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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
Off-pump LIMA connected to the left anterior descending artery followed by percutaneous coronary intervention with drug eluting stents to the other territories.
On pump coronary artery by-pass surgery
InCor -Faculdade de Medicina da Universidade de São Paulo
São Paulo, São Paulo, Brazil
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.
Time frame: 30 days
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 5 years
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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.
Time frame: 180 days
Safety
Cause of death (cardiac vs. non-cardiac); MI type; stroke type and severity.
Time frame: 1 year
Recurrence of Angina
Analyse patient recurrence of angina according to the Canadian Cardiovascular Society (CCS)
Time frame: 1 year
Medication Impact
Impact of antithrombotic agents and dual antiplatelet therapy in peri-procedural and long-term follow up safety end points.
Time frame: 1 year
Stent Thrombosis
Evaluate stent thrombosis according to the ARC (Academic Research Consortium) criteria
Time frame: 1 year
Bleeding
Hemorrhagic complications according to the BARC (Bleeding Academic Research Consortium) criteria
Time frame: 1 year
Neurological Events
Evaluate neurological complications by clinical tests (physical examination), vascular ultrasound and doppler perfusion measures.
Time frame: 1 year
Graft Patency
Patency of grafts and coronary artery disease at 1 year of follow-up evaluated by angiotomography
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 1 Year