Evidence of the Advantages of Preoperative Intra-aortic Balloon Pump in Surgical Revascularization of Acute Myocardial Infarction
| Registry | NCT06468982 |
|---|---|
| Status | Completed |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: none, treatment |
| Enrollment | 156 (Actual) |
| Sponsor | Ataturk University (Other) |
| Conditions | Acute Myocardial Infarction, Coronary Artery Disease, Coronary Bypass Graft Stenosis of Autologous Vessel, Troponin, IABP - Disorder of Intra-Aortic Balloon Pump |
| Interventions | Intra-aortic Balloon Pump (Device) |
| Dates | start 2021-05-01, primary completion 2023-12-31, completion 2023-12-31, first posted 2024-06-21, last updated 2025-02-27 |
| Locations | 2 sites in Turkey (Türkiye) |
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All trials for Acute Myocardial Infarction All trials for Coronary Artery Disease All trials of Intra-aortic Balloon Pump
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).
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Group A (IABP support) | Active comparator | Device: Intra-aortic Balloon Pump | Patients who are receiving intra-aortic balloon pump support during the preoperative period |
| Group B (control group; without IABP support) | No intervention | Patients who did not receive intra-aortic balloon pump support in the preoperative period; control group |
Sex: All, ages: 18 Years to 85 Years
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
| Milestone | Group A (IABP Support) | Group B (Control Group; Without IABP Support) |
|---|---|---|
| Started | 64 | 92 |
| Completed | 64 | 92 |
| Not completed | 0 | 0 |
Time frame: Adverse events were recorded during the period from the 1st to the 30th postoperative day for each patient who underwent coronary artery bypass grafting surgery
| Arm | Deaths | Serious adverse events | Other adverse events |
|---|---|---|---|
| Group A (IABP Support) | 4/64 (6.3%) | 12/64 (18.8%) | 12/64 (18.8%) |
| Group B (Control Group; Without IABP Support) | 7/92 (7.6%) | 13/92 (14.1%) | 16/92 (17.4%) |
| Term | Organ system | Group A (IABP Support) | Group B (Control Group; Without IABP Support) |
|---|---|---|---|
| low cardiac output syndrome | Cardiac disorders | 2/64 | 5/92 |
| Neurological complications | Nervous system disorders | 1/64 | 4/92 |
| Surgical revision for bleeding | Blood and lymphatic system disorders | 9/64 | 4/92 |
| Term | Organ system | Group A (IABP Support) | Group B (Control Group; Without IABP Support) |
|---|---|---|---|
| Atrial fibrillation | Cardiac disorders | 12/64 | 16/92 |
Limitations and caveats: Not using more than one troponin test kit. The Swan-Ganz catheter or cardiac index device cannot be used in every patient.
| Facility | City | Country | Status |
|---|---|---|---|
| Atatürk University | Yakutiye, Erzurum | Turkey (Türkiye) | |
| Atatürk University | Erzurum | Turkey (Türkiye) |