Endovascular aneurysm repair (EVAR) trials 1 and 2

Conditions

Cardiovascular diseases: peripheral arterial disease Circulatory System Peripheral arterial disease

Patel R, Powell JT, Sweeting MJ, Epstein DM, Barrett JK, Greenhalgh RM.

2018-01-0186 citations

10.3310/hta22050

Meta-analysis of individual-patient data from EVAR-1, DREAM, OVER and ACE trials comparing outcomes of endovascular or open repair for abdominal aortic aneurysm over 5 years.

Powell JT, Sweeting MJ, Ulug P, Blankensteijn JD, Lederle FA, Becquemin JP, Greenhalgh RM, EVAR-1, DREAM, OVER and ACE Trialists.

2017-02-01293 citations

10.1002/bjs.10430

Endovascular versus open repair of abdominal aortic aneurysm in 15-years' follow-up of the UK endovascular aneurysm repair trial 1 (EVAR trial 1): a randomised controlled trial.

Patel R, Sweeting MJ, Powell JT, Greenhalgh RM, EVAR trial investigators.

2016-10-12703 citations

10.1016/s0140-6736(16)31135-7

Endovascular versus open repair of abdominal aortic aneurysm.

United Kingdom EVAR Trial Investigators, Greenhalgh RM, Brown LC, Powell JT, Thompson SG, Epstein D, Sculpher MJ.

2010-04-11735 citations

10.1056/nejmoa0909305

Endovascular repair of aortic aneurysm in patients physically ineligible for open repair.

United Kingdom EVAR Trial Investigators, Greenhalgh RM, Brown LC, Powell JT, Thompson SG, Epstein D.

2010-04-11198 citations

10.1056/nejmoa0911056

Interventions

EVAR Trial 1: EVAR versus open repair in patients considered fit for open repair EVAR Trial 2: EVAR and medical management versus medical management alone in patients considered unfit for open repair

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: EVAR Trial 1: 1. Males or females 2. Aged at least 60 years 3. Abdominal Aortic Aneurysm (AAA) measuring at least 5.5 cm on a Computed Tomography (CT) scan 4. AAA deemed anatomically suitable for an EndoVascular Aneurysm Repair (EVAR) device 5. Patient considered anaesthetically fit for an open repair EVAR Trial 2: 1. Males or females 2. Aged at least 60 years 3. Abdominal Aortic Aneurysm (AAA) measuring at least 5.5 cm on a CT scan 4. AAA deemed anatomically suitable for an EndoVascular Aneurysm Repair (EVAR) device 5. Patient considered anaesthetically unfit for an open repair

Exclusion criteria

Exclusion criteria: EVAR Trial 1: 1. Does not match inclusion criteria 2. Not fit for open repair (added 27/05/2016) EVAR Trial 2: Patients with hostile abdomen anatomically unsuitable for open repair but anaesthetically well enough for the open operation were excluded.

Design outcomes

Primary

Measure	Time frame
All-cause and aneurysm-related mortality. Added 27/05/2016: Follow-up will be until the end of June 2015 Previous: Follow-up will be until the end of 2009	—

Secondary

Measure	Time frame
As of 27/05/2016: 1. Health Related Quality of Life (HRQL): 1.1. SF-36® Health Survey at 1 year 1.2. Euroqol EQ-5D, assessed annually until the end of 2009 2. Durability of AAA grafts and incidence of complications and re-interventions, followed-up until 2015 3. Costs and cost effectiveness. Data for costs will be collected until 2015 4. Renal function assessed annually until the end of 2009 Please note that methods of assessment for HRQL and the timepoints of assessment for all secondary outcome measures were added as of 06/02/2009 and updated in May 2016. Previous: 1. Health Related Quality of Life (HRQL): 1.1. SF-36® Health Survey at 1 year 1.2. Euroqol EQ-5D, assessed annually until the end of 2009 1.3. Patient Generated Index at 1 year* 1.4. Stait-Trait Anxiety Index at 1 year* (*The TMC member with these skills moved to Norway and it was not possible to pursue these outcomes). (added 02/06/2016) 2. Durability of AAA grafts and incidence of complications and re-interventions, followed-up until the end of 2009 3. Costs and cost effectiveness. Data will be collected until the end of 2009. 4. Renal function, assessed annually until the end of 2009	—

Measure

Time frame

As of 27/05/2016: 1. Health Related Quality of Life (HRQL): 1.1. SF-36® Health Survey at 1 year 1.2. Euroqol EQ-5D, assessed annually until the end of 2009 2. Durability of AAA grafts and incidence of complications and re-interventions, followed-up until 2015 3. Costs and cost effectiveness. Data for costs will be collected until 2015 4. Renal function assessed annually until the end of 2009 Please note that methods of assessment for HRQL and the timepoints of assessment for all secondary outcome measures were added as of 06/02/2009 and updated in May 2016. Previous: 1. Health Related Quality of Life (HRQL): 1.1. SF-36® Health Survey at 1 year 1.2. Euroqol EQ-5D, assessed annually until the end of 2009 1.3. Patient Generated Index at 1 year* 1.4. Stait-Trait Anxiety Index at 1 year* (*The TMC member with these skills moved to Norway and it was not possible to pursue these outcomes). (added 02/06/2016) 2. Durability of AAA grafts and incidence of complications and re-interventions, followed-up until the end of 2009 3. Costs and cost effectiveness. Data will be collected until the end of 2009. 4. Renal function, assessed annually until the end of 2009

—

Countries

United Kingdom

Outcome results

None listed