Cohort study
Comparison of Unibody and Non-Unibody Endografts for Abdominal Aortic Aneurysm Repair in Medicare Beneficiaries: The SAFE-AAA Study
- Retrospective cohort study
- prespecified
- noninferiority
- inverse probability weighting
Authors' 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 beneficiaries · 2,146 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
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
Unibody vs 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, 2017 · prespecified 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:10.1161/circulationaha.122.062123
Summarised from the published abstract; every number is checked against it