Prophylactic IABP in High-risk Patients Undergoing CABG

Study Overview
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Brief Summary
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Due to advances and increased practice of interventional therapy for coronary artery disease, the rate of high-risk patients with severe coronary disease and reduced left ventricular function among patients undergoing coronary artery bypass grafting surgery (CABG) is increasing. The perioperative mortality in these patients is ≥ 5%. The perioperative and operative management for these patients has to be optimized in order to reduce their perioperative morbidity and mortality. One of the central aspects is perioperative maintenance of hemodynamic stability. The use of prophylactic IABP is a partly established, but not sufficiently evidence-based measure to reduce ventricular afterload and improve coronary perfusion pre-, intra- and postoperatively. Yet, it is an invasive procedure with potential complications. The planned trial should give an explicit answer, whether preoperative prophylactic IABP decreases 30-day all-cause mortality (primary endpoint) and long-term mortality (3, 6, 12 months; secondary endpoints) compared to preoperative conservative treatment in high-risk patients undergoing CABG.

Official Title
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Prophylactic Preoperative Inatraaortic Balloon Pump (IABP) in High-risk Patients Undergoing Coronary Artery Bypass Surgery (CABG)

Conditions
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Myocardial Infarction, Coronary Artery Disease

Intervention / Treatment
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* Procedure: Preoperative IABC


Participation Criteria
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Eligibility Criteria
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Key inclusion criteria: Hemodynamically stable high-risk patients before CABG, defined by the following criteria: Age >18 years Isolated CABG planned Informed consent in trial participation given Any left ventricular functional impairment (regional wall motion abnormality or global LVEF<55%) assessed via ventriculography or transthoracic or transeophageal echocardiography Elevated cardiac biomarkers (CK-MB > 6% of total-CK, Troponin I > 3-fold of specific test reference) or myocardial infarction (NSTEMI or STEMI) within the last 4 days. Key exclusion criteria: Contraindications for IABP Cardiogenic shock Shock of any other cause Critical preoperative state according to EuroSCORE II-criteria Cardiac surgical procedure other than CABG planned Severe comorbidity with life expectancy < 6 months Incapability of giving informed consent

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IABP group<br>Preoperative IABP insertion | Procedure: Preoperative IABC<br>* IABP-Insertion upon inclusion into the trial and admission to the ICU<br>|
| No Intervention: Control group<br>Preoperative conservative treatment | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 30-day all-cause mortality post CABG [%] |  | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival at 3, 6, 12 months [%] |  | 3, 6 and 12 months | 
| Duration of ICU stay [h] |  | 48 hours (average) | 
| Dependence on medical inotropic support |  | 48 hours (average) | 
| IABP-associated complications | IABP-associated complications occur most often during IABP-support. However, after weaning from IABP, patients can still have bleeding complications or thrombembolic complications. Therefore, IABP-associated complications are monitored during the whole hospital stay | 8 days (average) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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IABP, IABC, coronary artery disease, prophylactic, cardiac assist