Controlled Trial of High-risk Coronary Intervention With Percutaneous Left Ventricular Unloading (CHIP-BCIS3)

Guy's and St Thomas' NHS Foundation Trust

Status and phase: Active, not recruiting; Phase 3

Conditions: Coronary Artery Disease; Ischemic Heart Disease

Treatments: Device: Percutaneous left ventricular unloading

Study type: Interventional

Funder types: Other

Identifiers

NCT05003817

130593 (Other Grant/Funding Number)

17730734 (Registry Identifier)

IRAS290599

Details and patient eligibility

About

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.

Enrollment: 300 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Extensive coronary disease defined by a British Cardiovascular Intervention Society (BCIS) Jeopardy Score ≥ 8*

2. Severe left ventricular systolic dysfunction defined as a LVEF ≤ 35% (or ≤ 45% in the presence of severe mitral regurgitation)#

3. 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 or orbital atherectomy, lithotripsy or laser)

     • in multiple vessels or
     • 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

1. Cardiogenic shock or acute STEMI at randomisation (including current treatment with a mechanical circulatory support device)
2. Contraindication to pLVAD insertion
3. Inability to give informed consent
4. Previously enrolled in CHIP or current enrolment in another interventional study that may affect CHIP outcomes

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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300 participants in 2 patient groups

LV-unloading

Experimental group

Description:

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.

Treatment:

Device: Percutaneous left ventricular unloading

Standard of Care

No Intervention group

Description:

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.