REvascularisation for heart failure with PReserved ejection fraction and Ischaemia: EValuation of Efficacy and mechanistic Description (REPRIEVED)
Heart failure with preserved ejection fraction (HFpEF) and coronary artery disease
Patients with HFpEF and coronary artery disease will be randomised 1:1 using an online randomisation system to either PCI (intervention group) or placebo procedure (control group) using an online randomisation system in permuted blocks of varying size and stratified by recruiting site. Intervention group: Participants will receive percutaneous coronary intervention (PCI) as per current standard of care. Control group: Participant will undergo a placebo PCI procedure that involves placement of a thin tube to image the blood vessel but does not involve placement of an actual stent.
1. A diagnosis of HFpEF, defined by the European Society of Cardiology (ESC) criteria, as: 1.1. Symptoms of heart failure (New York Heart Association (NYHA) class II-IV) and 1.2. Left ventricular ejection fraction >=50% and 1.3. One or more of the following objective signs of left ventricular diastolic dysfunction: 1.3.1. Invasively measured left ventricular end diastolic pressure >=15 mmHg at rest or >=25 mmHg on exercise (directly measured or estimated via pulmonary capillary wedge pressure) 1.3.2. Estimated pulmonary artery systolic pressure > 35mmHg or tricuspid regurgitation velocity >2.8 m/s on echocardiography 1.3.3. Left atrial volume index >34ml/m2 in patient in sinus rhythm or left atrial volume index >40 ml/m2 in atrial fibrillation 1.3.4. Relative left ventricular wall thickness >0.42 1.3.5. Left ventricular mass index >=95 g/m2 in females or >=115 g/m2 in males 1.3.6. Mitral E/E’ ratio > 9 and 1.4. NT-pro-BNP >125 pg/ml in sinus rhythm or >365 pg/ml in atrial fibrillation plus 2. Significant coronary artery disease defined as: 2.1. Functionally significant disease in at least one major proximal epicardial coronary artery (British Cardiovascular Intervention Society Jeopardy Score >=4) with a fractional flow reserve (FFR) <=0.80 measured with FFR, estimated with computational fluid dynamics during invasive angiography (e.g. VFR) or CT-FFR.
1. Age <18 years 2. People without capacity to provide informed consent 3. PCI contraindicated or not feasible on coronary angiography or screening CTCA 4. Contraindication to clopidogrel/dual antiplatelet therapy 5. Recent acute myocardial infarction or coronary revascularisation (within 90 days) 6. Enrolment in another interventional study which may affect study outcomes 7. Severe chronic obstructive pulmonary disease (GOLD stage >=3) 8. Haemoglobin <=80 g/L 9. Other cardiac diagnosis as a cause for HFpEF (hypertrophic cardiomyopathy, untreated severe left sided valvular disease, cardiac amyloidosis)