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