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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

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
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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.
No text entered.

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

Baseline Measures
   CABG   PCI With DES   Total 
Overall Participants Analyzed 
[Units: Participants]
 897   903   1800 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   400   397   797 
>=65 years   497   506   1003 
Age 
[Units: Years]
Mean (Standard Deviation)
 64.96  (9.79)   65.23  (9.66)   65.09  (9.72) 
Gender 
[Units: Participants]
     
Female   189   213   402 
Male   708   690   1398 
Region of Enrollment 
[Units: Participants]
     
United States   122   123   245 
Portugal   7   6   13 
Finland   12   12   24 
Spain   26   27   53 
Austria   24   28   52 
United Kingdom   132   135   267 
Italy   96   101   197 
France   105   103   208 
Hungary   39   44   83 
Czech Republic   20   20   40 
Poland   33   33   66 
Belgium   47   44   91 
Denmark   15   17   32 
Norway   4   4   8 
Latvia   20   20   40 
Netherlands   74   74   148 
Germany   93   86   179 
Sweden   28   26   54 
Angina [1] 
[Units: Participants]
     
Participants with Stable Angina at Baseline   513   514   1027 
Participants with Unstable Angina at Baseline   251   261   512 
Participants with Silent Ischemia at Baseline   74   74   148 
Participants with No Angina at Baseline   59   54   113 
[1] number of particpiants with stable, unstable, or no angina at baseline
Bifurcation lesion (per participant) [1] 
[Units: Participants]
     
One or more Bifurcated Lesion(s)   652   649   1301 
No Bifurcated Lesions   245   254   499 
[1] Number of participants with at least one bifurcation lesion as determined by the angiographic core laboratory on the baseline angiogram
Blood pressure ≥130/85 mmHg [1] 
[Units: Participants]
     
Blood Pressure >= 130/85 mmHG   574   622   1196 
Blood Pressure <130/85 mmHG   323   281   604 
[1] number of participants with blood pressure equal or higher than 130/85mmHg
Carotid artery disease [1] 
[Units: Participants]
     
Diagnosed Carotid Artery Disease at Baseline   75   73   148 
No Diagnosed Carotid Artery Disease at Baseline   822   830   1652 
[1] number of particpants with diagnosed carotid artery disease at baseline
Congestive heart failure [1] 
[Units: Participants]
     
Congestive Heart Failure at Baseline   47   36   83 
No Congestive Heart Failure at Baseline   850   867   1717 
[1] number of particpants with congestive heart failure at baseline
Current smoking [1] 
[Units: Participants]
     
Smokers at Baseline   196   167   363 
Non-Smokers at Baseline   701   736   1437 
[1] Number of participants that were smoking at baseline
Diabetes [1] 
[Units: Participants]
     
Diagnosed Diabetes at Baseline   256   255   511 
No Diagnosed Diabetes at Baseline   641   648   1289 
[1] All participants with diagnosed diabetes at baseline
HDL cholesterol (<40 Male or <50 Female) [1] 
[Units: Participants]
     
Participant HDL Less Than Limit at Baseline   404   379   783 
Participant HDL Greater Than Limit at Baseline   493   524   1017 
[1] number of male participants with a high-density lipoprotein (HDL)<40 and female particpants with a HDL<50 determined by the central chemistry laboratory
Hyperlipidemia [1] 
[Units: Participants]
     
Participants with Hyperlipidemia at Baseline   686   705   1391 
Participants without Hyperlipidemia at Baseline   211   198   409 
[1] participants with hyperlipidemia at baseline
Insulin requiring diabetes [1] 
[Units: Participants]
     
Participants with Insulin dependent Diabetes   93   89   182 
Participants with non-Insulin independent Diabetes   163   166   329 
Nondiabetic Participants   641   648   1289 
[1] Number of participants with diabetes treated with insulin
Medically treated Diabetes [1] 
[Units: Participants]
     
Diabetic Participants Medically Treated   221   231   452 
Diabetic Participants Treated through Diet only   35   24   59 
Non-Diabetic Participants   641   648   1289 
[1] Number of participants with medically treated diabetes.Excludes participants with diabetes treated with diet only.
Metabolic Syndrome [1] 
[Units: Participants]
     
Participants with a Metabolic Syndrome   317   339   656 
Participants without a Metabolic Syndrome   580   564   1144 
[1] number of participants that met the criteria of metabolic syndrome defined by the American Heart Association
Poor LVEF [1] 
[Units: Participants]
     
