 18.5% · 41,408
- CTE-TAVI utilization trend — Steep yearly increase in CTE-TAVI utilization
- P = 0.026
Outcomes by individual contraindication (subgroups) · 30 and 180 days
- Bicuspid aortic valve, leukopenia, peptic ulcer disease: similar outcomes vs clinical trials included TAVI (CTI-TAVI)
- End-stage renal disease, bioprosthetic aortic valves, coagulopathy: higher readmission rate at 30 and 180 days
Original publication
Outcomes After Transcatheter Aortic Valve Implantation in Patients Excluded From Clinical Trials. JACC Adv. Published 31 March 2023. doi:10. 1016/ j. jacadv. 2023. 100271
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