Controlled Trial of High-risk Coronary Intervention With Percutaneous Left Ventricular Unloading

Phase 3Active Not RecruitingNCT05003817

Guy's and St Thomas' NHS Foundation Trust300 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

300

Conditions

Ischemic Heart Disease

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Composite hierarchical outcome analysed using a Win Ratio method.

Events included in the composite hierarchical outcome include: death, stroke, spontaneous myocardial infarction, cardiovascular hospitalisation or periprocedural myocardial infarction.

Time frame: Minimum 12-months of follow-up, up to 51 months

Secondary Outcomes

Individual components of the primary outcome including: death, stroke, spontaneous myocardial infarction, cardiovascular hospitalisation or periprocedural myocardial injury.

Analysis will include repeated occurrences of these events

Time frame: Minimum 12-months of follow-up, up to 51 months

Completeness of revascularisation measured by the change in anatomic BCIS-JS score

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: Post-procedural at each planned percutaneous coronary intervention procedure, up to a maximum of 1 year

Unplanned revascularisation

Time frame: 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)

The EuroQol 5-Dimension 5-level questionnaire (EQ-5D- 5L) measures quality of life and functional status with higher scores indicating better outcomes.

Time frame: At 90 days, 1, 2, 3 and 4 years post-randomisation, up to a maximum of 51 months of follow-up

Resource utilisation and cost effectiveness measured by incremental costs

Time frame: At 12-months post-randomisation

Resource utilisation and cost effectiveness measured by quality-adjusted life years (QALYs)

Time frame: At 12-months post-randomisation

Resource utilisation and cost effectiveness measured by net monetary benefit

Time frame: At 12-months post-randomisation

Acute kidney injury

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

Time frame: At 90 days post-randomisation

Serial cardiac troponin (T or I) levels

Measured by immunoassay

Time frame: At baseline, 6 and 24 hours post-procedure

Length of stay

Measured by the duration of admission in complete days following the index PCI procedure and any subsequent planned staged PCI procedure

Time frame: Up to a maximum of 1 year

Controlled Trial of High-risk Coronary Intervention With Percutaneous Left Ventricular Unloading

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes