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

University of Sao Paulo General Hospital

Status: Active, not recruiting

Conditions: Coronary Artery Disease; Frail Elderly

Treatments: Other: On-pump coronary-artery bypass grafting; Other: Off-pump coronary-artery bypass grafting

Study type: Interventional

Funder types: Other

Identifiers

NCT02338947

Sao Paulo Research Foundation (Other Grant/Funding Number)

USaoPauloGH1000

Details and patient eligibility

About

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.

Full description

The FRAGILE protocol is a national multicenter randomized controlled trial (RCT), conducted in 6 Brazilian institutions. The study is already approved by a certified ethics committee. Funding is provided by a grant from São Paulo Research Foundation (FAPESP), which otherwise will not have any role in the conduct of the study nor in the analysis nor in the reporting of data. A confidentiality agreement regarding data use and the data safety will be monitored by an independent monitoring board. All the authors will provide revisions and comments and be testifying for the accuracy and completeness of the report, as well as for the fidelity of the report to the study protocol.

Enrollment: 440 patients

Sex: All

Ages: 60+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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440 participants in 2 patient groups

Off-pump coronary-artery bypass grafting - OPCAB

Active Comparator group

Description:

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.

Treatment:

Other: Off-pump coronary-artery bypass grafting

On-pump coronary-artery bypass grafting - CABG

Active Comparator group

Description:

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.

Treatment:

Other: On-pump coronary-artery bypass grafting