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

Boston Scientific

Status and phase

Unknown

Phase 3

Conditions

Coronary Artery Disease

Treatments

Procedure: Coronary Artery Bypass Surgery

Device: Polymer-based Paclitaxel-Eluting TAXUS Express2-SR Stent

Study type

Interventional

Funder types

Industry

Identifiers

NCT00114972

S2024

90169394

Details and patient eligibility

About

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).

Full 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.

Enrollment

1,800 patients

Sex

All

Ages

21+ years old

Volunteers

No Healthy Volunteers

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