United Kingdom Endovascular Aneurysm Repair 2 - EVAR 2

Apr 12, 2010
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Author/Summarized by Author:
Anthony A. Bavry, MD, MPH, FACC
Summary Reviewer:
Deepak L. Bhatt, MD, MPH, MBA, FACC
Trial Sponsor:
Health Technology Assessment Programme of the National Institute for Health Research in the United Kingdom
Date Published:
01/01/2010
Date Updated:
04/12/2010
Original Posted Date:
04/12/2010
References

Description:

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.

Hypothesis:

Endovascular repair of abdominal aortic aneurysm would be associated with lower operative and long-term mortality.

Study Design

  • Parallel

Patients Enrolled: 404
Mean Follow Up: Median of 3.1 years
Mean Patient Age: 77 years
Female: 15%

Patient Populations:

  • 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

Primary Endpoints:

  • All-cause mortality

Secondary Endpoints:

  • Aneurysm-related mortality
  • Graft-related complication
  • Graft-related reintervention

Drug/Procedures Used:

Patients with an abdominal aortic aneurysm were randomized to endovascular repair (n = 197) versus medical management (n = 207).

Principal Findings:

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.

Interpretation:

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.

References:

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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