EVAR 2

Clinical Question

To evaluate the use of EVAR in AAA patients physically not suitable for open repair.

Bottom Line

In patients with AAAs who were considered physically ineligible for open repair, endovascular repair, as compared with no intervention, was associated with a significantly lower rate of aneurysm-related mortality in the long term, but with no reduction in total mortality. Endovascular repair was considerably more expensive than no intervention.

Major Points

EVAR was originally developed for patients who were considered to be physically ineligible for open surgical repair. Data was lacking on the question of whether endovascular repair reduces the rate of death among these patients, thus the EVAR 2 trial. While the study did find a reduction in aneurysm related death, there was no significant reduction in total mortality.

Guidelines

No guidelines.

Design

o Randomized trial across 33 U.K. hospitals from 1999 - 2004 o Randomly assigned pts to EVAR vs no intervention groups o 338 pts included in initial cohort up to mid-term results,  Later recruited additional 66 pts o 197 randomly assigned to EVAR o 207 assigned to no-intervention group o Primary outcome: Death from any cause,  Sub analyzed aneurysm-related death, graft-related complications and graft-related reinterventions.

Population

Inclusion Criteria Included 60+ y.o. patients with >5.5cm AAA (M&F), not qualifying for an open repair (mainly secondary to comorbidities, usually cardiac).

Baseline Characteristics

o Mean (±SD) age was 76.8±6.5 years, and 347 of the patients (86%) were men o The mean aneurysm diameter was 6.7±1.0 cm. o Pts followed between 5-10 yrs (or until death), median follow-up 3.1years o <1% loss to follow-up

Interventions

• 179 pts in the EVAR group underwent repair. • 70 pts in no-intervention group crossed over and had repair (became symptomatic or grew quickly). Outcomes

Primary Outcome

o Overall total mortality

 21.0 deaths per 100 person-years in EVAR group  22.1 deaths per 100 person-years in the no-intervention group  Adjusted hazard ratio with endovascular repair, 0.99; 95% CI, 0.78 to 1.27; P=0.97

o 7.3% 30-day operative mortality in EVAR group o 3% 30-day operative mortality in no-intervention group that crossed over and had repair

Secondary Outcomes

o Overall aneurysm-related mortality

 3.6 deaths per 100 person-years in the EVAR group  7.3 deaths per 100 person-years in the no-intervention group  Adjusted hazard ratio, 0.53; 95% CI, 0.32 to 0.89; P=0.02

o 68 ruptures, 63 of which were fatal, occurred in both study groups o 55 ruptures occurred in the no-intervention group, unadjusted rupture rate of 12.4 ruptures per 100 person-years. (95% CI, 9.6 to 16.2)

o 158 graft complications were reported in 97 patients

o Mean cost of the primary aneurysm repair was £13,301 (U.S. $20,124) in the EVAR group

o Mean cost of aneurysm-related readmissions was £1,694 ($2,563) in the EVAR group and £702 ($1,062) in the no-intervention group.

Subgroup Analysis

• A post hoc analysis comparing baseline fitness in the patients who crossed over to endovascular repair with patients assigned to endovascular repair who underwent repair showed that the patients who crossed over were significantly more fit. • The rate of aneurysm rupture appears to be lower among patients with a long aneurysm neck. • The use of statins may have further attenuated the rate of aneurysm rupture.

Adverse Events

Among the 179 patients in the endovascular-repair group who underwent aneurysm repair, 13 patients (7.3%) died within 30 days after the procedure. Criticisms A substantial minority of patients in the no-intervention group and their physicians opted in favor of repair, resulting in a loss of equipoise.

Funding

The trial was sponsored by the Health Technology Assessment Programme of the National Institute for Health Research in the United Kingdom.

EVAR 2

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