LVEF <30% at Baseline   22   12   34 
LVEF >=30% at Baseline   875   891   1766 
[1] number of participants with left ventricular ejection fraction <30% at baseline
Prior MI [1] 
[Units: Participants]
     
Myocardial Infarction Before Baseline   300   285   585 
No Myocardial Infarction Before Baseline   597   618   1215 
[1] Number of participants who had a myocardial infarction before baseline
Prior Stroke [1] 
[Units: Participants]
     
Stroke Prior to Baseline   43   35   78 
No Stroke Prior to Baseline   854   868   1722 
[1] number of participants who had a stroke before baseline
Prior TIA [1] 
[Units: Participants]
     
Transient Ischemic Attack Before Baseline   45   39   84 
No Transient Ischemic Attack before baseline   852   864   1716 
[1] number of partipants who had a Transient Ischemic Attack before baseline
Total Occlusion (per patient) [1] 
[Units: Participants]
     
Participants with at least One Total Occlusion   198   217   415 
Participants with Partial Occlusion(s)   699   686   1385 
[1] Number of participants with at least one total occlusion as determined by the angiografic core laboratory on the baseline angiogram
Triglyceride levels ≥150 mg/dL [1] 
[Units: Participants]
     
Participants with Triglyceride Levels >= 150 mg/dL   304   275   579 
Participants with Triglyceride Levels <150 mg/dL   593   628   1221 
[1] participants with Triglyceride levels ≥150 mg/dL as determined by a central chemistry laboratorium at baseline
Additive Euroscore [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
 3.79  (2.69)   3.75  (2.62)   3.77  (2.66) 
[1] Additive EuroSCORE is a prognostic scoring system calculating predicted operative mortality for patients undergoing cardiac surgery; it has been the most rigorously evaluated scoring system in cardiac surgery. A predetermined weighted score is assigned for specified patient-, cardiac-, and operation-related factors; for example, pulmonary hypertension is assigned a score of 2. The sum of scores is the additive EuroSCORE. EuroSCORE is calculated from site reported baseline data. A score of greater than 6 is considered as being predictive of an increased mortality risk. (www.euroscore.org)
Body Mass Index (BMI) [1] 
[Units: Kg/m2]
Mean (Standard Deviation)
 27.91  (4.54)   28.11  (4.80)   28.01  (4.67) 
[1] Body Mass Index calculated from participants heigth and weight.
Number of lesions per partipant [1] 
[Units: Number of lesions/Participant]
Mean (Standard Deviation)
 3.99  (1.7)   3.94  (1.66)   3.97  (1.68) 
[1] Average number of lesions per participant as determined by the investigator
Parsonnet Score [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
 8.43  (6.84)   8.53  (6.95)   8.48  (6.9) 
[1] The first scoring system in cardiac surgery to calculate mortality risk and to become popular was the Parsonnet risk stratification system, which was developed in the United States in the 1980s. A predetermined weighted score is assigned for several specified patient-, cardiac-, and operation-related factors; for example, dialysis is assigned a score of 10. A score of greater than 15 is considered as being predictive of an increased mortality risk. Parsonette score is calculated from baseline information.
Total Syntax Score [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
 29.1  (11.37)   28.39  (11.46)   28.7  (11.42) 
[1] The SYNTAX score characterizes the coronary vasculature. It combines the importance of a diseased coronary artery segment (Leaman score), adverse characteristics of a lesion (ACC/AHA lesion classification) and the modified Duke/ICPS classification for bifurcation lesions. Higher SYNTAX scores are indicative of more complex lesions and disease; thus higher scores would predict worse short-term outcomes. Calculated from angiographic corelab analysis of baseline angiogram. (www.syntaxscore.com)


  Outcome Measures
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1.  Primary:   Primary Clinical Endpoint of 12-Month Binary MACCE.   [ Time Frame: 12 months post enrollment ]
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Measure Type Primary
Measure Title Primary Clinical Endpoint of 12-Month Binary MACCE.
Measure Description 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).
Time Frame 12 months post enrollment  
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. Number of participants analyzed equals number of subjects who completed Overall Study, as listed in Participant Flow.

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 
Participants Analyzed 
[Units: Participants]
 849   891 
Primary Clinical Endpoint of 12-Month Binary MACCE. 
[Units: Participants]
 105   159 

No statistical analysis provided for Primary Clinical Endpoint of 12-Month Binary MACCE.



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 ]

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 reported.   Anticipated Reporting 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 reported.   Anticipated Reporting 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 reported.   Anticipated Reporting 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 reported.   Anticipated Reporting 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 reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   Yes


  Serious Adverse Events


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