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

Sponsor:	Boston Scientific Corporation
Collaborator:	Cardialysis BV
Information provided by:	Boston Scientific Corporation
ClinicalTrials.gov Identifier:	NCT00114972

Purpose

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).

Condition	Intervention	Phase
Coronary Artery Disease	Device: Polymer-based Paclitaxel-Eluting TAXUS Express2-SR Stent Procedure: Coronary Artery Bypass Surgery	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	SYNTAX Study: SYNergy Between PCI With TAXUS and Cardiac Surgery

Resource links provided by NLM:

MedlinePlus related topics: Coronary Artery Bypass Surgery Coronary Artery Disease

Drug Information available for: Paclitaxel

U.S. FDA Resources

Further study details as provided by Boston Scientific Corporation:

Primary Outcome Measures:

Primary Clinical Endpoint of 12-Month Binary MACCE. [ Time Frame: 12 months post enrollment ] [ Designated as safety issue: Yes ]
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. [ Time Frame: 12 months after enrollment ] [ Designated as safety issue: Yes ]
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). [ Time Frame: 12 Months post enrollment ] [ Designated as safety issue: Yes ]
Number of participants with repeat revascularization (PCI and/or CABG).

Secondary Outcome Measures:

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 ] [ Designated as safety issue: Yes ]
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. [ Time Frame: 1 month after procedure ] [ Designated as safety issue: Yes ]
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. [ Time Frame: 6 months post allocation ] [ Designated as safety issue: Yes ]
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. [ Time Frame: 1 year post allocation ] [ Designated as safety issue: Yes ]
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. [ Time Frame: 1 year post allocation ] [ Designated as safety issue: Yes ]
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 [ Time Frame: 3 years post allocation ] [ Designated as safety issue: Yes ]
Freedom From MACCE and Its Components at 5 Years Post-allocation [ Time Frame: 5 years post allocation ] [ Designated as safety issue: Yes ]
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 ] [ Designated as safety issue: No ]
Cost and Cost-effectiveness at 1, 3 and 5 Years Post-allocation [ Time Frame: 1 year, 3 and 5 years post allocation ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: Yes ]

Enrollment:	1800
Study Start Date:	March 2005
Estimated Study Completion Date:	May 2012
Primary Completion Date:	April 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: PCI with DES	Device: Polymer-based Paclitaxel-Eluting TAXUS Express2-SR Stent Drug Eluting Stent Other Names: Percutaneous coronary intervention Paclitaxel eluting stent 3 vessel disease Left main stem
Active Comparator: CABG (coronary artery bypass graft) Coronary Artery Bypass Graft	Procedure: Coronary Artery Bypass Surgery Coronary Artery Bypass Surgery Other Names: Coronary artery disease Coronary artery bypass graft Left Main coronary artery

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.

Eligibility

Ages Eligible for Study:	21 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00114972

Show 106 Study Locations

Sponsors and Collaborators

Boston Scientific Corporation

Cardialysis BV

Investigators

Principal Investigator:	Patrick W. Serruys, MD, PhD	Erasmus University Medical Center Rotterdam
Principal Investigator:	Friedrich W Mohr, MD	University of Leipzig
Study Director:	Monika Hanisch, PhD	Boston Scientific Corporation

More Information

No publications provided by Boston Scientific Corporation

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Cohen DJ, Van Hout B, Serruys PW, Mohr FW, Macaya C, den Heijer P, Vrakking MM, Wang K, Mahoney EM, Audi S, Leadley K, Dawkins KD, Kappetein AP; Synergy between PCI with Taxus and Cardiac Surgery Investigators. Quality of life after PCI with drug-eluting stents or coronary-artery bypass surgery. N Engl J Med. 2011 Mar 17;364(11):1016-26.

Mohr FW, Rastan AJ, Serruys PW, Kappetein AP, Holmes DR, Pomar JL, Westaby S, Leadley K, Dawkins KD, Mack MJ. Complex coronary anatomy in coronary artery bypass graft surgery: impact of complex coronary anatomy in modern bypass surgery? Lessons learned from the SYNTAX trial after two years. J Thorac Cardiovasc Surg. 2011 Jan;141(1):130-40.

Morice MC, Serruys PW, Kappetein AP, Feldman TE, Ståhle E, Colombo A, Mack MJ, Holmes DR, Torracca L, van Es GA, Leadley K, Dawkins KD, Mohr F. Outcomes in patients with de novo left main disease treated with either percutaneous coronary intervention using paclitaxel-eluting stents or coronary artery bypass graft treatment in the Synergy Between Percutaneous Coronary Intervention with TAXUS and Cardiac Surgery (SYNTAX) trial. Circulation. 2010 Jun 22;121(24):2645-53. Epub 2010 Jun 7.

Banning AP, Westaby S, Morice MC, Kappetein AP, Mohr FW, Berti S, Glauber M, Kellett MA, Kramer RS, Leadley K, Dawkins KD, Serruys PW. Diabetic and nondiabetic patients with left main and/or 3-vessel coronary artery disease: comparison of outcomes with cardiac surgery and paclitaxel-eluting stents. J Am Coll Cardiol. 2010 Mar 16;55(11):1067-75. Epub 2010 Jan 14.

Serruys PW, Morice MC, Kappetein AP, Colombo A, Holmes DR, Mack MJ, Ståhle E, Feldman TE, van den Brand M, Bass EJ, Van Dyck N, Leadley K, Dawkins KD, Mohr FW; SYNTAX Investigators. Percutaneous coronary intervention versus coronary-artery bypass grafting for severe coronary artery disease. N Engl J Med. 2009 Mar 5;360(10):961-72. Epub 2009 Feb 18.

Responsible Party:	Nic Van Dyck, Boston Scientific
ClinicalTrials.gov Identifier:	NCT00114972 History of Changes
Other Study ID Numbers:	S2024, 90169394
Study First Received:	June 20, 2005
Results First Received:	March 27, 2009
Last Updated:	May 27, 2010
Health Authority:	United States: Food and Drug Administration

Keywords provided by Boston Scientific Corporation:

Three-vessel coronary artery disease
Left main coronary artery disease

Additional relevant MeSH terms:

Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Paclitaxel

Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 09, 2012