Aortic & peripheral vascular disease
Comparison of Unibody and Non-Unibody Endografts for Abdominal Aortic Aneurysm Repair in Medicare Beneficiaries: The SAFE-AAA Study
Main findingResult — go to the resultHazard ratio 1.19 95% CI 1.15–1.22Authors' conclusion
In the SAFE-AAA Study, unibody aortic stent grafts failed to meet noninferiority compared with non-unibody aortic stent grafts with respect to aortic reintervention, rupture, and mortality.
Study context
- Population
- Medicare beneficiaries undergoing aortic stent grafting for AAA at US hospitals, procedures August 1, 2011–December 31, 2017
- Participants
- 87,163 beneficiaries2,146 US hospitals
- Exposure
- Unibody vs non-unibody aortic stent grafts
- Unibodyn = 11,903
- Outcome
- Composite of:
- Aortic reintervention
- Rupture
- Mortality
- Follow-up
- Through December 31, 2019
Methodological detailsprespecified, noninferiority, inverse probability weighting
- Prespecified
- Noninferiority
- Inverse probability weighting
Main finding
As reported in the abstract
median follow-up, 3.4 years
Hazard ratio
1.19
95% CI 1.15–1.22
noninferior P value of 1.00
By group
Unibodyvs Non-unibody
HR 1.19 (95% CI 1.15–1.22); noninferior P value of 1.00
Observational data: associations, not effects.
Further findings
| Outcome | Unibody | Non-unibody | HR (95% CI) | |
|---|---|---|---|---|
| Primary end point, contemporary unibody grafts (AFX2) subgroup, February 22, 2016–December 31, 2017Prespecified subgroup · cumulative incidence | 37.5% | 32.7% | 1.06 (0.98–1.14) | |
| 0.512Hazard ratio (log scale) |
Falsification end points (HF, stroke, pneumonia)
- Negligibly different between groups
Original publication
Comparison of Unibody and Non-Unibody Endografts for Abdominal Aortic Aneurysm Repair in Medicare Beneficiaries: The SAFE-AAA Study. Circulation. Published 3 March 2023. doi:10.
Composed by AI from the published abstract and checked against it. How Briefs are made →