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

Phase 3

Conditions: Coronary Artery Disease

Registration Number: NCT00114972

Lead Sponsor: Boston Scientific Corporation

Brief Summary: 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: 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.

Recruitment & Eligibility

Status: UNKNOWN

Sex: All

Target Recruitment: 1800

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Primary Clinical Endpoint of 12-Month Binary MACCE.	12 months post enrollment	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-month Composite Safety Endpoint.	12 months after enrollment	Number of participants at 12-month composite safety endpoint. Composite safety endpoint combines: all cause death, cerebrovascular event (stroke), and documented myocardial infarction.
Repeat Revascularization (PCI and/or CABG).	12 Months post enrollment	Number of participants with repeat revascularization (PCI and/or CABG).

Secondary Outcome Measures

Name	Time	Method
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	Number of participants with Overall MACCE at 1 month post-procedure and at 6 months, 3 years, and 5 years post-allocation.
Individual Components of MACCE at 1 Month Post-procedure.	1 month after 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.
Individual Components of MACCE at 6 Months Post-allocation.	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.
Individual Components of MACCE at 1 Year Post-allocation.	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.
Freedom From MACCE and Its Components at 1 Year Post-allocation.	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).
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

Trial Locations

Locations (106): Mercy General Hospital
🇺🇸
Sacramento, California, United States
Washington Hospital Center
🇺🇸
Washington, 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
Scroll for more (96 remaining)
Mercy General Hospital
🇺🇸Sacramento, California, United States