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).
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
1,800
Drug Eluting Stent
Coronary Artery Bypass Surgery
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).
Time frame: 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.
Time frame: 12 months after enrollment
Repeat Revascularization (PCI and/or CABG).
Number of participants with repeat revascularization (PCI and/or CABG).
Time frame: 12 Months post enrollment
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.
Time frame: 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.
Time frame: 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.
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Mercy General Hospital
Sacramento, California, United States
Washington Hospital Center
Washington D.C., District of Columbia, United States
Florida Cardiovascular Research
Atlantis, Florida, United States
Munroe Medical Center
Ocala, Florida, United States
Ocala Heart Institue
Ocala, Florida, United States
Florida Hospital
Orlando, Florida, United States
Evanston Hospital
Evanston, Illinois, United States
Rockford Cardiology Research Foundation (St. Anthony's Medical Center)
Rockford, Illinois, United States
University of Iowa Hospital and Clinics
Iowa City, Iowa, United States
Maine Medical Center
Portland, Maine, United States
...and 96 more locations
Time frame: 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.
Time frame: 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).
Time frame: 1 year post allocation
Freedom From MACCE and Its Components at 3 Years Post-allocation
Time frame: 3 years post allocation
Freedom From MACCE and Its Components at 5 Years Post-allocation
Time frame: 5 years post allocation
Quality of Life at 1 Month Post-procedure and at 6 Months, 1, 3 and 5 Years Post-allocation
Time frame: 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
Time frame: 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)
Time frame: 5 Years