Controlled Trial of High-risk Coronary Intervention With Percutaneous Left Ventricular Unloading

Study Overview
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Brief Summary
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Over 100,000 coronary stent procedures, where small balloons are used to stretch open a narrowed blood vessel, are performed every year in the United Kingdom to treat people who have conditions such as angina or have suffered a heart attack. For most patients the risk of complications is low, but for some, there is a higher risk of their heart failing during the procedure. Heart failure is a serious complication which can need treatment with a life support machine and lead to major damage to the heart muscle or even death. These risks are greatest in patients with severely diseased heart arteries and those who already have weakened heart muscle. A new technology may be able to help with this problem. It consists of a small heart pump which is placed in the heart's main pumping chamber (the left ventricle, LV). This pump is known as a LV unloading device. The LV unloading device is inserted into the heart through a blood vessel in the leg and supports the heart muscle. It is removed at the end of the procedure or when the heart can pump safely on its own. Whilst this heart pump is promising, it comes with some risks of its own. These include bleeding and damage to the arteries in the legs. It is also expensive, costing £8,000 per operation. Currently, there is no strong evidence to guide the use of this device. The CHIP-BCIS3 study aims to determine whether these heart pumps are beneficial and cost-effective in patients receiving a stenting procedure who are at high-risk of complications.

Official Title
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Controlled Trial of High-risk Coronary Intervention With Percutaneous Left Ventricular Unloading

Conditions
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Ischemic Heart Disease, Coronary Artery Disease

Intervention / Treatment
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* Device: Percutaneous left ventricular unloading


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Extensive coronary disease defined by a British Cardiovascular Intervention Society (BCIS) Jeopardy Score ≥ 8* Severe left ventricular systolic dysfunction defined as a LVEF ≤ 35% (or ≤ 45% in the presence of severe mitral regurgitation)# Complex PCI defined by the presence of at least one of the following criteria: Unprotected left main intervention in the presence of an occluded dominant right coronary artery, or a left dominant circulation, or disease involving the entire bifurcation (Medina1,1,1 or 0,1,1) Intended calcium modification (by rotational atherectomy, lithotripsy or laser) o inmultiplevesselsor in the left main stem, or in a final patent conduit, or where the anatomic SYNTAX score is ≥32 Target vessel is a chronic total occlusion with planned retrograde approach * In general, patients who do not have bypass grafts will be eligible if the patient has at least proximal left anterior descending (LAD) disease or at least proximal 2 vessel disease. For patients with patent bypass grafts, or in cases where the extent of coronary artery disease (CAD) is uncertain, the BCIS-1 JS should be calculated. The maximum possible JS score is 12. N.B. The JS should be based on all coronary disease, not just the vessel subtending viable myocardium. Biplane / 3D echocardiography, or cardiac MRI can be used to assess the qualifying LVEF. Exclusion Criteria: Cardiogenic shock or acute STEMI at randomisation (including current treatment with a mechanical circulatory support device) Contraindication to pLVAD insertion Inability to give informed consent Previously enrolled in CHIP or current enrolment in another interventional study that may affect CHIP outcomes

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LV-unloading<br>Participants in the elective unloading (intervention) group will have a percutaneous left ventricular unloading device (pLVAD) inserted at the start of the procedure, before the coronary intervention. Maximal support will be provided throughout the procedure, following which support will be weaned and the device removed should the patient remain haemodynamically stable. | Device: Percutaneous left ventricular unloading<br>* Percutaneous left ventricular unloading involves the placement of a mechanical pump which draws blood from the left ventricle and returns it into the aorta at flow rates approaching native cardiac output.<br>|
| No Intervention: Standard of Care<br>Participants in the control arm will receive the planned high-risk percutaneous coronary intervention as is the current standard of care without elective left ventricular unloading. Alternative mechanical circulatory support devices (such as the intra-aortic balloon pump (IABP) or extracorporeal membrane oxygenation (ECMO) will only be permitted in case of complications. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite hierarchical outcome analysed using a Win Ratio method. | Events included in the composite hierarchical outcome include: death, stroke, spontaneous myocardial infarction, cardiovascular hospitalisation or periprocedural myocardial infarction. | Minimum 12-months of follow-up, up to 4 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Individual components of the primary outcome including: death, stroke, spontaneous myocardial infarction, cardiovascular hospitalisation or periprocedural myocardial infarction. | Analysis will include repeated occurrences of these events | Minimum 12-months of follow-up, up to 4 years | 
| Completeness of revascularisation measured by the change in anatomic BCIS-JS score |  | Between baseline and the completion of the final planned PCI procedure assessed up to 90 days post-randomisation | 
| Completeness of revascularisation measured by the change in anatomic SYNTAX score |  | Between baseline and the completion of the final planned PCI procedure assessed up to 90 days post-randomisation | 
| Major bleeding (BARC 3 or 5) using the Bleeding Academic Research Consortium (BARC) classification |  | Up to 90 days post-randomisation | 
| Vascular complication measured as the incidence of injury to a major artery or vein resulting in either major bleeding, tissue ischaemia/necrosis requiring percutaneous or surgical intervention, or death |  | At discharge from each planned percutaneous coronary intervention procedure up to 90 days post-randomisation | 
| Procedural complication measured as the incidence of VT/VF requiring defibrillation, cardiorespiratory arrest, acute pulmonary oedema requiring assisted ventilation or prolonged hypotension |  | At discharge from each planned percutaneous coronary intervention procedure up to 90 days post-randomisation | 
| Unplanned revascularisation |  | Up to 90 days post-randomisation | 
| Health-related quality of life and functional status measured by the EuroQol 5-Dimension 5-level questionnaire (EQ-5D- 5L) | The EuroQol 5-Dimension 5-level questionnaire (EQ-5D- 5L) measures quality of life and functional status with higher scores indicating better outcomes. | 90 days and 1 year post-randomisation | 
| Resource utilisation and cost effectiveness measured by incremental costs |  | At 12-months post-randomisation | 
| Resource utilisation and cost effectiveness measured by quality-adjusted life years (QALYs) |  | At 12-months post-randomisation | 
| Resource utilisation and cost effectiveness measured by net monetary benefit |  | At 12-months post-randomisation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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percutaneous coronary intervention, percutaneous left ventricular unloading