Off-pump Versus On-pump Coronary Artery Bypass Grafting in Frail Patients

Summary

Frailty is defined as a geriatric syndrome of impaired resiliency to stressors (such as cardiac surgery) that has been delineated recently in the cardiovascular literature. One of the most controversial areas of cardiac surgery has been whether off-pump coronary artery bypass grafting (OPCAB) surgery is superior to conventional on-pump coronary artery bypass grafting (CABG) surgery. There is an ongoing debate about the benefits and disadvantages of OPCAB surgery and we believe that this remains an important technique for the improvement of coronary surgery. The benefits of CABG surgery in frail patients are still undetermined. The aim of this study is to clarify the potential benefit of OPCAB surgery in pre-frail and frail patients by comparing off-pump versus on-pump CABG in these patients.

Conditions

• Frail Elderly
• Coronary Artery Disease

Interventions

OTHER

Off-pump coronary-artery bypass grafting

Surgical access to the heart will be gained through a median sternotomy in all of the patients. In order to reduce the risk of bleeding and transfusions, an absorbable hemostat will be used in the sternal bone marrow. An automatic autotransfusion system will be used to recovery of red blood cells in all patients. Off-pump surgery will be performed with the use of heart stabilizers. Patients will be heparinized with 250 IU/kg intravenously to achieve activated clotting time \>200s. The proximal anastomosis will be performed according to our guidelines. The distal anastomosis will be constructed with the help of mechanical stabilizers and cardiac positioner. Intracoronary shunts will be used routinely.

OTHER

On-pump coronary-artery bypass grafting

Surgical access to the heart will be gained through a median sternotomy in all of the patients. On-pump surgery will be performed in normothermia, with the use of aortic cross-clamping and cold cardioplegic arrest. Patients will be heparinized with 500 IU/kg to achieve an activated clotting time \>480 s. Heparin will be neutralized with 1:1 protamine sulfate. The automatic autotransfusion system will be used just in massive blood loss to recovery the red blood cells. Surgical techniques will be performed according to our guidelines.

Sponsors & Collaborators

• Beneficência Portuguesa de São Paulo

  collaborator OTHER

• Instituto Nacional de Cardiologia de Laranjeiras

  collaborator OTHER

• Clinical Hospital Samuel Libânio of Pouso Alegre

  collaborator UNKNOWN

• Hospital do Coração de Messejana Dr. Carlos Alberto Studart

  collaborator UNKNOWN

• University of Sao Paulo General Hospital

  lead OTHER

Principal Investigators

• Omar AV Mejia, MD, PhD · InCor Heart Institute

• Fábio B Jatene, MD, PhD · InCor Heart Institute

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

60 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2019-01-01

Primary Completion

2024-12-31

Completion

2025-12-31

Countries

• United States
• Brazil

Study Locations