A multicentre randomised trial of surgical versus percutaneous revascularisation of ischaemic left ventricular dysfunction in the United Kingdom, with embedded internal pilot and health economic analysis (BCIS4)
Surgeons and cardiologists have long disagreed about whether to bypass blocked heart arteries with open-chest surgery or to prop them open with a stent through a catheter—and a new UK trial will settle the question for patients whose hearts have already been weakened by poor blood flow. The problem is that roughly half of patients with heart failure also have clogged coronary arteries, yet no high-quality evidence tells doctors which revascularisation method—coronary artery bypass grafting (CABG) or percutaneous coronary intervention (PCI)—improves survival and reduces hospital stays. Current practice varies wildly across the country, meaning a patient’s treatment depends more on where they live than on what works best. The BCIS4 trial will randomly assign 630 patients with a left ventricular ejection fraction of 40% or less to either CABG or PCI, then track deaths and cardiovascular hospitalisations for up to five years. An embedded health economic analysis will determine which approach gives the NHS better value for money. If CABG proves superior, guidelines will shift toward surgery for this vulnerable group, potentially preventing thousands of avoidable deaths and hospital admissions each year. If PCI matches surgery, patients could avoid the risks and recovery time of open-heart surgery while achieving the same outcomes.
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Research question Is revascularisation with coronary artery bypass grafting (CABG) superior to percutaneous coronary intervention (PCI) in people with ischaemic left ventricular dysfunction (iLVSD) with respect to all-cause mortality or cardiovascular hospitalisation, and more cost effective? Background The choice of revascularisation with CABG versus PCI in people with iLVSD is not guided by high quality evidence. There is wide variation in care and outcomes. Aims and objectives BCIS4 will compare CABG versus PCI for the revascularization of patients with iLVSD defined as LV ejection fraction = 40% and multi-vessel coronary artery disease. A health economic analysis will determine cost-effectiveness. An internal pilot will evaluate expected recruitment rates. A PPI researcher led work package will improve recruitment in underserved groups. BCIS4 will contribute 30% of the international STICH3 trial cohort, which aims to test superiority of CABG versus PCI in iLVSD for the outcome All-Cause Mortality. Methods Design: Multicentre, open label, parallel group, RCT of two common revascularisation strategies in people with iLVSD. Target population: Adults with iLVSD for which revascularization is deemed appropriate and suitable with both PCI and CABG by the local Heart Team are eligible. People with valvular or structural heart disease requiring surgery, or for whom dual anti-platelet therapy is contraindicated, are excluded. Health technologies being assessed: Study participants will be randomised using concealed allocation in a 1:1 manner to revascularization either by PCI OR CABG. Primary Effectiveness Outcome: All-cause mortality or cardiovascular hospitalisation. Disease specific Patient Reported Outcomes Measures will include the Kansas City Cardiomyopathy Questionnaire and the Cardiovascular Revascularisation Outcomes Questionnaire. Health Economic Outcomes: A bespoke questionnaire will record healthcare resource use. The EuroQol EQ-5D-5L will capture health-related quality of life. The Productivity Cost Questionnaire Patient will capture patient productivity losses. Follow-up: Up to 5 years post randomisation. Sample Size: Using a time-to-event analysis to detect a Hazard Ratio of 0.7 for the primary outcome with a 1:1 allocation ratio, 90% power, and a 2-sided alpha value of 0.05, a total of 414 events or 630 participants (n=315 in each arm) will be required. Target Recruitment: 0.7 participants/ site/ month for 41 months in at least 28 UK sites. Internal Pilot: The primary progression criteria is recruitment of 0.7 pts/site/month in 18 sites within 12 months of green light. Primary Analysis of the primary outcome will be by intention to treat and use time to event analysis. Health Economic Evaluation will determine the cost-effectiveness of CABG, compared with PCI, from the perspectives of the UK NHS, personal social services, and the wider societal perspective. We will conduct the evaluation alongside the clinical trial over a 5-year time horizon and a model-based evaluation over a lifetime horizon. Timelines for delivery Start Date 1st October 2023. Months 1-4 set-up, months 5-45 recruitment, months 46 to 93 follow-up to LPLV, months 94 to 97 data cleaning, data lock, months 97 to 101 analysis, site closedown, dissemination. Anticipated impact and dissemination An unbiased comparison of CABG versus PCI will inform international guidelines and clinicians of the relative benefits of these interventions in people with iLVSD.
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