Early aortic repair in patients needing endovascular/open surgery for type B aortic dissection (EARNEST)
| ISRCTN | ISRCTN30838068 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN30838068 |
| IRAS number | 327350 |
| Secondary identifying numbers | CPMS 66215 |
- Submission date
- 30/01/2025
- Registration date
- 04/02/2025
- Last edited
- 04/02/2025
- Recruitment status
- Not yet recruiting
- Overall study status
- Ongoing
- Condition category
- Surgery
Plain English Summary
Background and study aims
Uncomplicated Type B Aortic Dissection (uTBAD) is a serious condition where the inner layer of the aorta tears, which can lead to long-term complications like aneurysms, aortic rupture, or further dissection. The standard treatment focuses on managing blood pressure, but some patients still face life-threatening issues over time. Thoracic Endovascular Aortic Repair (TEVAR) is a minimally invasive procedure that uses a stent to reinforce the aorta, potentially reducing these risks. The EARNEST trial aims to find out if early TEVAR, done within three months of the initial dissection, improves patient outcomes compared to standard medical management alone.
Who can participate?
Patients with uTBAD who are 10 days to 3 months post-hospital admission for the initial event can participate. Participants must be at least 18 years old, have a life expectancy of at least 2 years, and be discharged from high dependency or critical care. They must also be off opiate painkillers or sedatives for at least 48 hours before enrolling and willing to provide written informed consent.
What does the study involve?
This is a randomised controlled trial, meaning participants are randomly assigned to one of two groups by a computer. One group will receive a stent (TEVAR), while the other will receive standard care. All participants will receive standard UK care, including blood pressure monitoring and medication as needed. Those in the stented group will have the procedure between 10 days and 3 months after dissection. Follow-up visits will occur at 6 weeks, 6 months, and annually, with health assessments and questionnaires. Regular CT or MRI scans will monitor the aorta and any stents.
What are the possible benefits and risks of participating?
Participating in this trial may offer potential benefits, such as better overall outcomes from early TEVAR, though this cannot be guaranteed. The study aims to improve treatment for all patients with dissection in the future. Participants will have regular health check-ups and imaging, and any incidental findings will be reported to their GP.
Risks include procedural risks from TEVAR, such as bleeding, artery narrowing, wound infections, heart attack, pneumonia, blood clots, and reduced blood supply leading to stroke or other issues. Serious complications are rare, but they can occur. Both CT scans and TEVAR use ionising radiation, which carries a very small increased lifetime cancer risk.
Where is the study run from?
The study is run from Imperial College London (UK).
When is the study starting and how long is it expected to run for?
September 2024 to February 2034.
Who is funding the study?
NIHR HTA Programme (UK)
Who is the main contact?
Please contact the EARNEST study team at earnest@imperial.ac.uk.
