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| Name | Class |
|---|---|
| Boston Scientific Corporation | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hybrid Revascularization | Experimental | 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. |
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| Conventional Surgical Coronary Bypass Grafting | Other | Conventional Coronary Artery Bypass Grafts with in pump technique. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hybrid Revascularization | Procedure | Off-pump LIMA connected to the left anterior descending artery followed by percutaneous coronary intervention with drug eluting stents to the other territories. |
| 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 |
| 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 |
| 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 |
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
Silent ischemia, stable angina, unstable angina or recent MI
Ability to sign informed consent and comply with all study procedures
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| InCor -Faculdade de Medicina da Universidade de São Paulo | São Paulo | São Paulo | 05403000 | Brazil |
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| ID | Term |
|---|---|
| D013514 | Surgical Procedures, Operative |
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| Conventional Coronary Artery Bypass Surgery | Procedure | On pump coronary artery by-pass surgery |
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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 |
| Hospital Stay | Evaluate and compare the period of hospital stay of the patients enrolled in each one of the strategies. | 1 year |