Myocardial Hybrid Revascularization Versus Coronary artERy Bypass GraftING for Complex Triple-vessel Disease

NCT ID: NCT02226900

Last Updated: 2018-11-29

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-08-31

Brief Summary

This is a pilot randomized study that aim to assess the safety and feasibility of a hybrid myocardial revascularization strategy (coronary artery by-pass graft and percutaneous intervention) in comparison with conventional surgical coronary bypass grafting.

Conditions

Multivessel Coronary Artery Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Hybrid Revascularization

The hybrid myocardial revascularization group will be accomplished by a two-step scheme, comprised by off-pump LIMA-to-left anterior descending grafting, followed by percutaneous coronary interventions with Promus Element (everolimus second generation drug eluting stent) for the remaining coronary lesions.

Group Type: EXPERIMENTAL

Hybrid Revascularization

Intervention Type: PROCEDURE

Off-pump LIMA connected to the left anterior descending artery followed by percutaneous coronary intervention with drug eluting stents to the other territories.

Conventional Surgical Coronary Bypass Grafting

Conventional Coronary Artery Bypass Grafts with in pump technique.

Group Type: OTHER

Conventional Coronary Artery Bypass Surgery

Intervention Type: PROCEDURE

On pump coronary artery by-pass surgery

Interventions

Hybrid Revascularization

Off-pump LIMA connected to the left anterior descending artery followed by percutaneous coronary intervention with drug eluting stents to the other territories.

Intervention Type: PROCEDURE

Conventional Coronary Artery Bypass Surgery

On pump coronary artery by-pass surgery

Intervention Type: PROCEDURE

Other Intervention Names

Surgery

Eligibility Criteria

Inclusion Criteria

• Triple-vessel disease with proximal or mid LAD disease with angiographic diameter stenosis > 70% by visual analysis in all three territories, requiring myocardial revascularization OR triple-vessel disease with proximal or mid 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 > 22
• LCx and RCA territories estimated to be equivalently revascularized by either PCI or CABG, with at least one major non-LAD vessel to be treated
• Clinical and anatomic eligibility for both PCI and CABG as agreed to by both interventional and surgical consensus

• Interventionalist determines PCI appropriateness and eligibility
• Surgeon determines surgical appropriateness and eligibility
• 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

• Prior PCI or CABG at any time prior to randomization
• 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
• Patients unable to tolerate, obtain or comply with dual antiplatelet therapy for at least one year
• Patients requiring additional surgery (cardiac or non cardiac) within one year
• The presence of any clinical or anatomical condition(s) which leads the participating interventional cardiologist to believe that clinical equipoise is not present (i.e. the patient should not be treated by PCI, but rather should be managed with CABG or medical therapy - reasons will be documented)
• The presence of any clinical or anatomical condition(s) which leads the participating cardiac surgeon to believe that clinical equipoise is not present (i.e. the patient should not be treated by CABG, but rather should be managed with PCI. or medical therapy - reasons will be documented)
• Non cardiac co-morbidities with life expectancy less than 1 year
• Other investigational drug or device studies that have not reached their primary endpoint.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Boston Scientific Corporation

INDUSTRY

Sponsor Role: collaborator

InCor Heart Institute

OTHER

Sponsor Role: lead

Responsible Party

Pedro A. Lemos

Pedro A. Lemos, Professor of Medicine, InCor Heart Institute

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

InCor -Faculdade de Medicina da Universidade de São Paulo

São Paulo, São Paulo, Brazil

Countries

Brazil

Other Identifiers

MERGING

Identifier Type: -

Identifier Source: org_study_id