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

University of São Paulo (USP)

Status: Unknown

Conditions: Multivessel Coronary Artery Disease

Treatments: Procedure: Hybrid Revascularization; Procedure: Conventional Coronary Artery Bypass Surgery

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02226900

MERGING

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Hybrid Revascularization

Experimental group

Description:

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.

Treatment:

Procedure: Hybrid Revascularization

Conventional Surgical Coronary Bypass Grafting

Other group

Description:

Conventional Coronary Artery Bypass Grafts with in pump technique.

Treatment:

Procedure: Conventional Coronary Artery Bypass Surgery