ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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 Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (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


  Baseline Characteristics

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

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

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

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

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 ]
  Show Outcome Measure 4

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

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

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

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

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.  

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.  

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.  

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.  

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.  


  Serious Adverse Events


  Other Adverse Events

Time Frame 1 year
Additional Description No text entered.

Frequency Threshold
Threshold above which other adverse events are reported   5%  

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

Other Adverse Events
    CABG   PCI With DES
Total, Other (not including serious) Adverse Events     
# participants affected / at risk   509/897 (56.74%)   405/903 (44.85%) 
Blood and lymphatic system disorders     
Anaemia * 1     
# participants affected / at risk   104/897 (11.59%)   23/903 (2.55%) 
# events   109   24 
Cardiac disorders     
Angina pectoris * 1     
# participants affected / at risk   26/897 (2.90%)   61/903 (6.76%) 
# events   28   70 
Atrial fibrillation * 1     
# participants affected / at risk   123/897 (13.71%)   25/903 (2.77%) 
# events   129   28 
General disorders     
All other Adverse Events * 1 [3]     
# participants affected / at risk   509/897 (56.74%)   405/903 (44.85%) 
# events   1099   854 
Infections and infestations     
Wound infection * 1     
# participants affected / at risk   56/897 (6.24%)   2/903 (0.22%) 
# events   58   2 
Injury, poisoning and procedural complications     
Incision site complication * 1     
# participants affected / at risk   47/897 (5.24%)   3/903 (0.33%) 
# events   52   3 
Respiratory, thoracic and mediastinal disorders     
Pleural effusion * 1     
# participants affected / at risk   54/897 (6.02%)   2/903 (0.22%) 
# events   55   2 
* Events were collected by non-systematic assessment
1 Term from vocabulary, MedDRA (8.0)
[3] Total of all other adverse events with an occurrence below the 5% treshold.



  Limitations and Caveats

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
No text entered.


  More Information