Acute Myocardial Infarction, Coronary Artery Disease, Coronary Bypass Graft Stenosis of Autologous Vessel, IABP - Disorder of Intra-Aortic Balloon Pump, Troponin
Conditions
Keywords
Acute myocardial infarction, coronary artery bypass surgery, intra-aortic balloon pump, high-sensitivity cardiac troponin I
Brief summary
The optimal timing of surgery in patients with acute myocardial infarction (AMI) and the utilization of preoperative intra-aortic balloon pumps (IABP) in these patients are subjects of ongoing discussion and disagreement. This study aimed to investigate the effects of preoperative IABP on troponin levels, surgical timing, and intraoperative and postoperative outcomes for patients with AMI who undergo coronary artery bypass grafting (CABG).
Detailed description
Percutaneous coronary intervention (PCI) is the first treatment for myocardial ischemia; however, if left main coronary artery disease, multivessel disease, or complex architecture disable PCI, 10% of patients may need coronary artery bypass grafting (CABG). Abstinence from surgical reperfusion in patients with acute myocardial infarction (AMI) may be justified due to surgery's 50% mortality rate. An intra-aortic balloon pump (IABP) can help patients who have ongoing ischemia and high cardiac enzymes because it changes the way the heart uses oxygen by increasing coronary blood flow and lowering afterload. Some guidelines do not recommend the use of IABP in patients with AMI except for mechanical complications or shock. Nevertheless, it is commonly acknowledged that the specific criteria for employing IABP differ among clinics and are determined by clinical expertise. Patients with AMI who have impaired coronary perfusion and require surgical revascularization can benefit from preoperative intra-aortic balloon pump (IABP) support. This intervention leads to reorganization of coronary perfusion, resulting in a decrease in elevated troponin levels and quicker myocardial recovery.
Interventions
It will be applied to patients with acute myocardial infarction who have elevated troponin levels and recurrent or persistent chest pain at rest, hemodynamic instability, multivascular disease, left main coronary artery disease, and patients with narrow and/or tortuous coronary artery anatomy in whom PCI has failed or is not applicable.
Sponsors
Ataturk University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
two groups for patients with acute myocardial infarction scheduled for coronary artery bypass Grafting: Group A with IABP support, and Group B (the control group) without IABP
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Patients who have had acute myocardial infarction and have been decided on coronary surgical revascularization
Exclusion criteria
* mechanical complications of Acute Myocardial Infarction (such as a ruptured chordal or ventricular septum) * peripheral arterial disease * renal failure * history of cerebrovascular accident * acute cardiogenic shock and cardiac arrest * reoperation and combined operations
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| High-Sensitivity Cardiac Troponin Levels From Days 0-7 | 0-7 days | Daily repeated measurements of high-sensitivity cardiac troponin (hs-cTnI) on the ng/mL scale were compared between the two groups. The study hypothesizes that hs-cTnI levels decrease more rapidly in participants receiving IABP support compared to those without IABP. This decrease is posited to reflect a myocardial healing process. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| In-hospital Mortality | 0-30 days | Deaths occurring in the first 30 days after the operation have been defined as mortality. |
Countries
Turkey (Türkiye)
Participant flow
Recruitment details
Participants were selected based on their participation in a single center's cardiovascular surgery and cardiology council from May 2021 to December 2023. The first participant was enrolled on May 1, 2021 and the last participant was enrolled on December 31,2023.
Participants by arm
| Arm | Count |
|---|---|
| Group A (IABP Support) Patients who are receiving intra-aortic balloon pump support during the preoperative period
Intra-aortic Balloon Pump: in patients with acute myocardial infarction involving elevated troponin levels and recurrent or persistent chest pain at rest, hemodynamic instability, multivessel disease, left main coronary artery disease, and narrow and/or tortuous coronary artery anatomy in which PCI has failed or is not feasible. | 64 |
| Group B (Control Group; Without IABP Support) Patients who did not receive intra-aortic balloon pump support in the preoperative period; control group | 92 |
| Total | 156 |
Baseline characteristics
| Characteristic | Group A (IABP Support) | Total | Group B (Control Group; Without IABP Support) |
|---|---|---|---|
| Age, Continuous | 63.1 years STANDARD_DEVIATION 8.9 | 64.6 years STANDARD_DEVIATION 8.3 | 65.2 years STANDARD_DEVIATION 8.1 |
| Chest pain score | 7.6 scores on a scale STANDARD_DEVIATION 1.8 | 5.1 scores on a scale STANDARD_DEVIATION 3.2 | 2.3 scores on a scale STANDARD_DEVIATION 1.4 |
| C-reactive protein levels | 23.4 mg/L (0-5) STANDARD_DEVIATION 19.8 | 22.2 mg/L (0-5) STANDARD_DEVIATION 17.3 | 21.7 mg/L (0-5) STANDARD_DEVIATION 16.4 |
| EuroScore II | 2.2 Percentage of risk (%) STANDARD_DEVIATION 1.4 | 2.1 Percentage of risk (%) STANDARD_DEVIATION 1.2 | 2 Percentage of risk (%) STANDARD_DEVIATION 1.2 |
| High sensitive cardiac troponin-I levels | 29.2 ng/mL STANDARD_DEVIATION 20.5 | 20.4 ng/mL STANDARD_DEVIATION 18.3 | 17.3 ng/mL STANDARD_DEVIATION 16.6 |
| Left ventricular ejection fraction | 44.9 percentage of ejected blood (50-65%) STANDARD_DEVIATION 7.7 | 47.1 percentage of ejected blood (50-65%) STANDARD_DEVIATION 7.3 | 47.9 percentage of ejected blood (50-65%) STANDARD_DEVIATION 7 |
| Percentage of glycated hemoglobin (HbA1c) | 7.4 percentage of glycated hemoglobin STANDARD_DEVIATION 2.3 | 6.8 percentage of glycated hemoglobin STANDARD_DEVIATION 2.1 | 6.7 percentage of glycated hemoglobin STANDARD_DEVIATION 1.9 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 64 Participants | 156 Participants | 92 Participants |
| Sex: Female, Male Female | 17 Participants | 84 Participants | 67 Participants |
| Sex: Female, Male Male | 47 Participants | 72 Participants | 25 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 4 / 64 | 7 / 92 |
| other Total, other adverse events | 12 / 64 | 16 / 92 |
| serious Total, serious adverse events | 12 / 64 | 13 / 92 |
Outcome results
Primary
High-Sensitivity Cardiac Troponin Levels From Days 0-7
Daily repeated measurements of high-sensitivity cardiac troponin (hs-cTnI) on the ng/mL scale were compared between the two groups. The study hypothesizes that hs-cTnI levels decrease more rapidly in participants receiving IABP support compared to those without IABP. This decrease is posited to reflect a myocardial healing process.
