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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
194
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.
Change From Baseline in the SF-36 Physical Component Summary Score at 30 Days
The Short Form-36 Health Survey, version 2 (SF-36v2), will be administered before surgery and 30 days after surgery. The primary outcome is the change in the Physical Component Summary score, calculated as the 30-day score minus the baseline score. SF-36 scores are transformed to a 0-to-100 scale, with higher scores indicating better self-reported physical health and functioning.
Time frame: 30 days
Incidence of Major Adverse Cardiovascular and Cerebrovascular Events
Percentage of participants experiencing at least one component of the composite outcome of perioperative myocardial infarction, angina, repeat coronary revascularization, or stroke. Each participant will be counted once in the composite, regardless of the number of events experienced. Perioperative myocardial infarction will be defined according to the prespecified study criteria using postoperative high-sensitivity troponin levels and evidence of new myocardial ischemia. Stroke will be defined as a focal neurological deficit without complete spontaneous resolution within 24 hours.
Time frame: Up to 30 days after surgery
All-Cause Mortality
Percentage of participants who die from any cause within 30 days after the index surgical procedure.
Time frame: Up to 30 days after surgery
Perioperative Myocardial Infarction
Percentage of participants experiencing perioperative myocardial infarction, defined as a postoperative high-sensitivity cardiac troponin concentration greater than 500 times the assay upper reference limit, or greater than 35 times the upper reference limit accompanied by evidence of new myocardial ischemia. Evidence of ischemia may include new ischemic electrocardiographic changes, documented coronary artery or graft occlusion, new loss of viable myocardium, or a new regional ventricular wall-motion abnormality.
Time frame: Up to 30 days after surgery
Stroke
Percentage of participants experiencing a new focal neurological deficit without complete spontaneous resolution within 24 hours after onset
Time frame: Up to 30 days after surgery
Repeat Coronary Revascularization
Percentage of participants requiring repeat surgical or percutaneous coronary revascularization after the index procedure. This includes surgical revision or creation of coronary anastomoses and percutaneous coronary intervention performed after the index surgery.
Time frame: Up to 30 days after surgery
Postoperative Angina
Percentage of participants reporting postoperative angina. Angina is defined as retrosternal chest discomfort, with or without radiation, that worsens with exertion and/or improves with vasodilator therapy and is neither pleuritic nor reproducible by chest-wall palpation.
Time frame: Up to 30 days after surgery
Duration of Mechanical Ventilation
Time, measured in hours, from postoperative admission to the intensive care unit while receiving invasive mechanical ventilation until the first successful extubation.
Time frame: Up to 30 days after surgery
Prolonged Mechanical Ventilation
Percentage of participants requiring invasive mechanical ventilation for more than 24 hours after admission to the intensive care unit.
Time frame: Up to 30 days after surgery
Intensive Care Unit Length of Stay
Time, measured in hours, from postoperative admission to the intensive care unit until documentation that the participant meets the prespecified criteria for discharge from the intensive care unit.
Time frame: Up to 30 days after surgery
Hospital Length of Stay
Time, measured in hours, from hospital admission for the index surgical procedure until documentation that the participant meets the prespecified objective criteria for hospital discharge.
Time frame: Up to 30 days after surgery
Time to Return to Usual Activities
Number of days from the index surgery until the participant reports returning to the same or a better level of usual activities or functional status compared with the preoperative level.
Time frame: Up to 30 days after surgery
Postoperative Pain Intensity
Postoperative pain intensity measured using an 11-point Numeric Rating Scale ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst pain imaginable. Pain scores will be assessed separately on postoperative days 1, 2, and 3.
Time frame: Postoperative days 1, 2, and 3
Deep Surgical Site Infection
Percentage of participants with a deep surgical site infection involving the primary thoracic surgical incision. Infection will be identified by compatible clinical findings, such as fever, purulent drainage, wound instability, or deep tissue involvement, and confirmed by imaging, microbiological testing, surgical findings.
Time frame: Up to 30 days after surgery
Acute Kidney Injury
Percentage of participants developing acute kidney injury, defined as an increase in serum creatinine of at least 0.3 mg/dL within 48 hours after surgery.
Time frame: Up to 48 hours after surgery
Reoperation
Percentage of participants requiring an additional surgical procedure to revise the index coronary revascularization, treat a complication caused by the index procedure, or re-enter the chest through the original or an alternative surgical access.
Time frame: Up to 30 days after surgery
Conversion to Median Sternotomy
Percentage of participants assigned to minimally invasive coronary artery bypass grafting who require intraoperative conversion from left minithoracotomy to median sternotomy for completion of the operation or management of a complication.
Time frame: Intraoperative period
Complete Coronary Revascularization
Percentage of participants in whom all coronary targets included in the final preoperative revascularization plan are successfully treated during the index procedure, either surgically or as part of a planned hybrid revascularization strategy, as documented in the operative and procedural records.
Time frame: Intraoperative period
Adherence to Enhanced Recovery Measures
Number of prespecified enhanced recovery measures successfully completed for each participant, ranging from 0 to 5. The measures are: abbreviated preoperative fasting, avoidance of preoperative sedatives or anxiolytics, opioid-sparing anesthesia, regional anesthesia before or after surgery, and extubation within 6 hours after intensive care unit admission. Higher scores indicate greater protocol adherence.
Time frame: From hospital admission to 6 hours after admission to postoperative intensive care unit
Extubation Within 6 Hours
Percentage of participants successfully extubated within 6 hours after postoperative admission to the intensive care unit.
Time frame: Up to 6 hours after intensive care unit admission
All-Cause Hospital Readmission
Percentage of participants readmitted to any hospital for any reason after discharge from the index hospitalization. Transfers to a supporting hospital solely for warfarin dose adjustment will not be classified as readmissions.
Time frame: Up to 30 days after surgery
Short Hospital Stay
Percentage of participants with an index hospital stay of fewer than 6 days.
Time frame: Up to 6 days after surgery
Prolonged Hospital Stay
Percentage of participants with an index hospital stay of more than 14 days.
Time frame: Up to 14 days after surgery
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