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

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ClinicalTrials.gov Identifier: NCT00114972
Recruitment Status : Unknown
Verified May 2010 by Boston Scientific Corporation.
Recruitment status was:  Active, not recruiting
First Posted : June 21, 2005
Results First Posted : June 23, 2010
Last Update Posted : June 23, 2010
Sponsor:
Collaborator:
Cardialysis BV
Information provided by:
Boston Scientific Corporation

Study Description
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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).

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Device: Polymer-based Paclitaxel-Eluting TAXUS Express2-SR Stent Procedure: Coronary Artery Bypass Surgery Phase 3

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1800 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: SYNTAX Study: SYNergy Between PCI With TAXUS and Cardiac Surgery
Study Start Date : March 2005
Actual Primary Completion Date : April 2008
Estimated Study Completion Date : May 2012

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Primary Clinical Endpoint of 12-Month Binary MACCE. [ Time Frame: 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).

  2. 12-month Composite Safety Endpoint. [ Time Frame: 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.

  3. Repeat Revascularization (PCI and/or CABG). [ Time Frame: 12 Months post enrollment ]
    Number of participants with repeat revascularization (PCI and/or CABG).


Secondary Outcome Measures :
  1. 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 ]
    Number of participants with Overall MACCE at 1 month post-procedure and at 6 months, 3 years, and 5 years post-allocation.

  2. Individual Components of MACCE at 1 Month Post-procedure. [ Time Frame: 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.

  3. Individual Components of MACCE at 6 Months Post-allocation. [ Time Frame: 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.

  4. Individual Components of MACCE at 1 Year Post-allocation. [ Time Frame: 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.

  5. Freedom From MACCE and Its Components at 1 Year Post-allocation. [ Time Frame: 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).

  6. Freedom From MACCE and Its Components at 3 Years Post-allocation [ Time Frame: 3 years post allocation ]
  7. Freedom From MACCE and Its Components at 5 Years Post-allocation [ Time Frame: 5 years post allocation ]
  8. 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 ]
  9. Cost and Cost-effectiveness at 1, 3 and 5 Years Post-allocation [ Time Frame: 1 year, 3 and 5 years post allocation ]
  10. 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 ]

Eligibility Criteria
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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00114972


Locations
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Sponsors and Collaborators
Boston Scientific Corporation
Cardialysis BV
Investigators
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Principal Investigator: Patrick W. Serruys, MD, PhD Erasmus Medical Center
Principal Investigator: Friedrich W Mohr, MD Heart Center Leipzig - University Hospital
Study Director: Monika Hanisch, PhD Boston Scientific Corporation
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Nic Van Dyck, Boston Scientific
ClinicalTrials.gov Identifier: NCT00114972    
Other Study ID Numbers: S2024
90169394
First Posted: June 21, 2005    Key Record Dates
Results First Posted: June 23, 2010
Last Update Posted: June 23, 2010
Last Verified: May 2010
Keywords provided by Boston Scientific Corporation:
Three-vessel coronary artery disease
Left main coronary artery disease
Additional relevant MeSH terms:
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Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
 Paclitaxel
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action