Ischaemic heart failure Circulatory System Ischaemic cardiomyopathy
Conditions
Interventions
Participants will be randomized on a 1:1 basis prior to the PCI procedure using an electronic randomisation service.
Participants in the elective unloading (intervention) group will have a percutaneo
Sponsors
King's College London
Guy’s and St Thomas’s NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
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 an 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: 3.1. Unprotected left main intervention in the presence of 3.1.1. An occluded dominant right coronary artery or 3.1.2. A left dominant circulation or 3.1.3. Disease involving the entire bifurcation (Medina 1,1,1 or 0,1,1) 4. Intended calcium modification (by rotational atherectomy, lithotripsy or laser) 4.1. In multiple vessels or 4.2. In the left mainstem or 4.3. In a final patent conduit or 4.4. Where the anatomic SYNTAX score is =32 5. Target vessel is a chronic total occlusion with a planned retrograde approach
Exclusion criteria
Exclusion criteria: Current exclusion criteria as of 23/02/2023: 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 _____ Previous exclusion criteria: 1. Cardiogenic shock or acute STEMI at randomization 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 |
|---|---|
| Current primary outcome measures as of 29/10/2025: Composite hierarchical outcome of death, stroke, spontaneous myocardial infarction, cardiovascular hospitalisation (including prolongation of the index admission for bleeding and vascular complications) and periprocedural myocardial infarction analysed using a Win Ratio method between 12 and 51 months. Previous primary outcome measures: Composite hierarchical outcome of death, stroke, spontaneous myocardial infarction, cardiovascular hospitalisation (including prolongation of the index admission for bleeding and vascular complications) and periprocedural myocardial infarction analysed using a Win Ratio method between 1 and 4 years. | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 05/02/2026: 1. Individual components of the primary outcome (as well as repeated occurrences of these events) between 12 and 51 months (including all-cause death, cardiovascular death, disabling stroke, spontaneous myocardial infarction, cardiovascular hospitalisation, periprocedural myocardial injury) 2. Completeness of revascularisation measured by the change in anatomic BCIS-JS and anatomic SYNTAX score between baseline and the completion of the final planned PCI procedure 3. Major bleeding defined using Bleeding Academic Research Consortium (BARC 3 to 5) classification at each timepoint post-randomisation 4. Vascular complication measured using VARC criteria at discharge from each planned PCI procedure 5. 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 PCI procedure 6. Unplanned revascularisation at each timepoint post-randomisation 7. Health-related quality of life/functional status measured by the EuroQol 5-Dimension 5-level questionnaire (EQ-5D- 5L) at 90 days, 1 year and annually post-randomisation 8. Resource utilisation and cost effectiveness measured by incremental costs, quality-adjusted life years (QALYs) and net monetary benefit at 12 months 9. 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. 10. Serial cardiac troponin (T or I) levels measured by immunoassay at baseline, 6 and 24 hours post-procedure 11. Length of stay measured by the duration of complete days following the index PCI procedure and any subsequent planned staged PCI procedure Previous secondary outcome measures as of 29/10/2025: 1. Individual components of the primary outcome (as well as | — |
Countries
England, United Kingdom
Contacts
Public ContactMatt Kwok
Outcome results
None listed