SYNTAX Study: TAXUS Drug-Eluting Stent Versus Coronary Artery Bypass Surgery for the Treatment of Narrowed Arteries

Study Overview
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Brief Summary
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The SYNTAX trial is designed to determine the best treatment for patients with complex coronary disease (blocked or narrowed arteries in both the right and left sides of the heart) by randomizing patients to receive either percutaneous coronary intervention (PCI) with polymer-based paclitaxel-eluting TAXUS stents or to coronary artery bypass surgery (CABG).

Detailed Description
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Due to the introduction of drug-eluting stents (DESs) and to improvements in therapy for both percutaneous coronary intervention (PCI) and coronary artery bypass surgery (CABG) patients, PCI is challenging CABG as the gold standard for treatment of three vessel (3VD) and left main (LM) coronary disease. SYNTAX is a novel, randomized trial with nested registries comparing PCI with paclitaxel-eluting TAXUS stents to CABG for 3VD and LM patients to evaluate the best treatment for these patients with complex coronary disease. Patients at participating centers will be evaluated by both a cardiothoracic surgeon and by an interventional cardiologist. Those patients who are determined to be eligible for treatment by both PCI and CABG will be randomized to receive either PCI with a polymer-based paclitaxel-eluting TAXUS stent or CABG. Patients who are determined to be unsuitable for treatment by PCI will be treated by CABG and will be entered into a CABG registry to help define the patient population in which stenting continues to be an unacceptable treatment option. Similarly, patients who are determined to be unsuitable for treatment by CABG will be treated by PCI, using any interventional techniques or devices with or without the use of DES, and entered into a PCI registry to help define the patients for whom CABG is considered inappropriate.

Official Title
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SYNTAX Study: SYNergy Between PCI With TAXUS and Cardiac Surgery

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Device: Polymer-based Paclitaxel-Eluting TAXUS Express2-SR Stent
* Procedure: Coronary Artery Bypass Surgery


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Three-vessel disease, left main disease or LM equivalent with or without 1, 2 or 3VD (left anterior descending [LAD], left circumflex [LCX], right coronary artery [RCA] territory) De novo lesions with at least 50% stenosis Myocardial ischemia (stable, unstable, silent) Exclusion Criteria: Prior PCI or CABG Acute myocardial infarction (with creatinine kinase >2x upper limit of normal) Concomitant cardiac valve disease requiring surgical therapy (reconstruction or replacement) Participation or planned participation in another cardiovascular clinical study before 1 year follow-up is completed Inability to give informed consent due to mental condition, mental retardation, or language barrier

Ages Eligible for Study
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Minimum Age: 21 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 |
| --- | --- |
| Experimental: PCI with DES<br> | Device: Polymer-based Paclitaxel-Eluting TAXUS Express2-SR Stent<br>* Drug Eluting Stent<br>* Other names: Left main stem;|
| Active Comparator: CABG (coronary artery bypass graft)<br>Coronary Artery Bypass Graft | Procedure: Coronary Artery Bypass Surgery<br>* Coronary Artery Bypass Surgery<br>* Other names: Left Main coronary artery;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary Clinical Endpoint of 12-Month Binary MACCE. | Number of participants at primary clinical endpoint of 12-Month binary MACCE. MACCE is defined as: all cause death, cerebrovascular event (stroke), cocumented myocardial infarction, repeat revascularization (PCI and/or CABG). | 12 months post enrollment | 
| 12-month Composite Safety Endpoint. | Number of participants at 12-month composite safety endpoint. Composite safety endpoint combines: all cause death, cerebrovascular event (stroke), and documented myocardial infarction. | 12 months after enrollment | 
| Repeat Revascularization (PCI and/or CABG). | Number of participants with repeat revascularization (PCI and/or CABG). | 12 Months post enrollment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall MACCE at 1 Month Post-procedure and at 6 Months, 3 Years, and 5 Years Post-allocation. | Number of participants with Overall MACCE at 1 month post-procedure and at 6 months, 3 years, and 5 years post-allocation. | 1 month after procedure and 6 months, 3 years, and 5 years post allocation | 
| Individual Components of MACCE at 1 Month Post-procedure. | Number of participants with individual components of MACCE at 1 month post-procedure. The individual components of MACCE are: all cause death, stroke, documented myocardial infarction, repeat revascularization. | 1 month after procedure | 
| Individual Components of MACCE at 6 Months Post-allocation. | Number of participants with individual components of MACCE at 6 months post-allocation. The individual components of MACCE are: all cause death, stroke, documented myocardial infarction, repeat revascularization. | 6 months post allocation | 
| Individual Components of MACCE at 1 Year Post-allocation. | Number of participants with individual components of MACCE at 1 year post-allocation. The individual components of MACCE are: all cause death, stroke, documented myocardial infarction, repeat revascularization. | 1 year post allocation | 
| Freedom From MACCE and Its Components at 1 Year Post-allocation. | Number of participants with freedom from MACCE and its components at 1 year post-allocation. Freedom from MACCE is defined as no MACCE nor any of the individual components of MACCE (all cause death, stroke, documented myocardial infarction, repeat revascularization). | 1 year post allocation | 
| Freedom From MACCE and Its Components at 3 Years Post-allocation |  | 3 years post allocation | 
| Freedom From MACCE and Its Components at 5 Years Post-allocation |  | 5 years post allocation | 
| Quality of Life at 1 Month Post-procedure and at 6 Months, 1, 3 and 5 Years Post-allocation |  | 1 month after procedure and 6 months, 1, 3 and 5 years post allocation | 
| Cost and Cost-effectiveness at 1, 3 and 5 Years Post-allocation |  | 1 year, 3 and 5 years post allocation | 
| The Characteristics (Including Co-morbidity and Coronary Vascular Lesion Complexity Scoring Referred to as the SYNTAX Score) of the Following: PCI Versus CABG Randomized Cohort, PCI Registry Cohort (CABG Ineligible), CABG Registry Cohort (PCI Ineligible) |  | 5 Years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Three-vessel coronary artery disease, Left main coronary artery disease