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

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.

Study Overview

• Status: Unknown
• Conditions: Multivessel Coronary Artery Disease
• Intervention / Treatment: Procedure: Hybrid Revascularization; Procedure: Conventional Coronary Artery Bypass Surgery

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • SP
    • São Paulo, SP, Brazil, 05403000
      • InCor -Faculdade de Medicina da Universidade de São Paulo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Procedure: 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.
Other: Conventional Surgical Coronary Bypass Grafting; Conventional Coronary Artery Bypass Grafts with in pump technique.	Procedure: Conventional Coronary Artery Bypass Surgery; On pump coronary artery by-pass surgery; Other Names: Surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility of Revascularization Procedure Proposed by the Heart Team	The primary endpoint of this pilot study is the feasibility of revascularization planned preoperatively by the Heart team in the absence of adverse events (death, myocardial infarction, stroke, or unplanned revascularization) at 30 days.	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Major Adverse Cardiovascular Events	Composite and isolated measure of adverse events (all-cause death, myocardial infarction, stroke, or unplanned revascularization) at 1 year and annually up to 5 years.	1 year
Major Adverse Cardiovascular Events	Composite and isolated measure of adverse events (all-cause death, myocardial infarction, stroke, or unplanned revascularization) at 1 year and annually up to 5 years.	2 years
Major Adverse Cardiovascular Events	Composite and isolated measure of adverse events (all-cause death, myocardial infarction, stroke, or unplanned revascularization) at 1 year and annually up to 5 years.	3 years
Major Adverse Cardiovascular Events	Composite and isolated measure of adverse events (all-cause death, myocardial infarction, stroke, or unplanned revascularization) at 1 year and annually up to 5 years.	4 years
Major Adverse Cardiovascular Events	Composite and isolated measure of adverse events (all-cause death, myocardial infarction, stroke, or unplanned revascularization) at 1 year and annually up to 5 years.	5 years
Major Adverse Cardiovascular Events	Composite and isolated measure of adverse events (all-cause death, myocardial infarction, stroke, or unplanned revascularization) at 1 year and annually up to 5 years.	180 days
Safety	Cause of death (cardiac vs. non-cardiac); MI type; stroke type and severity.	1 year
Recurrence of Angina	Analyse patient recurrence of angina according to the Canadian Cardiovascular Society (CCS)	1 year
Medication Impact	Impact of antithrombotic agents and dual antiplatelet therapy in peri-procedural and long-term follow up safety end points.	1 year
Stent Thrombosis	Evaluate stent thrombosis according to the ARC (Academic Research Consortium) criteria	1 year
Bleeding	Hemorrhagic complications according to the BARC (Bleeding Academic Research Consortium) criteria	1 year
Neurological Events	Evaluate neurological complications by clinical tests (physical examination), vascular ultrasound and doppler perfusion measures.	1 year
Graft Patency	Patency of grafts and coronary artery disease at 1 year of follow-up evaluated by angiotomography	1 year
Clinical and Angiographic Scores Correlation with Prognostic	Evaluate the clinical correlation between the revascularization strategy and the usefulness of the SYNTAX score, ACEF score, clinical SYNTAX score, logistic EuroSCORE, STS score and InsCor for prognostic evaluation	1 year
Efficacy of the Strategy	Evaluate and compare the rate of repeated revascularization (target lesions and target vessels) in each one of both strategies.	1 year
Symptomatic Graft Occlusion	Evaluate patients that presented with recurrent ischaemia symptoms due to graft occlusion. The diagnostic must be done by angiography or angiotomography.	1 Year

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of life.		5 years
Cost	Evaluate and compare the final cost of the procedure and follow up period of the patients enrolled in each one of the strategies.	5 years
Hospital Stay	Evaluate and compare the period of hospital stay of the patients enrolled in each one of the strategies.	1 year

Collaborators and Investigators

• Sponsor: InCor Heart Institute
• Collaborators: Boston Scientific Corporation

Study record dates

Study Major Dates

• Study Start: August 1, 2014
• Primary Completion (Anticipated): December 1, 2018

Study Registration Dates

• First Submitted: August 21, 2014
• First Submitted That Met QC Criteria: August 25, 2014
• First Posted (Estimate): August 27, 2014

Study Record Updates

• Last Update Posted (Actual): November 29, 2018
• Last Update Submitted That Met QC Criteria: November 27, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Keywords: Multivessel Coronary Artery Disease; Hybrid Revascularization
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
• Other Study ID Numbers: MERGING