Contact information
Scientific, Principal Investigator
Vascular Secretaries Office, Waller Cardiac Building, St Mary’s Hospital, Praed Street
London
W2 1NY
United Kingdom
| Phone | +44 20 3312 6666 |
|---|---|
| colin.bicknell@imperial.ac.uk |
Public
Imperial College Trials Unit & Division of Surgery
1st Floor, Stadium House, 68 Wood Lane
London
SW7 2AZ
United Kingdom
| Phone | +44 207 594 6017 |
|---|---|
| earnest@imperial.ac.uk |
Study information
| Study design | Parallel arm multicenter open label superiority randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Quality of life, Treatment, Safety, Efficacy |
| Participant information sheet | https://www.imperial.ac.uk/department-surgery-cancer/research/surgery/clinical-trials/earnest-study/ |
| Scientific title | Early Aortic Repair in patients Needing Endovascular/open Surgery for Type B Aortic Dissection (EARNEST): A randomised trial to assess the clinical and cost-effectiveness of thoracic endovascular aortic repair in the subacute phase after uncomplicated type B aortic dissection. |
| Study acronym | EARNEST |
| Study hypothesis | To determine whether early TEVAR in addition to BMT and surveillance compared to BMT and surveillance decreases the composite outcome of aortic-related mortality, severe permanent neurological deficit, or severe permanent cardiorespiratory failure over five years. |
| Ethics approval(s) |
Submitted 11/12/2024, Solihull Research Ethics Committee (Equinox House, City Link, East Midlands REC Centre, Birmingham, NG2 4LA, United Kingdom; +44 207 1048191; solihull.rec@hra.nhs.uk), ref: 327350/1701896/37/526 |
| Condition | Uncomplicated type B aortic dissection |
| Intervention | Study Design and Randomisation EARNEST is a multicentre, open-label, superiority randomised controlled trial (RCT) designed to assess the effectiveness of early intervention with Thoracic Endovascular Aortic Repair (TEVAR) combined with Best Medical Therapy (BMT) and Surveillance (SURV) compared to BMT and SURV alone in patients with uncomplicated Type B Aortic Dissection (uTBAD). Participants are allocated in a 1:1 ratio to one of the two study arms using a minimisation algorithm, which ensures balance across key prognostic factors (centre, age, and sex). Randomisation is conducted using a validated web-based system, Sealed Envelope. Blinding is not possible due to the nature of the intervention; however, endpoint adjudication will be carried out by an independent expert panel • Study Arms 1. TEVAR + BMT + SURV Group (Intervention Arm) • Treatment: Participants undergo Thoracic Endovascular Aortic Repair (TEVAR) within 3 months of the index uTBAD event. TEVAR is performed at 25 specialist vascular centres across the UK. • Follow-up Duration: Minimum of 5 years post-enrolment. • Surveillance & Assessments: o CT/MRI at 6 weeks , 12 months, 1, 2, 3, 4, 5 years o Follow-ups at 6 weeks, 6 months, 1 year, and annually up to 5 years. 2. BMT + SURV Group (Control Arm) • Treatment: Participants receive Best Medical Therapy (BMT) and clinical surveillance without TEVAR, unless clinically indicated per existing guidelines. • Follow-up Duration: Minimum of 5 years post-enrolment. • Surveillance & Assessments: o CT/MRI at 6 weeks , 12 months, 1, 2, 3, 4, 5 years o Follow-ups at 6 weeks, 6 months, 1 year, and annually up to 5 years. o Late TEVAR intervention is permitted only if clinically necessary. Randomisation Process • 470 participants will be randomised 1:1 using a minimisation algorithm with a random component. • The algorithm is stratified by age, sex, and centre to ensure balance across the study arms. • Randomisation is conducted via a web-based system (Sealed Envelope). |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | Time to first of aortic-related mortality AND/OR severe permanent neurological deficit AND/OR severe permanent cardiorespiratory failure measured using patient records throughout follow up from randomisation until the first composite event. Patients censored if there is a competing event (non-aortic-related death, patient withdrawal or end of the study). Reported when all patients are five years after randomisation |
