• Omar Asdrúbal Vilca Mejía, Sá Michel Pompeu Barros Oliveira MPBO Instituto do Coração do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo (InCor-HCFMUSP), São Paulo, SP, , Maurilio Onofre Deininger, Luís Roberto Palma Dallan, Rodrigo Coelho Segalote, Marco Antonio Praça de Oliveira, Fernando Antibas Atik, Magaly Arrais Dos Santos, Silva Pedro Gabriel Melo de Barros E PGMBE Total Cor Hospital - São Paulo, SP, Brazil., Rodrigo Mussi Milani, Alexandre Ciappina Hueb, Rosangela Monteiro, Ricardo Carvalho Lima, Luiz Augusto Ferreira Lisboa, Luís Alberto Oliveira Dallan, John Puskas, and Fabio Biscegli Jatene.
• Instituto do Coração do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo (InCor-HCFMUSP), São Paulo, SP, Brazil.
• Rev Bras Cir Cardiovasc. 2017 Sep 1; 32 (5): 428-434.

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.

11 keywords...

hide…