EndoACAB vs PCI for LAD Revascularization (ENPILА)

Randomized Study Of Endoscopic Coronary Arterial Bypass Versus Percutaneous Coronary Intervention for Left Anterior Descending Artery Revascularization

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.

Study Overview

• Status: Unknown
• Conditions: Myocardial Ischemia; Cardiovascular Diseases; Coronary Artery Disease
• Intervention / Treatment: Procedure: Endoscopic coronary arterial bypass; Procedure: Percutaneous Coronary Intervention

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.

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Russian Federation
  • Moscow, Russian Federation, 117997
    • Recruiting
    • A.V. Vishnevsky National Medical Research Center of Surgery.
    • Contact: Vadim A Popov; Phone Number: +7 9166706609; Email: drpopov@mail.ru

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Endoscopic coronary arterial bypass; is defined, for the purposes of this trial, as a planned off-pump minimally invasive (sternal-sparing), isolated LIMA-LAD revascularization	Procedure: Endoscopic coronary arterial bypass; is defined, for the purposes of this trial, as a planned off-pump minimally invasive (sternal-sparing), isolated LIMA-LAD revascularization (50 participants); Other Names: EndoCAB
Active Comparator: Percutaneous Coronary Intervention; will be performed using standard techniques at the discretion of the operator	Procedure: Percutaneous Coronary Intervention; will be performed using standard techniques at the discretion of the operator (50 participants); Other Names: PCI

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
MACCE	Major adverse cardiac and cerebral events (MACCE), including death,a composite of major cardiac and cerebrovascular events, i.e. the first occurrence of any of the following events: Death from any cause From cardiovascular causes From noncardiovascular causes Stroke or transitory ischemic attack (TIA) MI Hospitalization for repeat revascularization procedure, target (vessel) revascularization by means of PCI or CABG.	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Procedural success	The treatment will be considered successful when a complete hybrid revascularisation in the absence of complications during the index hospitalization has been achieved.	1 year
Pain assessment	assessment of visual analogue scale E.C. Huskisson	1 year

Collaborators and Investigators

• Sponsor: National Research Center of Surgery, Russia

Study record dates

Study Major Dates

• Study Start (Actual): February 10, 2018
• Primary Completion (Anticipated): May 1, 2021
• Study Completion (Anticipated): May 1, 2021

Study Registration Dates

• First Submitted: February 26, 2019
• First Submitted That Met QC Criteria: April 9, 2019
• First Posted (Actual): April 10, 2019

Study Record Updates

• Last Update Posted (Actual): April 10, 2019
• Last Update Submitted That Met QC Criteria: April 9, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Keywords: PCI; CABG; EndoCAB
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease; Myocardial Ischemia; Cardiovascular Diseases; Ischemia
• Other Study ID Numbers: 7t7sci9q

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No