Authors' objectives:

The objective of the report was to assess the available evidence on the usefulness of elective endovascular repair for abdominal aortic aneurysm.

Authors' results and conclusions: A meta-analysis and two systematic reviews report a 2-5% mortality rate at 30 days, with a 5.9-13.1% risk of endoleak at 30 days and 5.4-10% during the following year. The rate of conversion to open surgery was about 5% at 30 days. AAA of at least 5 cm dia that are eligible for conventional surgery A RCT of 2004 which enrolled 345 patients with AAA less than 5 cm dia, with a 30-day follow-up, reported a 4.6% mortality rate for the surgery group and 1.4% for the endovascular repair group (RR 3.9 CI 95% 0.9 to 32.9). The combined endpoint of mortality plus severe complications was 9.8% for the surgery group and 4.7 for the endovascular group (RR 2.1 CI 95% 0.9 to 5.4). The EVAR trial (2004) enrolled 1,082 patients over 60 years of age with AAA of at least 5.5 cm dia. Mortality at 30 days was lower for the endovascular group (1.7% versus 4.7%; p=0.009). The need of a second intervention was higher in the endovascular repair group (9.8% versus 5.8%; p=0.02). During 4 year follow-up (2005), the mortality rate was 28% for both groups (p=0.46). The number of patients who presented complications during the 4-year follow-up was 41% in the endovascular group and 9% in the surgical group (p<0.0001). Another trial published in 2005 enrolled 351 patients with AAA of at least 5 cm dia. Survival at two years was 89.6% for the surgery group and 89.7% for the endovascular group. There were no significant differences in aneurysm-related survival, or in moderate or severe complication-free survival. AAA of at least 5.5 cm dia were not candidates for conventional surgery because of their high surgical risk. The EVAR2 trial published in 2005 randomized 338 patients to endovascular repair versus no treatment. Mean age was 76 years old. Mortality at 30 days for the endovascular group was 9%. Overall mortality at 4 years was 64%, with no significant differences between both groups (p= 0.25). There were no differences in quality of life for both groups but the cost was higher for the endovascular group ( 13,632 versus 4,983) 4 to 5.5 cm dia AAA Although open surgery is not indicated for this type of patients, endovascular repair is proposed because it is a less invasive procedure that would prevent rupture. No RCTs were found comparing endovascular repair with a wait-and-see approach to these patients. A 315 cohort of AAA patients with these characteristics treated with endovascular repair was compared with published data of 527 patients for whom the wait-and-see approach was used. There were no significant differences in rupture rate. Total mortality was higher in the control group (8.6% versus 6.4% at one year; p=0.02) Clinical Practice Guidelines: There is consensus among the different scientific societies about choosing endovascular repair for those patients with adequate anatomy and with moderate to high risk of death (6 a 10%) during open surgery. All the mentioned consensus appeared before the EVAR2 trial was published.

Authors' recommendations: There is no evidence of good methodology quality to date to support the use of endovascular repair in AAA smaller than 5 cm diameter. The elective endovascular repair did not show an additional benefit in those patients with AAA at least 5 cm dia who are candidates for conventional surgery. Although perioperative mortality is lower, it is similar for both groups in the long run. Besides, patients with endovascular repair need a closer follow-up because of a greater number of complications, mainly due to endoleaks. For those patients with AAA at least 5.5 cm dia at high risk for open surgery, it is necessary to conduct new trials to determine whether it is more beneficial to endovascular repair, or not to perform any intervention, since this is the sub-group of patients that could benefit the most from this procedure.

Authors' methods: Overview

Project Status: Completed

URL for project: http://www.iecs.org.ar/

Year Published: 2007

English language abstract: An English language summary is available

Publication Type: Not Assigned

Country: Argentina

Organisation Name: Institute for Clinical Effectiveness and Health Policy

Contact Address: Dr. Emilio Ravignani 2024, Buenos Aires - Argentina, C1414 CABA

Contact Name: info@iecs.org.ar

Contact Email: info@iecs.org.ar

Copyright: Institute for Clinical Effectiveness and Health Policy (IECS)