SMART Trial Longitudinal Follow-Up:Off-Pump Versus On-Pump Coronary Artery Bypass Surgery

Study Overview
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Brief Summary
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The purpose of this study is to determine completeness of revascularization, graft patency, clinical outcomes, health-related quality of life and costs in 200 initial trial participants at > 5 years post surgery who had heart bypass surgery with heart-lung bypass (on-pump) or without heart-lung bypass (off-pump). The hypothesis is that the patency of coronary artery bypass grafts of off-pump surgery are no less durable than grafts from conventional on-pump surgery.

Detailed Description
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The Surgical Management of Arterial Revascularization Therapies (SMART) trial is a randomized, controlled, double blinded trial designed to compare completeness of revascularization, graft patency, clinical outcomes, health-related quality of life and costs in 200 unselected patients referred for elective, isolated coronary bypass surgery and randomized to have coronary artery bypass performed with or without cardiopulmonary bypass. These patients were enrolled between March 2000 to August 2001. The primary objective of this study is to test the hypothesis that the patency of coronary artery bypass grafts constructed during off-pump coronary artery bypass (OPCAB)are no less durable than the patency of those constructed during conventional CABG with cardiopulmonary bypass (CABG/CPB)after > 5 years of follow-up (non-inferiority hypothesis). The secondary objectives are to determine whether there are differences between these randomized groups in the following outcomes measures at > 5 years: Neurocognitive Function Stroke/cerebral injury Health-related quality of life Myocardial perfusion and ischemia Major Adverse Cardiac Events (MACE) Cardiac Functional Status Incidence and severity of angina All cause mortality and cardiovascular mortality Cost of hospital re-admissions since 1 year follow-up

Official Title
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A Prospective, Randomized Comparison of Graft Patency and Clinical Outcomes After Coronary Bypass Surgery Performed With and Without the Use of Cardiopulmonary Bypass:Longitudinal Follow-Up

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Procedure: Coronary Artery Bypass


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Referred for primary or re-operative elective coronary artery bypass graft (CABG) with coronary targets suitable for off-pump bypass graft and currently enrolled in Phase 1 of SMART Trial Exclusion Criteria: Emergent CABG Required pre-operative intra-aortic balloon pump (IABP) Cardiogenic shock Evolving acute myocardial infarction Coronary artery targets unsuitable for off-pump bypass surgery Inability or unwillingness to provide informed consent

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Off Pump CABG<br>CABG without cardiopulmonary bypass. | Procedure: Coronary Artery Bypass<br> <br> |
| Active Comparator: On-Pump CABG<br>CABG with cardiopulmonary bypass. | Procedure: Coronary Artery Bypass<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| after > 5 years, graft patency determined by non-invasive dual 64 slice multi-detector computed tomographic coronary angiography and cardiac positron emission tomography. |  | 8 year follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secondary outcomes will be measured by; a battery of neuropsychological tests, MRI, NIH stroke scale, questionnaires, cardiac PET scanning, NYHA and CCS classifications and Medicare DRG's. |  | 8 year follow-up |