Anatomical, physiological and inflammatory characterization of non-culprit vessels in patients undergoing primary PCI for ST-elevation myocardial infarction in the presence of multivessel disease: Rationale and design of the PICNIC study.
Authors
Affiliations (15)
Affiliations (15)
- Coronary & Structural Heart Research Group, University Hospital Southampton NHS Foundation Trust, Tremona Road, Southampton, SO16 6YD, United Kingdom. Electronic address: [email protected].
- Coronary & Structural Heart Research Group, University Hospital Southampton NHS Foundation Trust, Tremona Road, Southampton, SO16 6YD, United Kingdom. Electronic address: [email protected].
- Coronary & Structural Heart Research Group, University Hospital Southampton NHS Foundation Trust, Tremona Road, Southampton, SO16 6YD, United Kingdom. Electronic address: [email protected].
- Coronary & Structural Heart Research Group, University Hospital Southampton NHS Foundation Trust, Tremona Road, Southampton, SO16 6YD, United Kingdom. Electronic address: [email protected].
- Coronary & Structural Heart Research Group, University Hospital Southampton NHS Foundation Trust, Tremona Road, Southampton, SO16 6YD, United Kingdom. Electronic address: [email protected].
- Coronary & Structural Heart Research Group, University Hospital Southampton NHS Foundation Trust, Tremona Road, Southampton, SO16 6YD, United Kingdom. Electronic address: [email protected].
- University Hospitals Dorset NHS Foundation Trust, Castle Lane East, Bournemouth, BH7 7DW, United Kingdom. Electronic address: [email protected].
- Division of Cardiovascular Medicine, Level 6, West Wing, John Radcliffe Hospital, Headington, Oxford, OX3 9DU, United Kingdom. Electronic address: [email protected].
- Keele Cardiovascular Research Group, School of Medicine, David Weatherall Building, Keele University, Staffordshire, ST5 5BG, United Kingdom. Electronic address: [email protected].
- Department of Radiology, St Paul's Hospital, University of British Columbia, 1081 Burrard Street, Vancouver, BC, V6Z 1Y6, Canada. Electronic address: [email protected].
- HeartFlow Inc, 331 E Evelyn Ave, Mountain View, CA 94041, United States of America. Electronic address: [email protected].
- Seoul National University Hospital, 101 Daehak-ro, Jongno District, Seoul, South Korea. Electronic address: [email protected].
- Imperial College London, National Heart and Lung Institute, Dovehouse Street, London, SW3 6LY, United Kingdom. Electronic address: [email protected].
- Division of Informatics, Imaging and Data Sciences, Faculty of Biology, Medicine and Health, University of Manchester, Manchester, United Kingdom. Electronic address: [email protected].
- Coronary & Structural Heart Research Group, University Hospital Southampton NHS Foundation Trust, Tremona Road, Southampton, SO16 6YD, United Kingdom; School of Medicine, University of Southampton, University Road, Southampton, SO17 1BJ, United Kingdom. Electronic address: [email protected].
Abstract
Up to 50% of patients presenting with ST-elevation myocardial infarction (STEMI) have multivessel coronary artery disease (CAD). Randomized trials suggest that complete revascularization improves outcomes, but the mechanism and identification of patients who benefit remain unclear. This study aims to assess the association between blood and coronary imaging biomarkers and clinical events, to identify patient-, vessel-, and lesion-specific risk in STEMI patients with bystander disease. PICNIC is a multicenter, international, prospective observational study enrolling 320 patients with STEMI and multivessel CAD undergoing primary PCI of the culprit vessel without complete revascularization. Participants will undergo blood sampling for inflammatory markers and coronary CT angiography (CTCA) to assess: (i) plaque burden and morphology, (ii) artificial intelligence-enabled fractional flow reserve derived from CTCA (FFR<sub>CT</sub>) analysis of plaque and hemodynamic features, and (iii) fat attenuation index (FAI) to evaluate perivascular inflammation. The primary analysis will evaluate the association between a composite 24-month clinical endpoint (including all-cause mortality, myocardial infarction, ischemia-driven revascularization as first layer and cardiac arrest, heart failure, stroke, and ventricular tachyarrhythmia (second layer)) and: (a) serum inflammatory markers, and (b) anatomical and physiological characteristics of non-infarct-related arteries (NIRA) assessed by CTCA, FFR<sub>CT</sub>, and FAI. Statistical and machine learning methods will be applied to determine which combinations of clinical, imaging, and biomarker data best predict patient-, vessel-, and lesion-specific risk. PICNIC will characterize the anatomical, physiological, and inflammatory features of NIRA lesions in STEMI patients treated with culprit-only PCI in order to develop an AI-based risk prediction model. If such a model is successful it could be used to inform personalized revascularization strategies.