Controlled Trial of High-risk Coronary Intervention With Percutaneous Left Ventricular Unloading (CHIP-BCIS3)
Ischemic Heart Disease, Coronary Artery Disease
About this trial
This is an interventional treatment trial for Ischemic Heart Disease focused on measuring percutaneous coronary intervention, percutaneous left ventricular unloading
Eligibility Criteria
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
- 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
Sites / Locations
- Guy's and St Thomas' NHS Foundation TrustRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
No Intervention
LV-unloading
Standard of Care
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.
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.