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Clinical research

Complete Versus culprit-Lesion only PRimary PCI Trial (CVLPRIT): a multicentre trial testing management strategies when multivessel disease is detected at the time of primary PCI: rationale and design

1. Department of Cardiology, University Hospitals of Leicester, Leicester, United Kingdom; 2. NIHR Leicester Cardiovascular Biomedical Research Unit, Leicester, United Kingdom; 3. Department of Cardiology Jubilee Wing, Leeds General Infirmary, Leeds, United Kingdom; 4. Department of Cardiology, Southampton University Hospitals NHS Trust, Southampton, United Kingdom; 5. Department of Cardiology, Royal Brompton & Harefield NHS Foundation Trust, Harefield Hospital, Harefield, Middlesex, United Kingdom; 6. Department of Cardiology, Kettering General Hospital, Kettering, United Kingdom; 7. Clinical Trials & Evaluation Unit, Royal Brompton & Harefield NHS Foundation Trust, London, United Kingdom; 8. University College London Hospitals NHS Foundation Trust, London, United Kingdom; 9. Papworth Hospital NHS Foundation Trust, Cambridge, United Kingdom; 10. University Hospital of North Staffordshire NHS Trust, Stoke-on-Trent, United Kingdom; 11. Norfolk and Norwich Hospitals NHS Trust, Norwich, United Kingdom

Aims: Primary percutaneous coronary intervention (PPCI) is the preferred strategy for acute ST-segment elevation myocardial infarction (STEMI), with evidence of improved clinical outcomes compared to fibrinolytic therapy. However, there is no consensus on how best to manage multivessel coronary disease detected at the time of PPCI, with little robust data on best management of angiographically significant stenoses detected in non-infarct-related (N-IRA) coronary arteries. CVLPRIT will determine the optimal management of N-IRA lesions detected during PPCI.

Methods and results: CVLPRIT (Complete Versus culprit-Lesion only PRimary PCI Trial) is an open-label, prospective, randomised, multicentre trial. STEMI patients undergo verbal “assent” on presentation. Patients are included when angiographic MVD has been detected, and randomised to culprit (IRA)-only PCI (n=150) or in-patient complete multivessel PCI (n=150). Cumulative major adverse cardiac events (MACE) - all-cause mortality, recurrent MI, heart failure, need for revascularisation (PCI or CABG) will be recorded at 12 months. Secondary endpoints include safety endpoints of confirmed ischaemic stroke, intracranial haemorrhage, major non-intracranial bleeding, and repair of vascular complications. A cardiac magnetic resonance (CMR) substudy will provide mechanistic data on infarct size, myocardial salvage index and microvascular obstruction. A cost efficacy analysis will be undertaken.

Conclusions: The management of multivessel coronary artery disease in the setting of PPCI for STEMI, including the timing of when to perform non-culprit-artery revascularisation if undertaken, remains unresolved. CVLPRIT will yield mechanistic insights into the myocardial consequence of N-IRA intervention undertaken during the peri-infarct period.

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