Clinical trial NCT06794359: Minimally Invasive Coronary Artery Bypass Surgery in Patients With Multi Vessel Coronary Disease
Official title: Minimally Invasive Coronary Artery Bypass Surgery: Prospective and Randomized Study to Validate the Minimally Invasive Approach Through Left Anterior Mini Thoracotomy in Patients With Milti Vessel Coronary Disease
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Coronary Arterial Disease (CAD)
Coronary Artery Bypass
Keywords: CABG
MICS CABG
CAD
Lead sponsor: University of Sao Paulo General Hospital
Sponsor class: OTHER
Collaborators: name: Medtronic
name: Fundação de Amparo à Pesquisa do Estado de São Paulo
First posted: 2025-01-27
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this study is to evaluate the safety and feasibility of Minimally Invasive Coronary Artery Bypass surgery in selected patients ,with multi vessel coronary disease.

This trial is designed to be a pilot study that will gather comparative information on the clinical performance of the minimally invasive treatment, evaluated by the composite measure of all-cause death, myocardial infarction, stroke, or unplanned repeat revascularization - in hospital, 30-day and 6 months.

Detailed description: Minimally invasive surgery has been a breakthrough in medicine, especially in more developed countries. It represents an evolution of current techniques associated with new technologic devices, that allow a safe and effective procedure associated to an aesthetic benefit.

Invasive treatment of coronary artery disease has been on a plateau lately. Percutaneous treatment that emerged as a promise to replace surgical methods, has already shown its limitations, even with the use of drug-eluting stents. Traditional CABG (coronary artery bypass grafting surgery), which has been considered the gold standard, has been criticized for its high degree of invasiveness.

Based on this precept, interest has emerged in creating a surgical approach that causes less trauma. Surgical access using minimally invasive incisions are gaining space and have shown less postoperative pain, shorter hospital stays, earlier mobilization and functional recovery, in addition to reducing the costs of the procedure.

Cardiac surgery has some challenges that are beyond other specialties. The heart is a vital organ with intrinsic chronotropism that lies inside a rigid rib cage.

Specifically, in coronary artery bypass graft surgery (CABG), the thin caliber of the coronaries and their distribution throughout the cardiac territories creates even a greater challenge. However, new surgical techniques associated with new devices, demonstrated the viability of complete revascularization through a limited access incision.

In an attempt to minimize surgical trauma and the morbidities caused by conventional median sternotomy and the use of On Pump surgery, some alternatives have emerged with promising results.

Among those efforts, we can highlight the beginning of the coronary artery grafting surgery without the use of cardiopulmonary bypass (Off Pump CABG), followed by hybrid revascularization, minimally invasive surgery by lateral thoracotomy under direct vision, partially assisted robot surgery and fully endoscopic surgery with using robots.

Currently, minimally invasive surgery though mini lateral thoracotomy is the most common technique used. Initially it was used only for the treatment of the left anterior descending artery (LAD), but technology advances and surgical improvement allowed complete revascularization under direct vision. Surgery can be performed with or without the aid of cardiopulmonary bypass (CPB), treatment individualization is necessecary for every case.

This is a pilot study to evaluate the safety and feasibility of Minimally Invasive Coronary Artery Bypass surgery in selected patients ,with multi vessel coronary disease.

Eligibility criteria: Inclusion Criteria:

* Patients 18-years-old or older
* Isolated myocardial revascularization procedure
* Double or Triple-vessel disease with proximal or mid LAD disease with angiographic diameter stenosis \&amp;gt; 70% by visual analysis in all territories, requiring myocardial revascularization OR proximal LAD disease with angiographic diameter stenosis 50-70% by visual analysis in any territory but with invasive or non-invasive evidence of flow-limiting stenosis in all three territories, requiring myocardial revascularization
* Total SYNTAX score \&gt; 22 or low Syntax score unsuitable for PCI
* Clinical and anatomic eligibility for both Minimally invasive and Conventional CABG surgery as agreed to by surgical team.
* Silent ischemia, stable angina, unstable angina or recent MI

  - If recent MI, cardiac biomarkers must have returned to normal prior to randomization
* Ability to sign informed consent and comply with all study procedures

Exclusion Criteria:

* Reoperation
* Need for any concomitant cardiac surgery other than CABG (e.g. valve surgery, aortic repair, etc.), or intent that if the patient randomizes to surgery, any cardiac surgical procedure other than isolated CABG will be performed
* Left ventricle disfunction (EF\&amp;lt;40%)
* Chronic Pulmonary obstructive disease
* Renal failure disease
* Emergency surgery
* Obesity
* Sternum anatomic defects including pectus excavatum
* Peripheral vascular disease
* Ascending aorta severe calcification
* Non cardiac co-morbidities with life expectancy less than 1 year

Primary outcomes:
measure: Feasibility and safety of proposed revascularization through minimally invasive approach
timeFrame: Clinical follow-up intra hospitalar, 30-day and 6 months
Secondary outcomes:
measure: Intraoperative conversion rate
timeFrame: Intraoperative measure
measure: Complete revascularization rate
timeFrame: Intraoperative measure
measure: Postoperative bleeding volume
timeFrame: First 48 hours post-surgery
measure: Surgery duration
timeFrame: Intraoperative measure
measure: Length of orotracheal intubation
timeFrame: From oral intubation until extubation
measure: Length of ICU and hospital stay
timeFrame: From ICU admission to discharge
measure: Intra operative graft evaluation
timeFrame: This is a specific assessment carried out during the surgical procedure (intraoperative).
measure: Postoperative myocardial infarction
timeFrame: Within 48 hours following surgery
measure: Surgical Mortality
timeFrame: 30 days postoperatively
measure: Wound infection
timeFrame: From the date of surgery through 30 days postoperatively.
measure: Post operatative atrial fibrillation
timeFrame: Immediate postoperative: from the day of surgery to postoperative day 7. • Early late postoperative: from postoperative day 8 to day 30. • Late outpatient assessment: between 30 days and 6 months post-surgery.
measure: Neurological events
timeFrame: Stroke related to surgery will be acessed in phases: • Immediate postoperative: from the day of surgery to postoperative day 7. • Early late postoperative: from postoperative day 8 to day 30. • Late outpatient assessment: between 30 days and 6 months po
measure: Quality of Life Assessed by EQ-5D-5L
timeFrame: Within 6 Months After Surgery
measure: Safety Assessed by Incidence of Major Adverse Cardiovascular and Cerebral Events (MACCE) Postoperatively
timeFrame: At 30 days and 6 months following hospital discharge
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: INCOR - Heart Institute from the University of Sao Paulo
state: SP
Study officials:
affiliation: INCOR - Heart Institute from the University of Sao Paulo
name: Luis Roberto Palma Dallan, MD
role: STUDY_DIRECTOR
affiliation: INCOR - Heart Institute from the University of Sao Paulo
name: Luis Alberto Oliveira Dallan, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: