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NCT Number: NCT02338947

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

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.

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Key information

Conditions

Frail Elderly Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Artery Disease Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital de Messejana, Fortaleza, Ceará, Brazil

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: 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.

Other names: CABG

Primary outcomes

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

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

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

Secondary outcomes

  1. Operative time

    Time frame: From the start of anesthesia induction to the end of the surgical procedure

    Operative time in minutes

  2. Mechanical ventilation time

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

    Mechanical ventilation time in hours

  3. Hyperdynamic shock

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

    A cluster of symptoms that signals the onset of septic shock, often including a shaking chill, rapid rise in temperature, flushing of the skin, galloping pulse, and alternating rise and fall of the blood pressure

  4. New onset of atrial fibrillation

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

    12-lead electrocardiography (ECG) to confirm the diagnosis of new onset atrial fibrillation.

  5. Need for pacing >24 hours

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

    Patient who requires pacing >24 hours

  6. Renal replacement therapy

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

    Any type of renal replacement therapy in a patient who does not make continued use of this

  7. Pneumonia

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

    Physician or advanced practitioner documents the diagnosis in the medical record based on laboratory findings (e.g. positive sputum culture results from transtracheal fluid and/or bronchial washings) and/or radiological evidence (e.g. chest radiograph diagnostic of pulmonary infiltrates)

  8. Length of stay in intensive care unit

    Time frame: From the date of surgery until ICU discharge, assessed up to 30 days

    Total time in hours in Intensive Care Unit

  9. Length of stay in hospital

    Time frame: From the date of surgery until hospital discharge, assessed up to 90 days

    Total time in days in hospital

  10. Transfusion requirement

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

    Number of units of red blood cells transfused

  11. Recurrence of angina

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

    To analyse patient recurrence of angina according to the Canadian Cardiovascular Society (CCS)

  12. Rate of complete revascularization

    Time frame: Assessed at the end of the surgical procedure, evaluated within the intraoperative period, with an estimated duration of up to 600 minutes

    To evaluate and compare the rate of complete revascularization in each of the two strategies. Complete revascularization is defined as targeting arteries larger than 1.5 mm, with stenosis greater than 70%, and a good distal bed

  13. Evolution of frailty status

    Time frame: 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

    Frailty status will be assessed based on the Fried Frailty Criteria, which includes five components: unintentional weight loss, exhaustion, weakness (grip strength), slowness (gait speed), and low physical activity. Patients will be categorized as robust (0 criteria), pre-frail (1-2 criteria), or frail (3-5 criteria) at baseline and at follow-up. Changes in frailty status over time will be evaluated to determine progression, stability, or improvement

Other outcomes

  1. Delirium

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

    Delirium will be assessed using the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU) in the ICU and the Confusion Assessment Method (CAM) in the ward. According to the CAM-ICU instrument, delirium is diagnosed when features 1 and 2 are positive, along with either feature 3 or 4. The diagnosis of delirium requires the presence of baseline mental status changes, inattention, altered level of consciousness, or disorganized thinking. Patients will be evaluated with the CAM-ICU during their stay in the Intensive Care Unit and with the CAM after being transferred to the ward, but this assessment will only be conducted at the coordinating center

  2. Neurobehavioral outcomes after cardiac surgery

    Time frame: 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

    To evaluate the global cognitive status a examination test will be performed included 30 simple questions and tasks in a number of areas (orientation in time and place, repeating and recalling list of words, arithmetic, language use and comprehension, non-verbal memory)

  3. Quality of life after cardiac surgery

    Time frame: 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

    To evaluate the quality of life by the EuroQol-registration, a five domain and a visual analogue scale (VAS). The best state they can imagine is marked by 100 and the worst state marked by 0

  4. Cost

    Time frame: From the date of surgery until 12 months postoperatively, assessed up to 1 year

    The adjusted amount in US dollars of the total cost of coronary artery bypass surgery will be evaluated only at the coordinating center (InCor/HCFMUSP)

  5. Graft patency

    Time frame: From the date of surgery until 12 months postoperatively, assessed up to 1 year

    Patency of grafts and coronary artery disease at 1 year of follow-up evaluated by angiotomography

  6. Clinical and angiographic scores correlation with prognostic

    Time frame: From the date of surgery until 12 months postoperatively, assessed up to 1 year

    To evaluate the clinical correlation between the revascularization strategy and the usefulness of the SYNergy between percutaneous coronary intervention with TAXus and cardiac surgery score (SYNTAX score); age, creatinine and ejection fraction score (ACEF score); clinical SYNTAX score; European System for Cardiac Operative Risk Evaluation (EuroSCORE II); The Society of Thoracic Surgeon´s risk model (STS score) and Índice de Predição do INStituto do CORação (InsCor) for prognostic evaluation

  7. Evaluation of the patency of the radial artery and saphenous vein in the left coronary system after Myocardial Revascularization Surgery in patients with frailty criteria - FRAGILE TRIAL

    Time frame: From the date of surgery until 12 months postoperatively, assessed up to 1 year

    Primary objective

    To evaluate the patency of the RA graft in relation to the SV graft in the left coronary system in MVR surgery in patients with frailty criteria through coronary tomography angiography and bypasses with 12 months of follow-up.

    Secondary objective To evaluate the operative morbidity and mortality of patients undergoing MVR surgery where the RA graft was used in relation to the patient who underwent VS.

    To evaluate the patency of RA and SV in relation to the degree of obstruction of the treated coronary vessels

Sponsors and collaborators

Lead sponsor

University of Sao Paulo General Hospital

Other

Collaborators

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

Registry information

Official study title

A Multicenter, Prospective, Randomized, Clinical Trial Comparing Off-pump Versus On-pump Coronary Artery Bypass Grafting in Frail Patients

Acronym: FRAGILE

Important dates

Study start
2019
Primary completion
2024
Study completion
2025
First posted
Jan 15, 2015
Registry last updated
Mar 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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