Arrested Versus Beating Heart Techniques in Coronary Revascularisation

Martin-Luther-Universität Halle-Wittenberg

Status and phase: Unknown; Phase 3

Conditions: Coronary Artery Bypass Grafting

Treatments: Procedure: Conventional Coronary Artery Bypass; Procedure: Pump-Assisted Coronary Artery Bypass; Procedure: Off-Pump Coronary Artery Bypass

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00999089

3CAB-STUDY

Details and patient eligibility

About

The individual contribution of the specific injuring mechanisms surgical trauma, extracorporeal circulation, and ischemia/reperfusion to clinical outcome in coronary revascularisation remains to be elucidated. The effect of these factors is analyzed in this randomized clinical trial by comparing the 3 surgical approaches: Conventional Coronary Artery Bypass Grafting (CCAB), with extracorporeal circulation and cardioplegic arrest; Off-Pump Coronary Artery Bypass Grafting (OPCAB), avoids extracorporeal circulation and global myocardial ischemia; and Pump-Assisted Coronary Artery Bypass Grafting (PACAB), with an unloaded and beating heart. The hypothesis addressed by the study is that the surgical invasiveness increases in the order: OPCAB, PACAB, CCAB.

Enrollment: 616 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• patients with double- or triple-vessel coronary artery disease
• patients with left ventricular ejection fraction =< 40% or >= 60%
• elective or urgent isolated coronary artery bypass grafting

Exclusion criteria

• previous cardiac surgery
• emergency indications

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

616 participants in 3 patient groups

CCAB

Active Comparator group

Description:

Conventional Coronary Artery Bypass

Treatment:

Procedure: Conventional Coronary Artery Bypass

OPCAB

Active Comparator group

Description:

Off-Pump Coronary Artery Bypass

Treatment:

Procedure: Off-Pump Coronary Artery Bypass

PACAB

Active Comparator group

Description:

Pump-Assisted Coronary Artery Bypass

Treatment:

Procedure: Pump-Assisted Coronary Artery Bypass