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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.
Heart failure
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Heart failure affects 1-2% of the population and is increasing in prevalence due to a growing. Ageing, a more sedentary population, and improved management of acute myocardial infarction (MI). Heart failure causes severe, debilitating symptoms, high rates of mortality, frequent long hospitalisations, and costs the NHS £2 billion per year (2% of the total NHS budget). Coronary artery disease (CAD) is the most common cause of heart failure, responsible for 52% of cases in patients under 75 years of age, and is the primary cause of heart failure with reduced ejection fraction (HFrEF).
In the UK, over 20,000 people per year with ischaemic left ventricular dysfunction (iLSVD) and CAD undergo revascularisation with coronary artery bypass grafting (CABG) or percutaneous angioplasty and stents (PCI). However, the choice of revascularisation strategy in heart failure is not guided by high quality evidence because most randomised controlled trials (RCTs) comparing effectiveness of CABG versus PCI included small numbers (1%-7%) of people with iLSVD. The evidence from these trials may not be generalisable to people with heart failure; observational analyses suggest that the risks and benefits for CABG and PCI are different in people with - versus people without heart failure.
No RCT has compared the effectiveness of PCI and CABG in people with iLSVD. The represents an important unmet need in a high risk population that experiences all-cause mortality rates of up to 30% at 5 years.
BCIS4 will compare PCI versus CABG for the revascularisation of patients with iLSVD (defined as LV ejection fraction (LVEF) <40% and multi-vessel coronary artery disease) who are deemed to derive clinical benefit from revascularisation.
The main hypothesis is that CABG is superior to PCI for the primary outcome all-cause death and cardiovascular hospitalisation with a minimum follow up of four years post randomisation.
An internal pilot will test design assumptions around recruitment at 12 months.
A health economic analysis will determine cost effectiveness.
The trial will contribute to data to the international STICH 3 analysis that will evaluate the comparative effectiveness of CABG versus PCI in iLSVD for the outcome all-cause mortality.
Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.
The recruitment start and end dates are as follows:
You can take part if:
You may not be able to take part if:
1. Decompensated heart failure requiring inotropic support, invasive or non-invasive ventilation or mechanical circulatory support less than 48 hours prior to randomisation 2. ST Elevation Myocardial Infarction (STEMI) <72 hours 3. Valvular heart disease or any other cardiac conditions (e.g., LV aneurysm) requiring surgery 4. Pregnancy5. Individuals who have declined access to Hospital Episode Statistics for research purposes 6. An inability to understand the languages in which the trial materials are provided
Below are the locations for where you can take part in the trial. Please note that not all sites may be open.
Mrs
Carla
Richardson
-
Bcis-4@leicester.ac.uk
The study is sponsored by University of Leicester and funded by NIHR Evaluation, Trials and Studies Co-ordinating Centre (NETSCC).
Your feedback is important to us. It will help us improve the quality of the study information on this site. Please answer both questions.
Or CPMS 61658
You can print or share the study information with your GP/healthcare provider or contact the research team directly.
