Clinical trial NCT03909581: EndoACAB vs PCI for LAD Revascularization
Official title: Randomized Study Of Endoscopic Coronary Arterial Bypass Versus Percutaneous Coronary Intervention for Left Anterior Descending Artery Revascularization
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Coronary Artery Disease
Cardiovascular Diseases
Myocardial Ischemia
Keywords: CABG
EndoCAB
PCI
Lead sponsor: National Research Center of Surgery, Russia
Sponsor class: OTHER_GOV
First posted: 2019-04-10
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: MACCE
timeFrame: 1 year
Secondary outcomes:
measure: Procedural success
timeFrame: 1 year
measure: Pain assessment
timeFrame: 1 year
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: A.V. Vishnevsky National Medical Research Center of Surgery.
Study officials:
References: