MIDCAB Versus DES in Proximal LAD Lesions

Study Overview
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Brief Summary
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Percutaneous coronary intervention with a sirolimus-coated stent compared to minimally invasive bypass surgery in patients with isolated proximal left anterior descending coronary arteries in terms of non-inferiority of an end point combining mortality, acute myocardial infarction and rate of reintervention of the target vessel within one year.

Official Title
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Randomised Comparison of Minimally Invasive Direct Coronary Artery Bypass Grafting and Percutaneous Coronary Intervention With Drug-eluting Stents in Patients With Proximal Stenosis of the Left Anterior Descending Coronary Artery

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Procedure: Stenting and minimally invasive bypass surgery
* Procedure: PCI with DES


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Single-vessel disease of the proximal LAD with a stenosis > 50% (multivessel disease only if further coronary vessel stenoses do not require treatment) Patients with angina pectoris (CCS 1-4) Asymptomatic patients if clear signs of ischemia in the segments supplied by the LAD as assessed by bicycle ergometry or treadmill and/or scintigraphically and/or stress echo Patients for whom both methods of treatment are equally possible Consensus between the cardiac surgeon and the cardiologist that both inclusion and exclusion criteria are met in the selected case Informed consent of the patient. Exclusion Criteria: Patients < 18 years Pregnancy Previous coronary artery bypass surgery Concomitant diseases that lead to a greater risk for each of the treatment strategies Significant peripheral arterial occlusive disease Concomitant disease with limited life expectancy (e.g. malignant tumours that have not been curatively treated) Objective follow-up examination not possible due to physical or mental handicap Participation in another study. Angiographical exclusion criteria: Left main stem stenosis Multivessel disease for which surgical or interventional therapy on other vessel areas is required. Diagonal/septal branch > 1.5 mm, which might be compromised by a stent Need for acute intervention (e.g. acute myocardial infarction) Total occlusion of the LAD

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 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: MIDCAB Surgery<br>MIDCAB Surgery | Procedure: Stenting and minimally invasive bypass surgery<br> <br> |
| Experimental: PCI with drug-eluting stent<br>PCI with DES | Procedure: PCI with DES<br>* PCI with DES<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major adverse cardiac events |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Perioperative complications |  | 30 days | 
| CCS-Classification |  | 12 months | 
| cost-effectiveness |  | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stent, drug-eluting stent, Minimally invasive bypass surgery, left anterior descending