Coronary Artery Bypass Graft (CABG), Coronary Artery Disease, Frailty
Conditions
Keywords
Coronary Artery Bypass Grafting, Minimally Invasive Coronary Surgery, Minithoracotomy, Frailty, Functional Recovery
Brief summary
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.
Interventions
PROCEDUREMinimally Invasive Coronary Artery Bypass Grafting (MICS-CABG)
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.
PROCEDUREConventional Coronary Artery Bypass Grafting (Median Sternotomy)
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.
Sponsors
University of Sao Paulo General Hospital
Instituto Nacional de Cardiologia de Laranjeiras
Hospital e Maternidade Angelina Caron - SC
Santa Casa de Misericórdia de Maceió
Sancta Maggiore Itaim Hospital
Hospital Sao Vicente de Paulo e Hospital de Cidade, Passo Fundo, Brasil
Hospital Clínica Kennedy
Hospital Alberto Urquiza Wanderley
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
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.
Intervention model description
Participants will be randomized in a 1:1 ratio to undergo coronary artery bypass grafting either through a minimally invasive left anterior minithoracotomy or through conventional median sternotomy. Participants will receive only the assigned intervention and will be followed prospectively for assessment of functional recovery, quality of life, and perioperative clinical outcomes.
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
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: * Unintentional weight loss of at least 4.5 kg or at least 5% of body weight during the previous year. * Self-reported exhaustion or fatigue. * Reduced handgrip strength. * Slow walking speed. * Low level of physical activity. * Ability and willingness to provide written informed consent.
Exclusion criteria
* Requirement for emergency cardiac surgery. * Planned concomitant cardiac surgical procedure in addition to coronary artery bypass grafting. * Clinically significant peripheral vascular disease involving the femoral vessels that prevents safe peripheral cannulation for cardiopulmonary bypass, when peripheral cannulation may be required. * Contraindication to left minithoracotomy, including pleural adhesions, pleural thickening, or other thoracic conditions that prevent safe access to the mediastinum through the intercostal space. * Severe chronic obstructive pulmonary disease or another pulmonary condition that prevents safe single-lung ventilation or temporary compression of the left lung.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in the SF-36 Physical Component Summary Score at 30 Days | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Major Adverse Cardiovascular and Cerebrovascular Events | Up to 30 days after surgery | 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. |
| All-Cause Mortality | Up to 30 days after surgery | Percentage of participants who die from any cause within 30 days after the index surgical procedure. |
| Perioperative Myocardial Infarction | Up to 30 days after surgery | 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. |
| Stroke | Up to 30 days after surgery | Percentage of participants experiencing a new focal neurological deficit without complete spontaneous resolution within 24 hours after onset |
| Repeat Coronary Revascularization | Up to 30 days after surgery | 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. |
| Postoperative Angina | Up to 30 days after surgery | 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. |
| Duration of Mechanical Ventilation | Up to 30 days after surgery | Time, measured in hours, from postoperative admission to the intensive care unit while receiving invasive mechanical ventilation until the first successful extubation. |
| Prolonged Mechanical Ventilation | Up to 30 days after surgery | Percentage of participants requiring invasive mechanical ventilation for more than 24 hours after admission to the intensive care unit. |
| Intensive Care Unit Length of Stay | Up to 30 days after surgery | 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. |
| Hospital Length of Stay | Up to 30 days after surgery | 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 to Return to Usual Activities | Up to 30 days after surgery | 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. |
| Postoperative Pain Intensity | Postoperative days 1, 2, and 3 | 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. |
| Deep Surgical Site Infection | Up to 30 days after surgery | 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. |
| Acute Kidney Injury | Up to 48 hours after surgery | 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. |
| Reoperation | Up to 30 days after surgery | 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. |
| Conversion to Median Sternotomy | Intraoperative period | 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. |
| Complete Coronary Revascularization | Intraoperative period | 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. |
| Adherence to Enhanced Recovery Measures | From hospital admission to 6 hours after admission to postoperative intensive care unit | 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. |
| Extubation Within 6 Hours | Up to 6 hours after intensive care unit admission | Percentage of participants successfully extubated within 6 hours after postoperative admission to the intensive care unit. |
| All-Cause Hospital Readmission | Up to 30 days after surgery | 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. |
| Short Hospital Stay | Up to 6 days after surgery | Percentage of participants with an index hospital stay of fewer than 6 days. |
| Prolonged Hospital Stay | Up to 14 days after surgery | Percentage of participants with an index hospital stay of more than 14 days. |
Contacts
CONTACTFabio A S Lima Junior, MD
CONTACTOmar A V Mejia, MD PhD MBA
STUDY_DIRECTOROmar A V Mejia, MD PhD MBA
Instituto do Coração (Incor-HCFMUSP)
Outcome results
None listed