IntroductionAdvances in modern medicine have led to people living longer and healthier
lives. Frailty is an emerging concept in medicine yet to be explored as a
risk factor in cardiac surgery. When it comes to CABG surgery, randomized
controlled clinical trials have primarily focused on low-risk (ROOBY,
CORONARY), elevated-risk (GOPCABE) or high-risk patients (BBS), but not on
frail patients. Therefore, we believe that off-pump CABG could be an
important technique in patients with limited functional capacity to respond
to surgical stress. In this study, the authors introduce the new national,
multicenter, randomized, controlled trial "FRAGILE", to be developed in the
main cardiac surgery centers of Brazil, to clarify the potential benefit of
off-pump CABG in frail patients.MethodsFRAGILE is a two-arm, parallel-group, multicentre, individually randomized
(1:1) controlled trial which will enroll 630 patients with blinded outcome
assessment (at 30 days, 6 months, 1 year, 2 years and 3 years), which aims
to compare adverse cardiac and cerebrovascular events after off-pump
versus on-pump CABG in pre-frail and frail patients.
Primary outcomes will be all-cause mortality, acute myocardial infarction,
cardiac arrest with successful resuscitation, low cardiac output
syndrome/cardiogenic shock, stroke, and coronary reintervention. Secondary
outcomes will be major adverse cardiac and cerebrovascular events, operative
time, mechanical ventilation time, hyperdynamic shock, new onset of atrial
fibrillation, renal replacement therapy, reoperation for bleeding,
pneumonia, length of stay in intensive care unit, length of stay in
hospital, number of units of blood transfused, graft patency, rate of
complete revascularization, neurobehavioral outcomes after cardiac surgery,
quality of life after cardiac surgery and costs.DiscussionFRAGILE trial will determine whether off-pump CABG is superior to
conventional on-pump CABG in the surgical treatment of pre-frail and frail
patients.Trial registrationClinicalTrials.gov, ID: NCT02338947. Registered on August 29th
2014; last updated on March 21st 2016.