Mechanical circulatory support in high-risk elective PCI: rationale and design of the PROTECT IV trial

Coronary artery disease (CAD) is the leading cause of heart failure with reduced ejection fraction (HFrEF). Coronary artery bypass grafting (CABG) improves long-term mortality in HFrEF. Percutaneous coronary intervention (PCI) is often performed as an alternative to CABG in patients at high surgical risk. However, in patients with HFrEF and limited myocardial reserve, PCI may result in haemodynamic instability, increasing risk and precluding optimal revascularisation. Mechanical circulatory support (MCS) during high-risk PCI may enhance haemodynamic stability during the procedure and enable complete revascularisation. We thus performed the PROTECT IV trial to determine whether PCI with routine use of the Impella CP microaxial flow pump improves early and late outcomes in patients with HFrEF and complex CAD compared with PCI with or without use of an intra-aortic balloon pump (IABP). PROTECT IV is a prospective, multicentre, randomised, parallel-controlled, open-label, superiority trial with an adaptive design. Patients with complex CAD and left ventricular ejection fraction ≤40% (n=1,252) deemed at excessive surgical risk for bypass grafting by the Heart Team will be randomised in a 1:1 ratio to PCI with Impella CP versus PCI with or without an IABP. The primary endpoint is the composite of all-cause death, stroke, myocardial infarction, unplanned clinically driven revascularisation, durable left ventricular assist device implant or heart transplant, or other hospitalisation for cardiovascular causes at 3-year follow-up, with at least 1-year follow-up in all patients. Prespecified substudies will evaluate the impact of MCS on renal function, the procedural role of right heart catheterisation, and the utility of myocardial viability assessment. The PROTECT IV trial will determine whether routine MCS with Impella CP during high-risk PCI improves the prognosis of patients with complex CAD and HFrEF.

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Publication Details

Journal
EuroIntervention
Published
2025-10-28
DOI
https://doi.org/10.4244/eij-d-25-00486
Citations
4
Primary Topic
Cardiac pacing and defibrillation studies
Type
article
Field-Weighted Citation Impact
5.55
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article

Mechanical circulatory support in high-risk elective PCI: rationale and design of the PROTECT IV trial

William W. O’Neill, Navin Kumar Kapur, Jagat Narula, Ehtisham Mahmud et al.
4 citations
EuroIntervention
Cardiac pacing and defibrillation studies
5.55
article

Mechanical circulatory support in high-risk elective PCI: rationale and design of the PROTECT IV trial

William W. O’Neill, Navin Kumar Kapur, Jagat Narula, Ehtisham Mahmud, Dana Bentley, Giuseppe Tarantini, Mir B. Basir, Rose Chapman, Stuart Pocock, Jason Wollmuth, Stephan Achenbach, Alexandra J. Lansky, Cindy L. Grines, Ziad A. Ali, Gregg W. Stone, Stephan Windecker, Dimitrios Karmpaliotis, George Dangas, Haroon Faraz, Jeffrey W. Moses, Amir Kaki, Seth Bilazarian, Jeffrey J. Popma, Akiko Maehara, Aditya Bharadwaj, Chuck Simonton, Sanjeev Sharma, Chris O'Connor, Norman Mangner
article en
4 citations

Abstract

Coronary artery disease (CAD) is the leading cause of heart failure with reduced ejection fraction (HFrEF). Coronary artery bypass grafting (CABG) improves long-term mortality in HFrEF. Percutaneous coronary intervention (PCI) is often performed as an alternative to CABG in patients at high surgical risk. However, in patients with HFrEF and limited myocardial reserve, PCI may result in haemodynamic instability, increasing risk and precluding optimal revascularisation. Mechanical circulatory support (MCS) during high-risk PCI may enhance haemodynamic stability during the procedure and enable complete revascularisation. We thus performed the PROTECT IV trial to determine whether PCI with routine use of the Impella CP microaxial flow pump improves early and late outcomes in patients with HFrEF and complex CAD compared with PCI with or without use of an intra-aortic balloon pump (IABP). PROTECT IV is a prospective, multicentre, randomised, parallel-controlled, open-label, superiority trial with an adaptive design. Patients with complex CAD and left ventricular ejection fraction ≤40% (n=1,252) deemed at excessive surgical risk for bypass grafting by the Heart Team will be randomised in a 1:1 ratio to PCI with Impella CP versus PCI with or without an IABP. The primary endpoint is the composite of all-cause death, stroke, myocardial infarction, unplanned clinically driven revascularisation, durable left ventricular assist device implant or heart transplant, or other hospitalisation for cardiovascular causes at 3-year follow-up, with at least 1-year follow-up in all patients. Prespecified substudies will evaluate the impact of MCS on renal function, the procedural role of right heart catheterisation, and the utility of myocardial viability assessment. The PROTECT IV trial will determine whether routine MCS with Impella CP during high-risk PCI improves the prognosis of patients with complex CAD and HFrEF.

EuroInterventionVol. 21(21)
Northside Hospital (US), University of Bern (CH), Loma Linda University Medical Center (US), Beth Israel Deaconess Medical Center (US), Yale New Haven Hospital (US), Hackensack University Medical Center (US), Providence College (US), Loma Linda University (US), University Hospital of Bern (CH), Henry Ford Hospital (US), University of California San Diego (US), London School of Hygiene & Tropical Medicine (GB), Cardiovascular Research Foundation (US), Hope Heart Institute (US), Alaska Heart and Vascular Institute (US), Technische Universität Dresden (DE), Icahn School of Medicine at Mount Sinai (US)
Openalex Percentile: Top 4%
Cardiac pacing and defibrillation studies
5.55
DOISourceOpenAlex
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