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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IABP group | Experimental | Preoperative IABP insertion |
|
| Control group | No Intervention | Preoperative conservative treatment |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Preoperative IABC | Procedure | IABP-Insertion upon inclusion into the trial and admission to the ICU |
|
| Measure | Description | Time Frame |
|---|---|---|
| 30-day all-cause mortality post CABG [%] | 30 days |
| 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 |
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Key inclusion criteria:
Hemodynamically stable high-risk patients before CABG, defined by the following criteria:
Key exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Philippe Grieshaber, MD | Giessen University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Adult and Pediatric Cardiovascular Surgery | Giessen | 35392 | Germany |
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| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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| 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) |
| D007238 |
| Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
| D003327 | Coronary Disease |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |