Endovascular aneurysm repair (EVAR) trials 1 and 2
| ISRCTN | ISRCTN55703451 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN55703451 |
| Secondary identifying numbers | HTA 95/02/99; HTA 95/02/02; HTA 11/36/46 |
- Submission date
- 25/04/2003
- Registration date
- 25/04/2003
- Last edited
- 14/02/2018
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Plain English Summary
Background and study aims
Abdominal aortic aneurysm is a condition where the aorta, which is the main artery that leaves the heart and travels down towards the legs, starts to bulge and expand at a section just below the diaphragm, level with the navel. If the bulge continues to expand, it can rupture and this can lead to an emergency operation and often results in death. Studies have shown that if the aneurysm increases to a certain size the risk of rupture, which is generally low, starts to increase and a planned operation can be performed to repair the bulging section of aorta. There are two ways of repairing this section and doctors are unsure which method is better. The open repair method is the tried and trusted method as it has been around for about 50 years and is known to be durable and last for the rest of most patients’ lives. However, it is quite a serious operation which generally involves a longer stay in hospital and a slightly higher chance of dying within 30 days of the operation when compared to a new method called EndoVascular Aneurysm Repair (EVAR). This new method is less of a strain on the patient’s body which results in a shorter recovery time and a better chance of surviving within the first 30 days after the procedure. The downside of this new procedure is that it is more common for there to be problems following the operation that may require further small procedures to correct them. In some cases, patients are not considered fit enough for the open repair operation as it may be too much of a strain on their body and always requires a general anaesthetic. For these patients, doctors are not sure whether repairing the aneurysm using an EVAR would be best for these patients or whether they would be better treated with regular scans of the aneurysm and given medication to try and improve their fitness. Thus, two studies have been set up to test the new endovascular method in two clinical situations: when the patient is considered fit for an open repair and when the patient is considered unfit for an open repair.
Who can participate?
Patients aged at least 60 with an abdominal aortic aneurysm considered fit for an open repair (EVAR Trial 1) or considered unfit for an open repair (EVAR study 2)
What does the study involve?
In EVAR study 1 participants considered fit for an open repair are randomly allocated to receive either an open repair or the new EVAR procedure, and these two groups are then compared to see how they get on. In EVAR study 2 participants considered unfit for an open repair are randomly allocated to receive either an EVAR with standard medical treatment or medical treatment alone, and these two groups are then compared to see how they get on. Mortality (number of deaths), quality of life, durability and cost-effectiveness are assessed.
What are the possible benefits and risks of participating?
Not provided at time of registration
Where is the study run from?
Charing Cross Hospital (UK)
When is the study starting and how long is it expected to run for?
July 1999 to August 2016
Who is funding the study?
1. NIHR Health Technology Assessment Programme - HTA (UK)
2. Camelia Botnar Arterial Research Foundation
Who is the main contact?
Prof. Roger Greenhalgh
r.greenhalgh@imperial.ac.uk
Contact information
Scientific
Department of Surgery
Charing Cross Hospital
London
W6 8RF
United Kingdom
| Phone | +44 (0)20 3311 7315 |
|---|---|
| r.greenhalgh@imperial.ac.uk |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | EndoVascular Aneurysm Repair (EVAR) randomised controlled trial in patients with abdominal aortic aneurysm (EVAR 1 and 2) |
| Study acronym | EVAR |
| Study hypothesis | Endovascular Aneurysm Repair (EVAR) to exclude Abdominal Aortic Aneurysm (AAA) was introduced in the early 1990s for patients of poor health status considered unfit for major surgery. As the technology has progressed, EVAR has become an alternative choice of treatment for patients considered fit for open repair as it is minimally invasive and generally involves a shorter stay in hospital. The two EndoVascular Aneurysm Repair (EVAR) Trials were instigated to assess the safety and efficacy of endovascular aneurysm repair in the treatment of AAA in terms of mortality, quality of life, durability and cost-effectiveness for patients considered fit (EVAR Trial 1) or unfit (EVAR Trial 2) for open repair. Added on 27/05/2016: 30-day mortality results were reported in 2004, mid-term results in 2005 and long-term follow-up out to 8 years in 2010. In 2012 the NIHR awarded further funding to extend follow-up out to 15 years because of uncertainty about the long-term durability of EVAR. |
