Coronary Artery Disease, Myocardial Infarction
Conditions
Keywords
IABP, IABC, coronary artery disease, prophylactic, cardiac assist
Brief summary
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.
Interventions
PROCEDUREPreoperative IABC
IABP-Insertion upon inclusion into the trial and admission to the ICU
Sponsors
University of Giessen
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 30-day all-cause mortality post CABG [%] | 30 days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 8 days (average) | 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 |
Countries
Germany
Outcome results
None listed