United Kingdom Endovascular Aneurysm Repair 2 - EVAR 2
The goal of the trial was to evaluate treatment of abdominal aortic aneurysms by endovascular repair compared with conservative therapy among patients ineligible for open surgery.
Endovascular repair of abdominal aortic aneurysm would be associated with lower operative and long-term mortality.
Patients Enrolled: 404
Mean Follow Up: Median of 3.1 years
Mean Patient Age: 77 years
- Patients at least 60 years of age and suitable for either endovascular or open repair
- Abdominal aortic aneurysm at least 5.5 cm in diameter
- All-cause mortality
- Aneurysm-related mortality
- Graft-related complication
- Graft-related reintervention
Patients with an abdominal aortic aneurysm were randomized to endovascular repair (n = 197) versus medical management (n = 207).
Overall, 404 patients were enrolled. There was no difference in baseline characteristics between the groups. In the endovascular repair group, the mean age was 77 years, 85% were men, mean diameter of abdominal aortic aneurysm was 6.8 cm, body mass index was 26 kg/m2, 6.1% of patients never smoked, mean systolic blood pressure was 140 mm Hg, use of aspirin was 58%, and statin was 42%.
The 30-day operative mortality was 7.3% in the endovascular repair group. The all-cause death rate was 21.0/100 person-years in the endovascular group versus 22.1/100 person-years in the no repair group (p = 0.97). There was no benefit in this outcome within 6 months (adjusted hazard ratio [HR] 1.32, p = 0.41), between 6 months and 4 years (adjusted HR 1.02, p = 0.92), or after 4 years (adjusted HR = 0.72, p = 0.24).
The aneurysm-related death rate was 3.6/100 person-years in the endovascular group versus 7.3/100 person-years in the no repair group (p = 0.02). There was no benefit in this outcome within 6 months (adjusted HR 1.78, p = 0.19), although benefit was observed between 6 months and 4 years (adjusted HR 0.34, p = 0.005).
After endovascular repair, graft-related complications occurred in 48% and reinterventions were required in 27%. The rupture rate in the no repair group was 12.4/100 person-years.
Among patients with abdominal aortic aneurysm, ineligible for open surgery repair, endovascular repair is associated with relatively high operative mortality, graft-related complications, and reinterventions. Although aneurysm-related deaths between 6 months and 4 years were reduced from endovascular repair compared with medical management, there was no reduction in all-cause mortality.
An explanation why all-cause mortality was not reduced from endovascular repair was the limited life expectancy among these patients as few survived beyond 8 years. Since endovascular repair was associated with relatively high operative mortality, high frequency of late complications and reintervention, and no benefit in all-cause mortality from endovascular repair, the application of this strategy needs to be individualized to high-risk patients.
The United Kingdom EVAR Trial Investigators. Endovascular repair of aortic aneurysm in patients physically ineligible for open repair. N Engl J Med 2010;Apr 11:[Epub ahead of print].
Keywords: Cause of Death, Endovascular Procedures, Body Mass Index, Smoke, Life Expectancy, Blood Pressure, Aortic Aneurysm, Abdominal, Systole, Peripheral Vascular Diseases, Vascular Surgical Procedures
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