Clinical trial NCT02226900: Myocardial Hybrid Revascularization Versus Coronary artERy Bypass GraftING for Complex Triple-vessel Disease
Official title: Myocardial Hybrid Revascularization Versus Coronary artERy Bypass GraftING for Complex Triple-vessel Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Multivessel Coronary Artery Disease
Keywords: Multivessel Coronary Artery Disease
Hybrid Revascularization
Lead sponsor: InCor Heart Institute
Sponsor class: OTHER
Collaborators: name: Boston Scientific Corporation
First posted: 2014-08-27
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Feasibility of Revascularization Procedure Proposed by the Heart Team
timeFrame: 30 days
Secondary outcomes:
measure: Major Adverse Cardiovascular Events
timeFrame: 1 year
measure: Major Adverse Cardiovascular Events
timeFrame: 2 years
measure: Major Adverse Cardiovascular Events
timeFrame: 3 years
measure: Major Adverse Cardiovascular Events
timeFrame: 4 years
measure: Major Adverse Cardiovascular Events
timeFrame: 5 years
measure: Major Adverse Cardiovascular Events
timeFrame: 180 days
measure: Safety
timeFrame: 1 year
measure: Recurrence of Angina
timeFrame: 1 year
measure: Medication Impact
timeFrame: 1 year
measure: Stent Thrombosis
timeFrame: 1 year
measure: Bleeding
timeFrame: 1 year
measure: Neurological Events
timeFrame: 1 year
measure: Graft Patency
timeFrame: 1 year
measure: Clinical and Angiographic Scores Correlation with Prognostic
timeFrame: 1 year
measure: Efficacy of the Strategy
timeFrame: 1 year
measure: Symptomatic Graft Occlusion
timeFrame: 1 Year
Other outcomes:
measure: Quality of life.
timeFrame: 5 years
measure: Cost
timeFrame: 5 years
measure: Hospital Stay
timeFrame: 1 year
Locations:
city: São Paulo
country: Brazil
facility: InCor -Faculdade de Medicina da Universidade de São Paulo
state: SP
Study officials:
References: