Coronary Artery Disease, Ischemic Heart Disease
Conditions
Keywords
percutaneous coronary intervention, percutaneous left ventricular unloading
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.
Interventions
DEVICEPercutaneous left ventricular unloading
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.
Sponsors
Guy's and St Thomas' NHS Foundation Trust
London School of Hygiene and Tropical Medicine
The Queen Elizabeth Hospital
The Royal Bournemouth Hospital
St. George's Hospital, London
King's College Hospital NHS Trust
King's College London
Royal Victoria Hospital, Belfast
Bristol Heart Institute
Barts Heart Centre, London
Glenfield Hospital, Leicester
Morriston Hospital, Swansea
St Thomas' Hospital, London
New Cross Hospital, Wolverhampton
Essex Cardiothoracic Centre, Basildon
Freeman Hospital, Newcastle
Golden Jubilee National Hospital, Glasgow
John Radcliffe Hospital, Oxford
Manchester Royal Infirmary
Royal Cornwall Hospital, Truro
Royal Brompton & Harefield NHS Foundation Trust
Musgrove Park Hospital, Taunton
Royal Sussex County Hospital, Brighton
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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 (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 * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Composite hierarchical outcome analysed using a Win Ratio method. | 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | Analysis will include repeated occurrences of these events |
| 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 | — |
| 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 | — |
| 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 | The EuroQol 5-Dimension 5-level questionnaire (EQ-5D- 5L) measures quality of life and functional status with higher scores indicating better outcomes. |
| 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 | — |
| Acute kidney injury | At 90 days post-randomisation | Defined as prolongation hospital admission or readmission ≥ 24 hours with rise in creatinine to 200% of baseline value or need for new renal replacement therapy within 30 days of procedure |
| Serial cardiac troponin (T or I) levels | At baseline, 6 and 24 hours post-procedure | Measured by immunoassay |
| Length of stay | Up to a maximum of 1 year | Measured by the duration of admission in complete days following the index PCI procedure and any subsequent planned staged PCI procedure |
Countries
United Kingdom
Contacts
PRINCIPAL_INVESTIGATORDivaka Perera
KCL, GSTT
Outcome results
None listed