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

Primary Purpose

Multivessel Coronary Artery Disease

Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Hybrid Revascularization
Conventional Coronary Artery Bypass Surgery
Sponsored by
InCor Heart Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multivessel Coronary Artery Disease focused on measuring Multivessel Coronary Artery Disease, Hybrid Revascularization

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts 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.

Sites / Locations

  • InCor -Faculdade de Medicina da Universidade de São Paulo

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Hybrid Revascularization

Conventional Surgical Coronary Bypass Grafting

Arm 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.

Conventional Coronary Artery Bypass Grafts with in pump technique.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
Safety
Cause of death (cardiac vs. non-cardiac); MI type; stroke type and severity.
Recurrence of Angina
Analyse patient recurrence of angina according to the Canadian Cardiovascular Society (CCS)
Medication Impact
Impact of antithrombotic agents and dual antiplatelet therapy in peri-procedural and long-term follow up safety end points.
Stent Thrombosis
Evaluate stent thrombosis according to the ARC (Academic Research Consortium) criteria
Bleeding
Hemorrhagic complications according to the BARC (Bleeding Academic Research Consortium) criteria
Neurological Events
Evaluate neurological complications by clinical tests (physical examination), vascular ultrasound and doppler perfusion measures.
Graft Patency
Patency of grafts and coronary artery disease at 1 year of follow-up evaluated by angiotomography
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
Efficacy of the Strategy
Evaluate and compare the rate of repeated revascularization (target lesions and target vessels) in each one of both strategies.
Symptomatic Graft Occlusion
Evaluate patients that presented with recurrent ischaemia symptoms due to graft occlusion. The diagnostic must be done by angiography or angiotomography.

Full Information

First Posted
August 21, 2014
Last Updated
November 27, 2018
Sponsor
InCor Heart Institute
Collaborators
Boston Scientific Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT02226900
Brief Title
Myocardial Hybrid Revascularization Versus Coronary artERy Bypass GraftING for Complex Triple-vessel Disease
Acronym
MERGING
Official Title
Myocardial Hybrid Revascularization Versus Coronary artERy Bypass GraftING for Complex Triple-vessel Disease
Study Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Unknown status
Study Start Date
August 2014 (undefined)
Primary Completion Date
December 2018 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
InCor Heart Institute
Collaborators
Boston Scientific Corporation

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multivessel Coronary Artery Disease
Keywords
Multivessel Coronary Artery Disease, Hybrid Revascularization

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Hybrid Revascularization
Arm Type
Experimental
Arm 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.
Arm Title
Conventional Surgical Coronary Bypass Grafting
Arm Type
Other
Arm Description
Conventional Coronary Artery Bypass Grafts with in pump technique.
Intervention Type
Procedure
Intervention Name(s)
Hybrid Revascularization
Intervention Description
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
Intervention Name(s)
Conventional Coronary Artery Bypass Surgery
Other Intervention Name(s)
Surgery
Intervention Description
On pump coronary artery by-pass surgery
Primary Outcome Measure Information:
Title
Feasibility of Revascularization Procedure Proposed by the Heart Team
Description
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.
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Major Adverse Cardiovascular Events
Description
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.
Time Frame
1 year
Title
Major Adverse Cardiovascular Events
Description
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.
Time Frame
2 years
Title
Major Adverse Cardiovascular Events
Description
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.
Time Frame
3 years
Title
Major Adverse Cardiovascular Events
Description
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.
Time Frame
4 years
Title
Major Adverse Cardiovascular Events
Description
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.
Time Frame
5 years
Title
Major Adverse Cardiovascular Events
Description
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.
Time Frame
180 days
Title
Safety
Description
Cause of death (cardiac vs. non-cardiac); MI type; stroke type and severity.
Time Frame
1 year
Title
Recurrence of Angina
Description
Analyse patient recurrence of angina according to the Canadian Cardiovascular Society (CCS)
Time Frame
1 year
Title
Medication Impact
Description
Impact of antithrombotic agents and dual antiplatelet therapy in peri-procedural and long-term follow up safety end points.
Time Frame
1 year
Title
Stent Thrombosis
Description
Evaluate stent thrombosis according to the ARC (Academic Research Consortium) criteria
Time Frame
1 year
Title
Bleeding
Description
Hemorrhagic complications according to the BARC (Bleeding Academic Research Consortium) criteria
Time Frame
1 year
Title
Neurological Events
Description
Evaluate neurological complications by clinical tests (physical examination), vascular ultrasound and doppler perfusion measures.
Time Frame
1 year
Title
Graft Patency
Description
Patency of grafts and coronary artery disease at 1 year of follow-up evaluated by angiotomography
Time Frame
1 year
Title
Clinical and Angiographic Scores Correlation with Prognostic
Description
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
Time Frame
1 year
Title
Efficacy of the Strategy
Description
Evaluate and compare the rate of repeated revascularization (target lesions and target vessels) in each one of both strategies.
Time Frame
1 year
Title
Symptomatic Graft Occlusion
Description
Evaluate patients that presented with recurrent ischaemia symptoms due to graft occlusion. The diagnostic must be done by angiography or angiotomography.
Time Frame
1 Year
Other Pre-specified Outcome Measures:
Title
Quality of life.
Time Frame
5 years
Title
Cost
Description
Evaluate and compare the final cost of the procedure and follow up period of the patients enrolled in each one of the strategies.
Time Frame
5 years
Title
Hospital Stay
Description
Evaluate and compare the period of hospital stay of the patients enrolled in each one of the strategies.
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Facility Information:
Facility Name
InCor -Faculdade de Medicina da Universidade de São Paulo
City
São Paulo
State/Province
SP
ZIP/Postal Code
05403000
Country
Brazil

12. IPD Sharing Statement

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

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