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(Reference retrieved automatically from Web of Science through information on FAPESP grant and its corresponding number as mentioned in the publication by the authors.)

Off-pump versus On-pump Coronary Artery Bypass Grafting in Frail Patients: Study Protocol for the FRAGILE Multicenter Randomized Controlled Trial

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Author(s):
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Vilca Mejia, Omar Asdrubal [1] ; Barros Oliveira Sa, Michel Pompeu [2, 3] ; Deininger, Maurilio Onofre [4] ; Palma Dallan, Luis Roberto [1] ; Segalote, Rodrigo Coelho [5] ; Praca de Oliveira, Marco Antonio [6] ; Atik, Fernando Antibas [7] ; dos Santos, Magaly Arrais [8] ; Melo de Barros e Silva, Pedro Gabriel [9] ; Milani, Rodrigo Mussi [10] ; Hueb, Alexandre Ciappina [1, 11] ; Monteiro, Rosangela [1] ; Lima, Ricardo Carvalho [2, 3] ; Ferreira Lisboa, Luiz Augusto [1] ; Oliveira Dallan, Luis Alberto [1] ; Puskas, John [1, 12] ; Jatene, Fabio Biscegli [1]
Total Authors: 17
Affiliation:
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[1] Univ Sao Paulo InCor HCFMUSP, Hosp Clin, Fac Med, Inst Coracao, Sao Paulo, SP - Brazil
[2] Univ Pernambuco UPE, Recife, PE - Brazil
[3] Pronto Socorro Cardiol Pernambuco PROCAPF, Div Cardiovasc Surg, Recife, PE - Brazil
[4] Unimed, Hosp Alberto Urquiza Wanderley, Joao Pessoa, Paraiba - Brazil
[5] Inst Nacl Cardiol, Rio De Janeiro, RJ - Brazil
[6] Hosp Beneficencia Portuguesa Sao Paulo, Sao Paulo, SP - Brazil
[7] Inst Cardiol Dist Fed, Brasilia, DF - Brazil
[8] Inst Dante Pazzanese Cardiol, Sao Paulo, SP - Brazil
[9] Total Cor Hosp, Sao Paulo, SP - Brazil
[10] Pontificia Univ Catol Parana PUCPR, Curitiba, Parana - Brazil
[11] Hosp Clin Samuel Libanio, Pouso Alegre, Minas Gerais - Brazil
[12] Mt Sinai Heart Mt Sinai St Lukes New York, New York, NY - USA
Total Affiliations: 12
Document type: Journal article
Source: Revista Brasileira de Cirurgia Cardiovascular; v. 32, n. 5, p. 428-434, 2017.
Web of Science Citations: 4
Abstract

Abstract Introduction: Advances 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. Methods: FRAGILE 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. Discussion: FRAGILE 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 registration: ClinicalTrials.gov, ID: NCT02338947. Registered on August 29th 2014; last updated on March 21st 2016. (AU)

FAPESP's process: 15/23972-3 - ofF-pump veRsus on-pump coronAry-artery bypass GraftIng in fragiLe patiEnts (FRAGILE)
Grantee:Fabio Biscegli Jatene
Support type: Research Projects - Thematic Grants