| Ethics approval(s) | MREC North West (original), 28/04/1998 Approval (via an amendment) for extended follow-up to 15 years on 26/01/2011 EVAR Trial 1, ref: 98/8/26 EVAR Trial 2, ref: 98/8/27 |
| Condition | Cardiovascular diseases: peripheral arterial disease |
| Intervention | 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 As of 27/05/2016: Randomisation closed at the end of August 2004 by which time 1656 patients had been enrolled (1252 into EVAR Trial 1 and 404 into EVAR Trial 2). Follow-up was completed in 2015. Data for the 30-day mortality analysis were based upon the 1082 patients randomised to 31/12/2003 (last sentence added 02/06/2016) Between 01/09/2004 and the publication of mid-term results on 15/06/2005, there was a separate study which randomised 175 patients to either open or endovascular repair (EVAR 1 follow on) and 56 patients to either endovascular repair or no intervention (EVAR 2 follow on) (total 231) Previous: Randomisation closed at the end of June 2005 by which time 1486 patients had been enrolled (1082 into EVAR Trial 1 and 404 into EVAR Trial 2). Follow-up continues until the end of 2009. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | 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 outcome measures | 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 |
| Overall study start date | 01/07/1999 |
| Overall study end date | 31/08/2016 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Sex | Both |
| Target number of participants | EVAR 1: Between 1448 and 2205; EVAR 2: 440 (original protocol 1999) |
| Participant 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 |
| Participant 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. |
| Recruitment start date | 01/07/1999 |
| Recruitment end date | 31/08/2004 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
W6 8RF
United Kingdom
Sponsor information
University/education
South Kensington Campus
London
SW7 2AZ
England
United Kingdom
| Website | http://www3.imperial.ac.uk/ |
|---|---|
"ROR" |
https://ror.org/041kmwe10 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- NIHR Health Technology Assessment Programme, HTA
- Location
- United Kingdom
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Other publications | publication on trial design, methodology and progress | 01/04/2004 | Yes | No | |
| Results article | results on 30-day operative mortality | 01/09/2004 | Yes | No | |
| Results article | results of EVAR trial 1 | 01/06/2005 | Yes | No | |
| Results article | results of EVAR trial 2 | 01/06/2005 | Yes | No | |
| Results article | results on patient fitness and survival | 01/06/2007 | Yes | No | |
| Results article | device-specific results of secondary interventions and mortality | 01/09/2007 | Yes | No | |
| Results article | results on the rupture rate of large abdominal aortic aneurysms | 01/01/2008 | Yes | No | |
| Results article | results on long-term cost-effectiveness | 01/02/2008 | Yes | No | |
| Results article | results on rate of cardiovascular events in EVAR trial 2 | 01/04/2010 | Yes | No | |
| Results article | results on endovascular repair in patients physically ineligible for open repair | 20/05/2010 | Yes | No | |
| Results article | results on endovascular versus open repair | 20/05/2010 | Yes | No | |
| Results article | results on EVAR versus standard therapy | 01/11/2012 | Yes | No | |
| Results article | results on the rate and predictability of graft rupture | 01/11/2010 | 02/06/2016 | Yes | No |
| Results article | 15-years' follow-up results | 12/11/2016 | Yes | No | |
| Results article | long-term follow-up results | 01/01/2018 | Yes | No |
Editorial Notes
14/02/2018: Publication reference added.
17/10/2016: Publication reference added.
24/06/2016: Plain English summary added.
02/06/2016: Record has undergone some minor amendments to interventions and secondary outcome measures. The study contact telephone number has been changed, a new publication has been added and an additional funder has been included. All amendments have been timestamped.
27/05/2016: Record has undergone a number of changes including to the following fields (date stamped): study hypothesis, interventions, outcome measures, exclusion criteria. Recruitment end date changed from 30/06/2010 to 31/08/2004. Total target enrollment of participants changed from 1180 to 2645. Ethics approval amendment date added. Added publication citation.
21/03/2016: The study website URL has been updated.
26/01/2016: The overall trial end date has been updated from 30/06/2010 to 31/08/2016.
03/02/2009: Please note that the scientific title has been added.
