Clinical trial NCT02338947: Off-pump Versus On-pump Coronary Artery Bypass Grafting in Frail Patients
Official title: A Multicenter, Prospective, Randomized, Clinical Trial Comparing Off-pump Versus On-pump Coronary Artery Bypass Grafting in Frail Patients
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Frail Elderly
Coronary Artery Disease
Keywords: Frail elderly
Coronary artery bypass surgery
Off-pump
On-pump
Randomized controlled trial
Lead sponsor: University of Sao Paulo General Hospital
Sponsor class: OTHER
Collaborators: name: Beneficência Portuguesa de São Paulo
name: Instituto Nacional de Cardiologia de Laranjeiras
name: Clinical Hospital Samuel Libânio of Pouso Alegre
name: Hospital do Coração de Messejana Dr. Carlos Alberto Studart
First posted: 2015-01-15
Enrollment: 440
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Eligible patients will be randomly assigned to off-pump CABG or on-pump CABG procedure.
Primary purpose: TREATMENT

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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Major adverse cardiac and cerebrovascular events after OPCAB and CABG in pre-frail and frail patients
timeFrame: From the date of surgery until 30 days postoperatively, assessed up to 30 days
Secondary outcomes:
measure: Operative time
timeFrame: From the start of anesthesia induction to the end of the surgical procedure
measure: Mechanical ventilation time
timeFrame: From the initiation of mechanical ventilation in the operating room or ICU to the time of successful extubation
measure: Hyperdynamic shock
timeFrame: From the date of surgery until 30 days postoperatively, assessed up to 30 days
measure: New onset of atrial fibrillation
timeFrame: From the date of surgery until 30 days postoperatively, assessed up to 30 days
measure: Need for pacing >24 hours
timeFrame: From the date of surgery until 30 days postoperatively, assessed up to 30 days
measure: Renal replacement therapy
timeFrame: From the date of surgery until 30 days postoperatively, assessed up to 30 days
measure: Pneumonia
timeFrame: From the date of surgery until 30 days postoperatively, assessed up to 30 days
measure: Length of stay in intensive care unit
timeFrame: From the date of surgery until ICU discharge, assessed up to 30 days
measure: Length of stay in hospital
timeFrame: From the date of surgery until hospital discharge, assessed up to 90 days
measure: Transfusion requirement
timeFrame: From the date of surgery until 30 days postoperatively, assessed up to 30 days
measure: Recurrence of angina
timeFrame: From the date of surgery until 30 days postoperatively, assessed up to 30 days
measure: Rate of complete revascularization
timeFrame: Assessed at the end of the surgical procedure, evaluated within the intraoperative period, with an estimated duration of up to 600 minutes
measure: Evolution of frailty status
timeFrame: 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
Other outcomes:
measure: Delirium
timeFrame: From the date of surgery until 30 days postoperatively, assessed up to 30 days
measure: Neurobehavioral outcomes after cardiac surgery
timeFrame: 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
measure: Quality of life after cardiac surgery
timeFrame: 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
measure: Cost
timeFrame: From the date of surgery until 12 months postoperatively, assessed up to 1 year
measure: Graft patency
timeFrame: From the date of surgery until 12 months postoperatively, assessed up to 1 year
measure: Clinical and angiographic scores correlation with prognostic
timeFrame: From the date of surgery until 12 months postoperatively, assessed up to 1 year
measure: 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
timeFrame: From the date of surgery until 12 months postoperatively, assessed up to 1 year
Locations:
city: Atlanta
country: United States
facility: Emory University School of Medicine
state: Georgia
city: Fortaleza
country: Brazil
facility: Hospital de Messejana
state: Ceará
city: Pouso Alegre
country: Brazil
facility: Hospital das Clínicas Samuel Libânio
state: Minas Gerais
city: João Pessoa
country: Brazil
facility: Hospital Alberto Urquiza Wanderley
state: Paraiba
city: Rio De Janeiro
country: Brazil
facility: Instituto Nacional de Cardiologia de Laranjeiras
city: São Paulo
country: Brazil
facility: Beneficência Portuguesa de São Paulo
city: São Paulo
country: Brazil
facility: Instituto do Coração do Hospital das Clínicas da Faculdade de Medicina de São Paulo
Study officials:
affiliation: InCor Heart Institute
name: Omar AV Mejia, MD, PhD
role: STUDY_DIRECTOR
affiliation: InCor Heart Institute
name: Fábio B Jatene, MD, PhD
role: STUDY_CHAIR
References:
citation: 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.