Long-term Comparison of Stenting Versus Off-pump Coronary Bypass Surgery

Study Overview
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Brief Summary
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The randomized comparison of two strategies in coronary revascularization: bypass surgery without the use of a heart lung machine and coronary stenting procedure. The comparison comprised the occurrence of cardiac adverse events after the procedure. In addition, costs, cognitive outcomes and angiography were assessed.

Detailed Description
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Coronary artery bypass surgery with use of the heart lung machine (on-pump surgery), is associated with the risk of peri-operative complications such as death, stroke, myocardial infarction, neurocognitive decline, and extended hospitalization. Bypass surgery on the beating heart without the use of the heart lung machine (off-pump surgery) has been reintroduced in clinical practice in order to reduce these complications. The Octopus cardiac wall stabilizer, developed at the UMC Utrecht, facilitates the safe construction of the grafts during the off-pump procedure. The expected advantages of off-pump surgery e.g. less-invasiveness, complete arterial revascularization, faster recovery and lower costs were the basis for the Octostent trial. We hypothesized that the off-pump surgical technique might offer an alternative for angioplasty with bare-metal stent-implantation. The current study was designed as a randomized controlled multicenter trial comparing two strategies.

Official Title
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A Randomized Comparison of Long-term Clinical , Neurocognitive, Angiographical and Health-costs, After Stenting Versus Off-pump Coronary Bypass Surgery in Patients With Symptomatic Coronary Artery Disease

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Procedure: Coronary Revascularization


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients with coronary artery disease referred for PCI in which both Off Pump Coronary Bypass surgery and PCI were deemed technically feasible Exclusion Criteria: a history of CABG or stenting emergency or concomitant major surgery Q-wave myocardial infarction in the last six weeks inability to give informed consent

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Percutaneous Coronary Intervention<br> | Procedure: Coronary Revascularization<br>* revascularization of coronary arteries in case of symptomatic obstructive coronary artery disease<br>* Other names: MICAB;|
| Experimental: Off Pump Coronary Artery Bypass Surgery<br> | Procedure: Coronary Revascularization<br>* revascularization of coronary arteries in case of symptomatic obstructive coronary artery disease<br>* Other names: MICAB;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major Adverse Cardiac Events |  | 7.5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life |  | 7.5 years | 
| Neurocognitive outcome |  | 7.5 years | 
| Cost effectiveness |  | 7.5 years | 
| Angiographical patency of revascularization |  | 7.5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Symptomatic Coronary Artery Disease Patients