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Author Spotlight: Enhancing Coronary Artery Revascularization
Published on: September 15, 2023
Off-pump versus On-pump Coronary Artery Bypass Grafting in Frail Patients: Study Protocol for the FRAGILE Multicenter
Omar Asdrúbal Vilca Mejía1, Michel Pompeu Barros Oliveira Sá1,2, Maurilio Onofre Deininger3
1Instituto do Coração do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo (InCor-HCFMUSP), São Paulo, SP, Brazil.
Insights
The FRAGILE trial investigates if off-pump coronary artery bypass grafting (CABG) benefits frail patients. This study aims to determine if this technique reduces adverse events compared to traditional on-pump CABG in vulnerable individuals.
Area of Science:
- Cardiovascular Surgery
- Geriatric Medicine
- Clinical Trials
Background:
- Frailty is an understudied risk factor in cardiac surgery.
- Previous trials focused on low- to high-risk patients, excluding frail individuals.
- Off-pump CABG may be advantageous for patients with limited capacity to withstand surgical stress.
Purpose of the Study:
- To evaluate the potential benefits of off-pump coronary artery bypass grafting (CABG) in pre-frail and frail patients.
- To compare adverse cardiac and cerebrovascular events between off-pump and on-pump CABG in this population.
- To introduce the FRAGILE national, multicenter, randomized controlled trial.
Main Methods:
- A two-arm, parallel-group, multicenter, individually randomized controlled trial (1:1 ratio).
- Enrollment of 630 pre-frail and frail patients with blinded outcome assessment up to 3 years post-surgery.
- Primary outcomes include all-cause mortality, myocardial infarction, cardiac arrest, low cardiac output syndrome, stroke, and reintervention.
Main Results:
- The FRAGILE trial is designed to compare outcomes between off-pump and on-pump CABG.
- Key endpoints include mortality, major adverse cardiac and cerebrovascular events, and functional recovery.
- The study will provide crucial data on the efficacy and safety of off-pump CABG in frail patients.
Conclusions:
- The FRAGILE trial will determine the superiority of off-pump CABG over on-pump CABG in pre-frail and frail patients.
- This research addresses a critical gap in understanding surgical risk stratification for frail individuals undergoing CABG.
- Findings will inform clinical decision-making for optimizing surgical strategies in vulnerable patient populations.
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.
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