Time frame: 0-7 days
Population: Daily troponin results were recorded for both groups
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group A (IABP Support) | High-Sensitivity Cardiac Troponin Levels From Days 0-7 | 0.days | 29.2 ng/mL (0-0.04) | Standard Deviation 20.5 |
| Group A (IABP Support) | High-Sensitivity Cardiac Troponin Levels From Days 0-7 | 1.days | 23.2 ng/mL (0-0.04) | Standard Deviation 17.7 |
| Group A (IABP Support) | High-Sensitivity Cardiac Troponin Levels From Days 0-7 | 2.days | 15.8 ng/mL (0-0.04) | Standard Deviation 13.2 |
| Group A (IABP Support) | High-Sensitivity Cardiac Troponin Levels From Days 0-7 | 3.days | 9.9 ng/mL (0-0.04) | Standard Deviation 9.3 |
| Group A (IABP Support) | High-Sensitivity Cardiac Troponin Levels From Days 0-7 | 4.days | 5.9 ng/mL (0-0.04) | Standard Deviation 6.2 |
| Group A (IABP Support) | High-Sensitivity Cardiac Troponin Levels From Days 0-7 | 5.days | 4.4 ng/mL (0-0.04) | Standard Deviation 4.5 |
| Group A (IABP Support) | High-Sensitivity Cardiac Troponin Levels From Days 0-7 | 6.days | 2.3 ng/mL (0-0.04) | Standard Deviation 2.2 |
| Group A (IABP Support) | High-Sensitivity Cardiac Troponin Levels From Days 0-7 | 7.days | 1.5 ng/mL (0-0.04) | Standard Deviation 1.7 |
| Group B (Control Group; Without IABP Support) | High-Sensitivity Cardiac Troponin Levels From Days 0-7 | 7.days | 4.2 ng/mL (0-0.04) | Standard Deviation 5.6 |
| Group B (Control Group; Without IABP Support) | High-Sensitivity Cardiac Troponin Levels From Days 0-7 | 0.days | 17.3 ng/mL (0-0.04) | Standard Deviation 16.6 |
| Group B (Control Group; Without IABP Support) | High-Sensitivity Cardiac Troponin Levels From Days 0-7 | 4.days | 9.5 ng/mL (0-0.04) | Standard Deviation 12.8 |
| Group B (Control Group; Without IABP Support) | High-Sensitivity Cardiac Troponin Levels From Days 0-7 | 1.days | 16.7 ng/mL (0-0.04) | Standard Deviation 16.3 |
| Group B (Control Group; Without IABP Support) | High-Sensitivity Cardiac Troponin Levels From Days 0-7 | 6.days | 5.3 ng/mL (0-0.04) | Standard Deviation 7.5 |
| Group B (Control Group; Without IABP Support) | High-Sensitivity Cardiac Troponin Levels From Days 0-7 | 2.days | 14.9 ng/mL (0-0.04) | Standard Deviation 14.8 |
| Group B (Control Group; Without IABP Support) | High-Sensitivity Cardiac Troponin Levels From Days 0-7 | 5.days | 6.9 ng/mL (0-0.04) | Standard Deviation 10 |
| Group B (Control Group; Without IABP Support) | High-Sensitivity Cardiac Troponin Levels From Days 0-7 | 3.days | 12.3 ng/mL (0-0.04) | Standard Deviation 12.6 |
Comparison: After testing for normality, the baseline characteristics of the two groups will be analyzed using the Student's t-test or the Mann-Whitney U-test for continuous variables and the chi-square test or Fisher's exact test for categorical variables. Differences between the intra-aortic balloon pump group and the control group in terms of repeated measurements will be analyzed using mixed ANOVA.p-value: 0.05ANOVA
Secondary
In-hospital Mortality
Deaths occurring in the first 30 days after the operation have been defined as mortality.
Time frame: 0-30 days
Population: The analysis includes patients with acute myocardial infarction undergoing coronary artery bypass grafting (CABG) and follows mortality 0-30 days postoperatively, defined as in-hospital death.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group A (IABP Support) | In-hospital Mortality | 4 Participants |
| Group B (Control Group; Without IABP Support) | In-hospital Mortality | 7 Participants |
Comparison: The prognostic value of risk factors for in-hospital mortality was evaluated by multivariate logistic regression analysisp-value: <0.0595% CI: [0.38, 0.78]Wilcoxon (Mann-Whitney)