Clinical trial NCT05003817: Controlled Trial of High-risk Coronary Intervention With Percutaneous Left Ventricular Unloading
Official title: Controlled Trial of High-risk Coronary Intervention With Percutaneous Left Ventricular Unloading
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Ischemic Heart Disease
Coronary Artery Disease
Keywords: percutaneous coronary intervention
percutaneous left ventricular unloading
Lead sponsor: Guy's and St Thomas' NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: London School of Hygiene and Tropical Medicine
name: The Queen Elizabeth Hospital
name: The Royal Bournemouth Hospital
name: St. George's Hospital, London
name: King's College Hospital NHS Trust
name: King's College London
name: Royal Victoria Hospital, Belfast
name: Bristol Heart Institute
name: Barts Heart Centre, London
name: Glenfield Hospital, Leicester
name: Morriston Hospital, Swansea
name: St Thomas' Hospital, London
name: Royal Sussex County Hospital
name: New Cross Hospital, Wolverhampton
name: Essex Cardiothoracic Centre, Basildon
name: Freeman Hospital, Newcastle
name: Golden Jubilee National Hospital, Glasgow
name: John Radcliffe Hospital, Oxford
name: Manchester Royal Infirmary
name: Musgrove Park Hospital, Taunton
name: Royal Brompton Hospital, London
name: Royal Cornwall Hospital, Truro
First posted: 2021-08-12
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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 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 (Medina1,1,1 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

Primary outcomes:
measure: Composite hierarchical outcome analysed using a Win Ratio method.
timeFrame: Minimum 12-months of follow-up, up to 4 years
Secondary outcomes:
measure: Individual components of the primary outcome including: death, stroke, spontaneous myocardial infarction, cardiovascular hospitalisation or periprocedural myocardial infarction.
timeFrame: Minimum 12-months of follow-up, up to 4 years
measure: Completeness of revascularisation measured by the change in anatomic BCIS-JS score
timeFrame: Between baseline and the completion of the final planned PCI procedure assessed up to 90 days post-randomisation
measure: Completeness of revascularisation measured by the change in anatomic SYNTAX score
timeFrame: Between baseline and the completion of the final planned PCI procedure assessed up to 90 days post-randomisation
measure: Major bleeding (BARC 3 or 5) using the Bleeding Academic Research Consortium (BARC) classification
timeFrame: Up to 90 days post-randomisation
measure: Vascular complication measured as the incidence of injury to a major artery or vein resulting in either major bleeding, tissue ischaemia/necrosis requiring percutaneous or surgical intervention, or death
timeFrame: At discharge from each planned percutaneous coronary intervention procedure up to 90 days post-randomisation
measure: Procedural complication measured as the incidence of VT/VF requiring defibrillation, cardiorespiratory arrest, acute pulmonary oedema requiring assisted ventilation or prolonged hypotension
timeFrame: At discharge from each planned percutaneous coronary intervention procedure up to 90 days post-randomisation
measure: Unplanned revascularisation
timeFrame: Up to 90 days post-randomisation
measure: Health-related quality of life and functional status measured by the EuroQol 5-Dimension 5-level questionnaire (EQ-5D- 5L)
timeFrame: 90 days and 1 year post-randomisation
measure: Resource utilisation and cost effectiveness measured by incremental costs
timeFrame: At 12-months post-randomisation
measure: Resource utilisation and cost effectiveness measured by quality-adjusted life years (QALYs)
timeFrame: At 12-months post-randomisation
measure: Resource utilisation and cost effectiveness measured by net monetary benefit
timeFrame: At 12-months post-randomisation
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Guy's and St Thomas' NHS Foundation Trust
Study officials:
affiliation: KCL, GSTT
name: Divaka Perera
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ryan M, Ezad SM, Webb I, O'Kane PD, Dodd M, Evans R, Laidlaw L, Khan SQ, Weerackody R, Bagnall A, Panoulas VF, Rahman H, Strange JW, Fath-Ordoubadi F, Hoole SP, Stables RH, Curzen N, Clayton T, Perera D; CHIP-BCIS3 Investigators. Percutaneous Left Ventricular Unloading During High-Risk Coronary Intervention: Rationale and Design of the CHIP-BCIS3 Randomized Controlled Trial. Circ Cardiovasc Interv. 2024 Mar;17(3):e013367. doi: 10.1161/CIRCINTERVENTIONS.123.013367. Epub 2024 Feb 27.