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

Multivessel Coronary Artery Disease Clinical Trial

— MERGING  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02226900
• Other study ID #: MERGING
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 2014

Study information

• Verified date: November 2018
• Source: InCor Heart Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. primary completion date: December 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Multivessel Coronary Artery Disease
• Myocardial Ischemia

Intervention

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.
• Conventional Coronary Artery Bypass Surgery
On pump coronary artery by-pass surgery

Locations

Country	Name	City	State
Brazil	InCor -Faculdade de Medicina da Universidade de São Paulo	São Paulo	SP

Sponsors (2)

Lead Sponsor	Collaborator
InCor Heart Institute	Boston Scientific Corporation

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Quality of life.		5 years
Other	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
Other	Hospital Stay	Evaluate and compare the period of hospital stay of the patients enrolled in each one of the strategies.	1 year
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Safety	Cause of death (cardiac vs. non-cardiac); MI type; stroke type and severity.	1 year
Secondary	Recurrence of Angina	Analyse patient recurrence of angina according to the Canadian Cardiovascular Society (CCS)	1 year
Secondary	Medication Impact	Impact of antithrombotic agents and dual antiplatelet therapy in peri-procedural and long-term follow up safety end points.	1 year
Secondary	Stent Thrombosis	Evaluate stent thrombosis according to the ARC (Academic Research Consortium) criteria	1 year
Secondary	Bleeding	Hemorrhagic complications according to the BARC (Bleeding Academic Research Consortium) criteria	1 year
Secondary	Neurological Events	Evaluate neurological complications by clinical tests (physical examination), vascular ultrasound and doppler perfusion measures.	1 year
Secondary	Graft Patency	Patency of grafts and coronary artery disease at 1 year of follow-up evaluated by angiotomography	1 year
Secondary	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
Secondary	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
Secondary	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