EARNEST
Research type
Research Study
Full 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.
IRAS ID
327350
Contact name
Colin D Bicknell
Contact email
Sponsor organisation
Imperial College London
Duration of Study in the UK
9 years, 5 months, 0 days
Research summary
Type-B aortic dissection (TBAD) is a sudden, painful, life-threatening tear in the lining of the aorta, the main blood vessel in the body, creating a false channel that runs downwards in the chest. About 7/10 patients do not have an immediate life-threatening complication (uncomplicated [uTBAD]). Current standard care is best medical therapy (BMT) with tablets to control the blood pressure (BP) and yearly aortic scans.
One third develop a bulge in the aorta called an aneurysm, which can burst leading to life-threatening internal bleeding. Repair of the aorta is offered if the aneurysm is at risk of rupture (usually 6cm in size), but this complex operation carries significant risk.
An early procedure called thoracic endovascular aortic repair (TEVAR) instead of monitoring might be better. TEVAR relines the aorta and closes the tear, obliterating the false channel. TEVAR is only possible in the first few months before the aorta becomes stiff. The procedure allows the aorta to heal and avoids aneurysm formation. However, there are operative risks and some are subjected to a procedure even though there would not have been late aneurysm formation.
This trial will test whether there is a long-term benefit from undergoing TEVAR early after uTBAD to prevent long-term complications. 470 consenting patients with uTBAD will be randomly allocated into two groups in a randomised controlled trial. The control group will have standard care, and our intervention group will have early TEVAR and BMT.
The intervention group will undergo TEVAR at 10-days to 3-months after uTBAD. Patients in the control group who have expansion of the aorta will only be treated later if there is aortic expansion or complications.
All participants will be followed up for 5-years. The main outcome is a combination of death due to aortic disease, severe stroke, paralysis, or severe heart/lung disease.
REC name
West Midlands - Solihull Research Ethics Committee
REC reference
25/WM/0005
Date of REC Opinion
13 Feb 2025
REC opinion
Further Information Favourable Opinion