EndoACAB vs PCI for LAD Revascularization (ENPILА)

National Research Center of Surgery, Russia

Status: Unknown

Conditions: Coronary Artery Disease; Myocardial Ischemia; Cardiovascular Diseases

Treatments: Procedure: Endoscopic coronary arterial bypass; Procedure: Percutaneous Coronary Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT03909581

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Details and patient eligibility

About

The purpose of this study is to determine which treatment option is better for patients who have isolated coronary artery disease (blockages of one vessel supplying blood to the heart muscle). The treatment options compared in this study are:

1. Endoscopic coronary arterial bypass
2. Percutaneous Coronary Intervention. This study is aimed to determine the best treatment for patients with coronary artery disease.

Full description

Coronary artery disease (CAD), also known as coronary heart disease (CHD) involves the progressive narrowing of the arteries that nourish the heart muscle. CAD is the main cause of death in Russia.

Patients with LAD disease have worse coronary flow outcomes Currently established types of myocardial revascularization are coronary artery bypass grafting (CABG) and percutaneous coronary interventions (PCI). High effectiveness of CABG was proved by multiple studies. PCI is a first line therapy in the treatment of one vessel disease due to the less invasive approach and current technological possibilities of this revascularization method.

However, the established gold standard of multivessel coronary blockage treatment is CABG. It was reflected in the latest ESC/EACTS Guidelines on Myocardial Revascularization, due to the better early and late outcomes associated with the graft specifics.

On the other hand, standard CABD operation has a high injury and morbidity rate, which were factors for development of less invasive techniques of CABG.

According to the latest ESC/EACTS guidelines there are no advantages between PCI and CABG in the LAD disease treatment, both methods are Class I; level of evidence A.

The choice between myocardial revascularization methods in patients with LAD disease is the critical task.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• The presence of isolated lesions of LAD are available for revascularization PCI and EndoCAB
• Suitable candidate for both PCI and EndoCAB as determined by clinical assessment and angiogram review by an interventional cardiologist and a cardiac surgeon at the enrolling clinical site
• Age ≥ 18 years

Exclusion criteria

• Previous cardiac surgery of any kind, including CABG
• Previous thoracic surgery involving the left pleural space
• Need for concomitant vascular or other cardiac surgery during the index hospitalization (including, but not limited to, valve surgery, aortic resection, left ventricular aneurysmectomy, and carotid endarterectomy or stenting)
• Indication for chronic oral anticoagulation therapy at the time of randomization
• Extra-cardiac illness that is expected to limit survival to less than 5 years
• Allergy or hypersensitivity to any of the study drugs or devices used in the trial
• Therapy with an investigational drug, device or biologic within 1 year prior to randomization, or plan to enroll patient in additional investigational study during participation in this trial
• Unable to give informed consent or potential for noncompliance with the study protocol in the judgment of the investigator
• Ejection fraction of 40% or less Left ventricular dysfunction

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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100 participants in 2 patient groups

Endoscopic coronary arterial bypass

Active Comparator group

Description:

is defined, for the purposes of this trial, as a planned off-pump minimally invasive (sternal-sparing), isolated LIMA-LAD revascularization

Treatment:

Procedure: Endoscopic coronary arterial bypass

Percutaneous Coronary Intervention

Active Comparator group

Description:

will be performed using standard techniques at the discretion of the operator

Treatment:

Procedure: Percutaneous Coronary Intervention