Extrait

Background and study aims A novel treatment called transcatheter aortic valve implantation (TAVI) now allows patients who are too high risk to undergo open-heart surgery to have their very stiff heart valves (the aortic valve) replaced. This is achieved using a valve replacement put in place using a balloon, introduced through only a small cut into an artery or the heart itself. The process which leads to this stiffening of the valve is related to that which leads to narrowing within the heart’s coronary arteries. In patients undergoing open-heart surgery to replace the valve, any such narrowings can be treated at the same time using a technique called bypass grafting or a ‘heart bypass’. This has been shown to be better than not treating these arteries. However, we do not know the best treatment for these narrowed arteries in patients undergoing TAVI. In these patients the alternative to heart bypass surgery is to use a balloon and stent(s) to widen the artery and relieve the narrowing (percutaneous coronary intervention or PCI). This is achieved using very thin tubes passed to the heart either via an artery in the groin or the wrist. However, this has its own risks and it may be better for the patient to not have these narrowings opened until they present the main problem. Who can participate? Patients must be 18 years of age or over with severe aortic stenosis. What does the study involve? We will randomly assign 310 patients with significant narrowing in their coronary arteries to either undergo PCI or to not undergo PCI. We will then follow these patients up, as well as patients without significant narrowings and those who cannot have the PCI procedure performed. The aim is to answer the question of whether patients with significant narrowings of their coronary arteries who are due to undergo a TAVI for a severely stiffened aortic heart valve should have stenting first, or not. The study compares the effects of treating or not treating coronary artery disease using stenting prior to TAVI. What are the possible benefits and risks of participating? There is no direct benefit to study participants, clinical or otherwise. The information we will get will help improve the treatment of other people with similar conditions in the future. We do not know if the stenting has any beneficial or negative effects upon patients undergoing TAVI. The possible risks of undergoing the stenting procedure are similar to that of your coronary angiogram: blockage of the stent by a process known as thrombosis and excess ‘healing’ of the artery wall causing ‘restenosis’ of the stent. Other major complications are uncommon, but include: death, heart attack, which may require emergency heart bypass, stroke and bleeding. Minor complications are: allergy to the contrast medium, impairment of kidney function and complications at the access site, such as bleeding and haematoma. The risks of stenting are much lower than the risks associated with the TAVI procedure. Where is the study run from? The lead centre for the trial is the Cardiovascular Department, Guy’s & St Thomas NHS Foundation Trust, London, UK. The total number of centres involved is to be confirmed. It will involve centres across the UK and the EU. When is the study starting and how long is it expected to run for? We expect to begin recruitment of patients in late 2011 and will follow up the patients for 12 months. The expected duration of the trial is 3 years. Who is funding the study? The trial is funded by educational grants provided by Boston Scientific Inc. (MA, USA) and Edwards LifeSciences (CA, USA). Who is the main contact? Dr Martyn R Thomas [email protected]

Critère d'inclusion

• Coronary artery disease, aortic stenosis

Liens

• ictrp
• isrctn