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.