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

NCT02338947 | Active Not Recruiting DMC

• 2 other identifiers: USaoPauloGH1000Sao Paulo Research Foundation
• Study Type: interventional
• Target: 440
• Locations: 2 countries
• Sites: 7

Brief 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

Keywords

Frail elderly; Coronary artery bypass surgery; Off-pump; On-pump; Randomized controlled trial

Outcome Measures

Primary Outcomes (1)

• Major adverse cardiac and cerebrovascular events after OPCAB and CABG in pre-frail and frail patients

  This composite outcome comprises: all cause death, acute myocardial infarction, stroke, renal failure, acute respiratory distress syndrome and bleeding reoperation

  From the date of surgery until 30 days postoperatively, assessed up to 30 days

Secondary Outcomes (13)

• Operative time

  From the start of anesthesia induction to the end of the surgical procedure

• Mechanical ventilation time

  From the initiation of mechanical ventilation in the operating room or ICU to the time of successful extubation

• Hyperdynamic shock

  From the date of surgery until 30 days postoperatively, assessed up to 30 days

• New onset of atrial fibrillation

  From the date of surgery until 30 days postoperatively, assessed up to 30 days

• Need for pacing >24 hours

  From the date of surgery until 30 days postoperatively, assessed up to 30 days

Other Outcomes (7)

• Delirium

  From the date of surgery until 30 days postoperatively, assessed up to 30 days

• Neurobehavioral outcomes after cardiac surgery

  From the date of hospital discharge until 6 months postoperatively and from the date of hospital discharge until 12 months postoperatively, assessed up to 1 year

• Quality of life after cardiac surgery

  From the date of hospital discharge until 6 months postoperatively and from the date of hospital discharge until 12 months postoperatively, assessed up to 1 year

Study Arms (2)

Off-pump coronary-artery bypass grafting - OPCAB

ACTIVE COMPARATOR

Pre-frail and frail patients will be randomly assigned to OPCAB after the evaluation of the target vessels by an internet-based, password protected database program. The surgery will be performed as described in the "intervention" section and the patients will be followed up for two years.

Other: Off-pump coronary-artery bypass grafting

On-pump coronary-artery bypass grafting - CABG

ACTIVE COMPARATOR

Pre-frail and frail patients will be randomly assigned to CABG after the evaluation of the target vessels by an internet-based, password protected database program. The surgery will be performed as described in the "intervention" section and the patients will be followed up for two years.

Other: On-pump coronary-artery bypass grafting

Interventions

Off-pump coronary-artery bypass grafting OTHER

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.

Also known as: OPCAB

Off-pump coronary-artery bypass grafting - OPCAB

On-pump coronary-artery bypass grafting OTHER

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.

Also known as: CABG

On-pump coronary-artery bypass grafting - CABG

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- Participants aged ≥60 years with the indication of myocardial revascularization with ≥2 criteria of frailty by Fried Frailty Criteria, and suitable to undergo either Off-pump or On-pump CABG.

You may not qualify if:

• \- Patients with the indication of angioplasty or another procedure in addition to CABG; patients who underwent an emergency operation (within 24 hours after hospital admission); patients who underwent previous cardiac surgery, even with other approaches than median sternotomy; patients who do not have free, prior and informed consent to participate in this study.

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead
• Beneficência Portuguesa de São Paulo: collaborator
• Instituto Nacional de Cardiologia de Laranjeiras: collaborator
• Clinical Hospital Samuel Libânio of Pouso Alegre: collaborator
• Hospital do Coração de Messejana Dr. Carlos Alberto Studart: collaborator

Study Sites (7)

Emory University School of Medicine

Atlanta, Georgia, 30322, United States

Location

Hospital de Messejana

Fortaleza, Ceará, Brazil

Location

Hospital das Clínicas Samuel Libânio

Pouso Alegre, Minas Gerais, 37550-000, Brazil

Location

Hospital Alberto Urquiza Wanderley

João Pessoa, Paraíba, 58040-300, Brazil

Location

Instituto Nacional de Cardiologia de Laranjeiras

Rio de Janeiro, Rio de Janeiro, 22240-002, Brazil

Location

Beneficência Portuguesa de São Paulo

São Paulo, São Paulo, 01323-001, Brazil

Location

Instituto do Coração do Hospital das Clínicas da Faculdade de Medicina de São Paulo

São Paulo, São Paulo, 05403-900, Brazil

Location

Related Publications (1)

• Mejia OAV, Sa MPBO, Deininger MO, Dallan LRP, Segalote RC, Oliveira MAP, Atik FA, Santos MAD, Silva PGMBE, Milani RM, Hueb AC, Monteiro R, Lima RC, Lisboa LAF, Dallan LAO, Puskas J, Jatene FB. Off-pump versus On-pump Coronary Artery Bypass Grafting in Frail Patients: Study Protocol for the FRAGILE Multicenter Randomized Controlled Trial. Braz J Cardiovasc Surg. 2017 Sep-Oct;32(5):428-434. doi: 10.21470/1678-9741-2017-0196.

  PMID: 29211225 DERIVED

Related Links

• São Paulo Research Foundation
• Zerbini Foundation
• Brazilian Cardiovascular Society

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Omar AV Mejia, MD, PhD

  InCor Heart Institute

  STUDY DIRECTOR

• Fábio B Jatene, MD, PhD

  InCor Heart Institute

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Treatment assignments will be performed in a blinded manner according to a blocked randomization scheme with a block size of ten, stratified according to the participating center.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Eligible patients will be randomly assigned to off-pump CABG or on-pump CABG procedure.

Study Record Dates

• First Submitted: August 29, 2014
• First Posted: January 15, 2015
• Study Start: January 1, 2019
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2025
• Last Updated: March 5, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1); BR (6)