NCT00114972

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

SYNTAX Study: SYNergy Between PCI With TAXUS and Cardiac Surgery

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,800 (actual)
• Sponsor: Boston Scientific Corporation · Industry
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Coronary Artery Disease

Interventions

Type	Name	Description
DEVICE	Polymer-based Paclitaxel-Eluting TAXUS Express2-SR Stent	Drug Eluting Stent
PROCEDURE	Coronary Artery Bypass Surgery	Coronary Artery Bypass Surgery

Timeline

• Start date: 2005-03-01
• Primary completion: 2008-04-01
• Completion: 2012-05-01
• First posted: 2005-06-21
• Last updated: 2010-06-23
• Results posted: 2010-06-23

Locations

106 sites across 18 countries: United States, Austria, Belgium, Czechia, Denmark, Finland, France, Germany, Hungary, Italy, Latvia, Netherlands, Norway, Poland, Portugal, Spain, Sweden, United Kingdom