Randomised controlled multi centre trial comparing two standard of care revascularisation treatments, either percutaneous angioplasty and stents (PCI) or coronary artery bypass grafting (CABG), in patients who have been diagnosed with a condition that reduces heart function known as ischaemic left ventricular dysfunction (ilSVD) as well as coronary artery disease (CAD)

Plain English summary of protocol

Background and study aims
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.

Who can participate?
Males and females over 18 years.
LVEF <40% quantified by a recognised assessment of LVEF within the last 12 months
If a MI has occurred within 12 months post MI-imaging is required with LVEF <40%.
Significant amount of myocardium at risk, defined as coronary artery disease with BCIS myocardial jeopardy score >6 on recent (<6 months) coronary angiogram.

What does the study involve?
Once consent has been obtained the participant will be randomised on a 1:1 ratio to either revascularisation by Percutaneous Angioplasty and Stents (PCI) or revascularisation by Coronary Artery Bypass Grafting (CABG).
Participants will be asked to attend hospital twice (including for the intervention). Three months after the intervention a review of medication will take place along with four trial questionnaire.
After six months and every six months up to four years two the participants will be asked to complete two trial questionnaires related to quality of life and access to healthcare. The review of medication and questionnaires will be performed using either ResearchApp™ of Healthbit® (smartphone app) or over the telephone with the research team.

What are the possible benefits and risks of participating?
There are no guaranteed direct benefits to taking part in the trial. The participant's condition may remain the same, improve or worsen. However, given that the research team will be in touch with the participants regularly, they may receive more regular care compared to
someone who is not taking part.
Both PCI and CABG are standard of care and taking part in this trial presents no added risk to that which a patient would experience being treated outside of the trial. As we do not know whether it is better for patients to received PCI or CABG, we do not know for sure if there are any disadvantages.
CABG is a major undertaking which carries a higher risk and requires a longer recovery period and may not be suitable for everyone. However, in people without iLSVD, CABG reduces the rate of death and repeat heart attacks in the long-term compared to stenting.
PCI is minimally invasive, and a simpler procedure with fewer risks, and a quicker recovery.
However, the long-term results of stents are often not as good and over time it may become necessary to repeat the procedure.

Where is the study run from?
Leicester Clinical Trials Unit (UK)

When is the study starting and how long is it expected to run?
April 2024 to March 2032

Who is funding the study?
Trial's existence confirmed by the National Institute for Health and Care Research (NIHR) (UK).

Who is the main contact?
Luke Ingram/Cathy Young, bcis-4@leicester.ac.uk

Contact information

Study information

Eligibility

Locations

Countries of recruitment

• England
• Northern Ireland
• Scotland
• United Kingdom

Study participating centres

Sponsor information

University of Leicester
University/education

University Road
Leicester
LE1 7RH
England
United Kingdom

Phone	+44 1162584393
Email	RGOsponsor@leicester.ac.uk
Website	http://www.le.ac.uk/
"ROR"	https://ror.org/04h699437

Funders

Funder type

Government

Results and Publications

Study outputs

Additional files

45538 STICH3-BCIS4 PIS_v1.1_10Apr24.pdf

Editorial Notes

29/05/2024: Trial's existence confirmed by the National Institute for Health and Care Research (NIHR) (UK).