Frailty is a major predictor of adverse outcomes following coronary artery bypass grafting (CABG), being associated with increased postoperative complications, prolonged hospitalization, delayed functional recovery, and reduced quality of life. Although minimally invasive coronary surgery (MICS) through left minithoracotomy has been associated with reduced surgical trauma and faster recovery in selected patients, its benefits have not been evaluated in a randomized trial specifically involving frail patients.
The MINI FRAGILE trial is a prospective, multicenter, randomized, open-label clinical trial designed to compare minimally invasive CABG performed through left anterior minithoracotomy with conventional median sternotomy in patients aged 60 years or older with pre-frailty or frailty undergoing surgical coronary revascularization. Eligible participants will be randomized in a 1:1 ratio to either surgical approach.
The primary objective is to determine whether minimally invasive CABG improves functional recovery, assessed by the change in the physical component of the SF-36 Health Survey 30 days after surgery. Secondary outcomes include major adverse cardiovascular events, mortality, intensive care unit and hospital length of stay, duration of mechanical ventilation, return to usual activities, surgical site infection, perioperative complications, postoperative pain, readmission, and adherence to enhanced recovery measures. The results of this trial are expected to provide high-quality evidence regarding the optimal surgical approach for frail patients requiring coronary artery bypass grafting.
Inclusion Criteria:
Age 60 years or older.
Diagnosis of coronary artery disease with an established indication for coronary artery bypass grafting.
Coronary anatomy considered suitable for complete surgical revascularization through a left anterolateral minithoracotomy, including suitable distal coronary targets with a luminal diameter of at least 1.5 mm.;
> Alternatively, coronary anatomy suitable for a planned hybrid revascularization strategy, with coronary territories not treated surgically considered amenable to percutaneous coronary intervention.
Presence of pre-frailty or frailty, defined by at least 2 of the following Fried frailty criteria:
Ability and willingness to provide written informed consent.
Exclusion Criteria:
fabioserrajr@outlook.com+551126615014
Because of the nature of the surgical interventions, neither participants nor treating clinicians can be blinded to treatment allocation. Patient-reported quality-of-life assessments and clinical outcomes will be collected according to standardized study procedures.
Participants undergo coronary artery bypass grafting through a left anterior minithoracotomy with or without cardiopulmonary bypass, according to the surgical plan. Standardized perioperative enhanced recovery measures are applied.
Participants undergo conventional coronary artery bypass grafting through median sternotomy with or without cardiopulmonary bypass according to institutional practice. Postoperative care follows standard institutional protocols.
omar.mejia@incor.usp.br+551126615014
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