| Secondary outcome measures | 1. Aortic-related mortality is measured using patient records at one year for the TEVAR group and five years after randomisation for all patients 2. All-cause mortality is measured using patient records at one year for the TEVAR group and five years after randomisation for all patients 3. Complications including stroke, paraplegia, and cardiorespiratory failure are measured using patient records throughout follow up and reported at one year for the TEVAR group and five years after randomisation for all patients 4. Reinterventions are measured using patient records throughout follow up and reported at one and five years after randomisation 5. Quality of Life (QoL) is measured using EQ-5D-5L questionnaires at baseline, 6 weeks, 6 months, 12 months, and then annually from randomisation until the end of follow up 6. Aortic remodelling is measured using CT/MRI scans assessed using a specific CT analysis protocol from the core lab at one year after TEVAR in the intervention group and at five years 7. Costs are measured using health resource use and cost data at 6 weeks, 6 months, 12 months, and then annually from randomisation and analysed at 5 years 8. Cost-effectiveness is measured using health resource use and cost data at 6 weeks, 6 months, 12 months, and then annually from randomisation and analysed at 5 years 9. Controlled blood pressure is measured using blood pressure recordings at baseline, 6 weeks, 6 months, 12 months, and then annually from randomisation until the end of follow up and analysed at 5 years |
| Overall study start date | 01/09/2024 |
| Overall study end date | 01/02/2034 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 470 |
| Participant inclusion criteria | 1. Patients with uTBAD, 10 days-3 months after the day of admission with acute uTBAD to hospital (the date of the index event) 2. Age ≥18 years 3. Life expectancy ≥2 years |
| Participant exclusion criteria | 1. Complicated TBAD (ruptured aorta, aortic dilatation >5cm or visceral/limb/spinal malperfusion, persistent pain or uncontrolled BP). 2. Previous TBAD. 3. Type A dissection 4. At significant risk from complications (either from condition related to the dissection or not – rephrase) during TEVAR |
| Recruitment start date | 01/09/2025 |
| Recruitment end date | 01/09/2029 |
Locations
Countries of recruitment
- England
- Northern Ireland
- United Kingdom
Study participating centres
St Marys Hospital
South Wharf Road
London
W2 1BL
United Kingdom
London
SW3 6NP
United Kingdom
Freeman Road
High Heaton
Newcastle upon Tyne
NE7 7DN
United Kingdom
Infirmary Square
Leicester
LE1 5WW
United Kingdom
Stoke-on-trent
ST4 6QG
United Kingdom
The Royal London Hospital
Whitechapel
London
E1 1BB
United Kingdom
A Floor - Belfast City Hospital
Lisburn Road
Belfast
BT9 7AB
United Kingdom
Cambridge Biomedical Campus
Hills Road
Cambridge
CB2 0QQ
United Kingdom
St Thomas Street
London
SE1 9RT
United Kingdom
Anlaby Road
Hull
HU3 2JZ
United Kingdom
Beckett Street
Leeds
LS9 7TF
United Kingdom
Prescot Street
Liverpool
L7 8XP
United Kingdom
Manchester
M13 9WL
United Kingdom
Nethermayne
Basildon
SS16 5NL
United Kingdom
Colney Lane
Colney
Norwich
NR4 7UY
United Kingdom
Derby Road
Nottingham
NG7 2UH
United Kingdom
Old Road
Headington
Oxford
OX3 7LE
United Kingdom
Pond Street
London
NW3 2QG
United Kingdom
Mindelsohn Way
Edgbaston
Birmingham
B15 2GW
United Kingdom
Southmead Road
Westbury-on-trym
Bristol
BS10 5NB
United Kingdom
Clifford Bridge Road
Coventry
CV2 2DX
United Kingdom
Tremona Road
Southampton
SO16 6YD
United Kingdom
Lyndhurst Road
Worthing
BN11 2DH
United Kingdom
Sponsor information
University/education
Research Governance and Integrity Team (RGIT) Room 215, Level 2, Medical School Building, St Mary’s Campus, Norfolk Place
London
SW7 2AZ
England
United Kingdom
| Phone | +44 2075949832 |
|---|---|
| rgit@imperial.ac.uk | |
| Website | https://www.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
Results and Publications
| Intention to publish date | 01/02/2034 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Published as a supplement to the results publication |
| Publication and dissemination plan | We will aim to present the findings from the study to the Vascular Society, British Society of Endovascular Therapy, American Heart Association and the European Society of Vascular Surgery. We will aim to publish the findings of the trial in widely disseminated high impact academic journals. |
| IPD sharing plan | All data generated or analysed during this study will be included in the subsequent results publication |
Editorial Notes
04/02/2025: Trial's existence confirmed by the National Institute for Health and Care Research (NIHR) (UK).
