Prophylactic IABP in High-risk Patients Undergoing CABG

University of Giessen

Status: Withdrawn

Conditions: Coronary Artery Disease; Myocardial Infarction

Treatments: Procedure: Preoperative IABC

Study type: Interventional

Funder types: Other

Identifiers

NCT01950130

A-1124

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

0 participants in 2 patient groups

IABP group

Experimental group

Description:

Preoperative IABP insertion

Treatment:

Procedure: Preoperative IABC

Control group

No Intervention group

Description:

Preoperative conservative treatment