Controlled Trial of High-risk Coronary Intervention With Percutaneous Left Ventricular Unloading
Overview
- Phase
- Phase 3
- Intervention
- Percutaneous left ventricular unloading
- Conditions
- Ischemic Heart Disease
- Sponsor
- Guy's and St Thomas' NHS Foundation Trust
- Enrollment
- 300
- Locations
- 1
- Primary Endpoint
- Composite hierarchical outcome analysed using a Win Ratio method.
- Status
- Active, Not Recruiting
- Last Updated
- 2 months ago
Overview
Brief Summary
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.
Investigators
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 (Medina 1,1,1 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
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
Arms & Interventions
LV-unloading
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.
Intervention: Percutaneous left ventricular unloading
Standard of Care
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.
Outcomes
Primary Outcomes
Composite hierarchical outcome analysed using a Win Ratio method.
Time Frame: Minimum 12-months of follow-up, up to 51 months
Events included in the composite hierarchical outcome include: death, stroke, spontaneous myocardial infarction, cardiovascular hospitalisation or periprocedural myocardial infarction.
Secondary Outcomes
- Resource utilisation and cost effectiveness measured by quality-adjusted life years (QALYs)(At 12-months post-randomisation)
- Resource utilisation and cost effectiveness measured by incremental costs(At 12-months post-randomisation)
- Resource utilisation and cost effectiveness measured by net monetary benefit(At 12-months post-randomisation)
- Individual components of the primary outcome including: death, stroke, spontaneous myocardial infarction, cardiovascular hospitalisation or periprocedural myocardial injury.(Minimum 12-months of follow-up, up to 51 months)
- Major bleeding using the Bleeding Academic Research Consortium (BARC 3 to 5) classification(At 90 days, 1, 2, 3 and 4 years post-randomisation, up to a maximum of 51 months of follow-up)
- Completeness of revascularisation measured by the change in anatomic BCIS-JS score(Between baseline and the completion of the final planned PCI procedure, up to a maximum of 1 year)
- Completeness of revascularisation measured by the change in anatomic SYNTAX score(Between baseline and the completion of the final planned PCI procedure, up to a maximum of 1 year)
- Vascular complication measured using VARC criteria(Post-procedural at each planned percutaneous coronary intervention procedure, up to a maximum of 1 year)
- Procedural complication measured as the incidence of VT/VF requiring defibrillation, cardiorespiratory arrest, acute pulmonary oedema requiring assisted ventilation or prolonged hypotension(Post-procedural at each planned percutaneous coronary intervention procedure, up to a maximum of 1 year)
- Unplanned revascularisation(At 90 days, 1, 2, 3 and 4 years post-randomisation, up to a maximum of 51 months of follow-up)
- Health-related quality of life and functional status measured by the EuroQol 5-Dimension 5-level questionnaire (EQ-5D- 5L)(At 90 days, 1, 2, 3 and 4 years post-randomisation, up to a maximum of 51 months of follow-up)
- Acute kidney injury(At 90 days post-randomisation)
- Serial cardiac troponin (T or I) levels(At baseline, 6 and 24 hours post-procedure)
- Length of stay(Up to a maximum of 1 year)