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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2010 by Boston Scientific Corporation.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Cardialysis BV
Information provided by:
Boston Scientific Corporation
ClinicalTrials.gov Identifier:
NCT00114972
First received: June 20, 2005
Last updated: May 27, 2010
Last verified: May 2010
Results First Received: March 27, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Coronary Artery Disease
Interventions: Device: Polymer-based Paclitaxel-Eluting TAXUS Express2-SR Stent
Procedure: Coronary Artery Bypass Surgery

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
CABG Coronary Artery By-pass Graft (CABG)
PCI With DES Percutaneous coronary intervention (PCI) using TAXUS Express Drug Eluting Stent (DES)

Participant Flow:   Overall Study
    CABG     PCI With DES  
STARTED     897     903  
COMPLETED     849     891  
NOT COMPLETED     48     12  
Withdrawal by Subject                 40                 7  
Lost to Follow-up                 8                 5  



  Baseline Characteristics


  Outcome Measures
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1.  Primary:   Primary Clinical Endpoint of 12-Month Binary MACCE.   [ Time Frame: 12 months post enrollment ]

2.  Primary:   12-month Composite Safety Endpoint.   [ Time Frame: 12 months after enrollment ]

3.  Primary:   Repeat Revascularization (PCI and/or CABG).   [ Time Frame: 12 Months post enrollment ]

4.  Secondary:   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 ]

5.  Secondary:   Individual Components of MACCE at 1 Month Post-procedure.   [ Time Frame: 1 month after procedure ]

6.  Secondary:   Individual Components of MACCE at 6 Months Post-allocation.   [ Time Frame: 6 months post allocation ]

7.  Secondary:   Individual Components of MACCE at 1 Year Post-allocation.   [ Time Frame: 1 year post allocation ]
  Hide Outcome Measure 7

Measure Type Secondary
Measure Title Individual Components of MACCE at 1 Year Post-allocation.
Measure Description 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.
Time Frame 1 year post allocation  
Safety Issue Yes  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
ITT analysis

Reporting Groups
  Description
CABG Coronary Artery By-pass Graft (CABG)
PCI With DES Percutaneous coronary intervention (PCI) using TAXUS Express Drug Eluting Stent (DES)

Measured Values
    CABG     PCI With DES  
Number of Participants Analyzed  
[units: participants]
  849     891  
Individual Components of MACCE at 1 Year Post-allocation.  
[units: participants]
   
Death any cause     30     39  
Stroke     19     5  
Documented MI     28     43  
Any repeat revascularization     50     120  

No statistical analysis provided for Individual Components of MACCE at 1 Year Post-allocation.



8.  Secondary:   Freedom From MACCE and Its Components at 1 Year Post-allocation.   [ Time Frame: 1 year post allocation ]

9.  Secondary:   Freedom From MACCE and Its Components at 3 Years Post-allocation   [ Time Frame: 3 years post allocation ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   Yes

10.  Secondary:   Freedom From MACCE and Its Components at 5 Years Post-allocation   [ Time Frame: 5 years post allocation ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   Yes

11.  Secondary:   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 ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

12.  Secondary:   Cost and Cost-effectiveness at 1, 3 and 5 Years Post-allocation   [ Time Frame: 1 year, 3 and 5 years post allocation ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

13.  Secondary:   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 ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   Yes


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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