Funcional Recovery After Minithoracotomy or Sternotomy for CABG in Frail Patients

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.

Conditions

• Frailty
• Coronary Artery Disease
• Coronary Artery Bypass Graft (CABG)

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.

Sponsors & Collaborators

• Instituto Nacional de Cardiologia de Laranjeiras

  collaborator OTHER

• Hospital e Maternidade Angelina Caron - SC

  collaborator UNKNOWN

• Santa Casa de Misericórdia de Maceió

  collaborator OTHER

• Sancta Maggiore Itaim Hospital

  collaborator UNKNOWN

• Hospital Sao Vicente de Paulo e Hospital de Cidade, Passo Fundo, Brasil

  collaborator UNKNOWN

• Hospital Clínica Kennedy

  collaborator OTHER

• Hospital Alberto Urquiza Wanderley

  collaborator UNKNOWN

• University of Sao Paulo General Hospital

  lead OTHER

Principal Investigators

• Omar A V Mejia, MD PhD MBA · Instituto do Coração (Incor-HCFMUSP)

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

60 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-09-30

Primary Completion

2027-08-31

Completion

2027-08-31