Coronary Artery Disease, Left Ventricular Dysfunction
Conditions
Keywords
Coronary Artery Disease, Percutaneous Transluminal Coronary Angioplasty, Intraaortic Balloon Pumping, Left Ventricular Dysfunction, High Risk
Brief summary
This study will test the hypothesis that elective use of the Intra-Aortic Balloon Pump (IABP) in patients undergoing high-risk Percutaneous Coronary Intervention (PCI) will reduce the rate of in-hospital major adverse cardiac and cerebrovascular events compared to patients who are managed without planned insertion of IABP.
Interventions
Elective IABP insertion before PCI
Sponsors
British Cardiovascular Intervention Society
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
* impaired left ventricular function (Ejection Fraction \< 30%) * large area of myocardium at risk (BCIS-1 Myocardial Jeopardy Score ≥ 8/12)
Exclusion criteria
* cardiogenic shock * acute STEMI within previous 48 hours * complications of recent AMI (including ventricular septal defect, severe mitral regurgitation, intractable ventricular arrhythmias) * contraindications to IABP use (including significant iliac or femoral arterial disease and more than mild aortic regurgitation)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Major Adverse Cardiac and Cerebrovascular Events | Hospital discharge or 28 days following PCI, whichever occurs sooner | (composite endpoint of death, acute myocardial infarction, further revascularization or cerebrovascular event) |
Secondary
| Measure | Time frame |
|---|---|
| Transient Ischemic Attack | Hospital Discharge or 28 days following PCI (whichever occurs sooner) |
| Length of Hospital Stay | Hospital Discharge |
| Procedural Success | Duration of PCI procedure |
| Access Site Complications | Hospital Discharge or 28 days following PCI (whichever occurs sooner) |
| Major Procedural Complications | Duration of PCI procedure |
| Bleeding Complications (Major and Minor) | Hospital Discharge or 28 days following PCI (whichever occurs sooner) |
| All-cause Mortality | 6-months following randomization |
Countries
United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Elective IABP Insertion Left ventricular ejection fraction was 23.6% (SD, 5.2%) in the elective IABP group | 151 |
| No Planned IABP Insertion Left ventricular ejection fraction was 23.6% (SD, 5.5%) in the no planned IABP group | 150 |
| Total | 301 |
Baseline characteristics
| Characteristic | Elective IABP Insertion | No Planned IABP Insertion | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 125 Participants | 117 Participants | 242 Participants |
| Age, Categorical Between 18 and 65 years | 26 Participants | 33 Participants | 59 Participants |
| Sex: Female, Male Female | 29 Participants | 33 Participants | 62 Participants |
| Sex: Female, Male Male | 122 Participants | 117 Participants | 239 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 3 / 151 | 1 / 150 |
| other Total, other adverse events | 2 / 151 | 16 / 150 |
| serious Total, serious adverse events | 2 / 151 | 0 / 150 |
Outcome results
Primary
Major Adverse Cardiac and Cerebrovascular Events
(composite endpoint of death, acute myocardial infarction, further revascularization or cerebrovascular event)
Time frame: Hospital discharge or 28 days following PCI, whichever occurs sooner
Population: All
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Elective IABP Insertion | Major Adverse Cardiac and Cerebrovascular Events | 23 Participants |
| No Planned IABP Insertion | Major Adverse Cardiac and Cerebrovascular Events | 24 Participants |
Secondary
Access Site Complications
Time frame: Hospital Discharge or 28 days following PCI (whichever occurs sooner)
Secondary
All-cause Mortality
Time frame: 6-months following randomization
Secondary
Bleeding Complications (Major and Minor)
Time frame: Hospital Discharge or 28 days following PCI (whichever occurs sooner)
Secondary
Length of Hospital Stay
Time frame: Hospital Discharge
Secondary
Major Procedural Complications
Time frame: Duration of PCI procedure
Secondary
Procedural Success
Time frame: Duration of PCI procedure
Secondary
Transient Ischemic Attack
Time frame: Hospital Discharge or 28 days following PCI (whichever occurs sooner)