Mechanical circulatory support in high-risk elective percutaneous coronary intervention (PCI): rationale and design of the PROTECT IV trial
Study context
- Population
- Patients with complex coronary artery disease (CAD) and left ventricular ejection fraction ≤40% deemed at excessive surgical risk for bypass grafting by the Heart Teamplanned enrolment
- Participants
- 1,252 patients
- Planned comparison
- PCI with Impella CP versus PCI with or without an intra-aortic balloon pump (IABP)
- Primary endpoint
- Composite of:
- All-cause death
- Stroke
- Myocardial infarction
- Unplanned clinically driven revascularisation
- Durable left ventricular assist device implant or heart transplant
- Other hospitalisation for cardiovascular causes
- Follow-up
- 3-year , with at least 1-year in all patients
No results yet. This paper sets out the design of a trial; its results are to come.
Further findings
Prespecified substudies
- Impact of mechanical circulatory support (MCS) on renal function, the procedural role of right heart catheterisation, and the utility of myocardial viability assessment
Original publication
Mechanical circulatory support in high-risk elective PCI: rationale and design of the PROTECT IV trial. EuroIntervention. Published 30 September 2025. doi:10.
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