Home > Uncategorized > EVAR-1 15 year Follow Up

EVAR-1 15 year Follow Up

Patel et al report the 15 year outcomes of the EVAR trial. The EVAR show an early survival effect but was inferior to open repair in the long term. Device related complications e.g. secondary aneurysm sac rupture was the dominant device relate d late mortality.

Abstract

Background

Short-term survival benefi ts of endovascular aneurysm repair (EVAR) versus open repair of intact
abdominal aortic aneurysms have been shown in randomised trials, but this early survival benefi t is lost after a few
years. We investigated whether EVAR had a long-term survival benefi t compared with open repair.

Methods

We used data from the EVAR randomised controlled trial (EVAR trial 1), which enrolled 1252 patients from
37 centres in the UK between Sept 1, 1999, and Aug 31, 2004. Patients had to be aged 60 years or older, have aneurysms
of at least 5·5 cm in diameter, and deemed suitable and fi t for either EVAR or open repair. Eligible patients were
randomly assigned (1:1) using computer-generated sequences of randomly permuted blocks stratifi ed by centre to
receive either EVAR (n=626) or open repair (n=626). Patients and treating clinicians were aware of group assignments,
no masking was used. The primary analysis compared total and aneurysm-related deaths in groups until mid-2015 in
the intention-to-treat population. This trial is registered at ISRCTN (ISRCTN55703451).

Findings

We recruited 1252 patients between Sept 1, 1999, and Aug 31, 2004. 25 patients (four for mortality outcome)
were lost to follow-up by June 30, 2015. Over a mean of 12·7 years (SD 1·5; maximum 15·8 years) of follow-up, we
recorded 9·3 deaths per 100 person-years in the EVAR group and 8·9 deaths per 100 person-years in the open-repair
group (adjusted hazard ratio [HR] 1·11, 95% CI 0·97–1·27, p=0·14). At 0–6 months after randomisation, patients in
the EVAR group had a lower mortality (adjusted HR 0·61, 95% CI 0·37–1·02 for total mortality; and 0·47, 0·23–0·93
for aneurysm-related mortality, p=0·031), but beyond 8 years of follow-up open-repair had a signifi cantly lower
mortality (adjusted HR 1·25, 95% CI 1·00–1·56, p=0·048 for total mortality; and 5·82, 1·64–20·65, p=0·0064 for
aneurysm-related mortality). The increased aneurysm-related mortality in the EVAR group after 8 years was mainly
attributable to secondary aneurysm sac rupture (13 deaths [7%] in EVAR vs two [1%] in open repair), with increased
cancer mortality also observed in the EVAR group.

Interpretation

EVAR has an early survival benefi t but an inferior late survival compared with open repair, which needs
to be addressed by lifelong surveillance of EVAR and re-intervention if necessary.
Funding UK National Institute for Health Research, Camelia Botnar Arterial Research Foundation

evar01
evar02
evar03

Advertisements
Categories: Uncategorized
  1. No comments yet.
  1. No trackbacks yet.

Leave a Reply

Fill in your details below or click an icon to log in:

WordPress.com Logo

You are commenting using your WordPress.com account. Log Out / Change )

Twitter picture

You are commenting using your Twitter account. Log Out / Change )

Facebook photo

You are commenting using your Facebook account. Log Out / Change )

Google+ photo

You are commenting using your Google+ account. Log Out / Change )

Connecting to %s

%d bloggers like this: