Funcional Recovery After Minithoracotomy or Sternotomy for CABG in Frail Patients

Official title

Functional Recovery After Coronary Artery Bypass Graft Surgery in Frail Patients: Randomized Clinical Trial Between Minithoracotomy Versus Sternotomy.

Overview

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

• Procedure Minimally 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.
• Procedure Conventional 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.

Primary outcome measures

• Change From Baseline in the SF-36 Physical Component Summary Score at 30 Days [Time frame: 30 days]

Secondary outcome measures (12)

• Incidence of Major Adverse Cardiovascular and Cerebrovascular Events [Time frame: Up to 30 days after surgery]
• All-Cause Mortality [Time frame: Up to 30 days after surgery]
• Perioperative Myocardial Infarction [Time frame: Up to 30 days after surgery]
• Stroke [Time frame: Up to 30 days after surgery]
• Repeat Coronary Revascularization [Time frame: Up to 30 days after surgery]
• Postoperative Angina [Time frame: Up to 30 days after surgery]
• Duration of Mechanical Ventilation [Time frame: Up to 30 days after surgery]
• Prolonged Mechanical Ventilation [Time frame: Up to 30 days after surgery]
• Intensive Care Unit Length of Stay [Time frame: Up to 30 days after surgery]
• Hospital Length of Stay [Time frame: Up to 30 days after surgery]
• Time to Return to Usual Activities [Time frame: Up to 30 days after surgery]
• Postoperative Pain Intensity [Time frame: Postoperative days 1, 2, and 3]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07742475 · SDC6277/26/034

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