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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
History of Changes
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
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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)
Total Total of all reporting groups

Baseline Measures
    CABG     PCI With DES     Total  
Number of Participants  
[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  
Bifurcation lesion (per participant) [2]
[units: participants]
 		     
One or more Bifurcated Lesion(s)     652     649     1301  
No Bifurcated Lesions     245     254     499  
Blood pressure ≥130/85 mmHg [3]
[units: participants]
 		     
Blood Pressure >= 130/85 mmHG     574     622     1196  
Blood Pressure <130/85 mmHG     323     281     604  
Carotid artery disease [4]
[units: participants]
 		     
Diagnosed Carotid Artery Disease at Baseline     75     73     148  
No Diagnosed Carotid Artery Disease at Baseline     822     830     1652  
Congestive heart failure [5]
[units: participants]
 		     
Congestive Heart Failure at Baseline     47     36     83  
No Congestive Heart Failure at Baseline     850     867     1717  
Current smoking [6]
[units: participants]
 		     
Smokers at Baseline     196     167     363  
Non-Smokers at Baseline     701     736     1437  
Diabetes [7]
[units: participants]
 		     
Diagnosed Diabetes at Baseline     256     255     511  
No Diagnosed Diabetes at Baseline     641     648     1289  
HDL cholesterol (<40 Male or <50 Female) [8]
[units: participants]
 		     
Participant HDL Less Than Limit at Baseline     404     379     783  
Participant HDL Greater Than Limit at Baseline     493     524     1017  
Hyperlipidemia [9]
[units: participants]
 		     
Participants with Hyperlipidemia at Baseline     686     705     1391  
Participants without Hyperlipidemia at Baseline     211     198     409  
Insulin requiring diabetes [10]
[units: participants]
 		     
Participants with Insulin dependent Diabetes     93     89     182  
Participants with non-Insulin independent Diabetes     163     166     329  
Nondiabetic Participants     641     648     1289  
Medically treated Diabetes [11]
[units: Participants]
 		     
Diabetic Participants Medically Treated     221     231     452  
Diabetic Participants Treated through Diet only     35     24     59  
Non-Diabetic Participants     641     648     1289  
Metabolic Syndrome [12]
[units: participants]
 		     
Participants with a Metabolic Syndrome     317     339     656  
Participants without a Metabolic Syndrome     580     564     1144  
Poor LVEF [13]
[units: participants]
 		     
LVEF <30% at Baseline     22     12     34  
LVEF >=30% at Baseline     875     891     1766  
Prior MI [14]
[units: participants]
 		     
Myocardial Infarction Before Baseline     300     285     585  
No Myocardial Infarction Before Baseline     597     618     1215  
Prior Stroke [15]
[units: participants]
 		     
Stroke Prior to Baseline     43     35     78  
No Stroke Prior to Baseline     854     868     1722  
Prior TIA [16]
[units: participants]
 		     
Transient Ischemic Attack Before Baseline     45     39     84  
No Transient Ischemic Attack before baseline     852     864     1716  
Total Occlusion (per patient) [17]
[units: participants]
 		     
Participants with at least One Total Occlusion     198     217     415  
Participants with Partial Occlusion(s)     699     686     1385  
Triglyceride levels ≥150 mg/dL [18]
[units: participants]
 		     
Participants with Triglyceride Levels >= 150 mg/dL     304     275     579  
Participants with Triglyceride Levels <150 mg/dL     593     628     1221  
Additive Euroscore [19]
[units: units on a scale]
Mean ± Standard Deviation 		  3.79  ± 2.69     3.75  ± 2.62     3.77  ± 2.66  
Body Mass Index (BMI) [20]
[units: kg/m2]
Mean ± Standard Deviation 		  27.91  ± 4.54     28.11  ± 4.80     28.01  ± 4.67  
Number of lesions per partipant [21]
[units: Number of lesions/Participant]
Mean ± Standard Deviation 		  3.99  ± 1.7     3.94  ± 1.66     3.97  ± 1.68  
Parsonnet Score [22]
[units: units on a scale]
Mean ± Standard Deviation 		  8.43  ± 6.84     8.53  ± 6.95     8.48  ± 6.9  
Total Syntax Score [23]
[units: units on a scale]
Mean ± Standard Deviation 		  29.1  ± 11.37     28.39  ± 11.46     28.7  ± 11.42  
[1] number of particpiants with stable, unstable, or no angina at baseline
[2] Number of participants with at least one bifurcation lesion as determined by the angiographic core laboratory on the baseline angiogram
[3] number of participants with blood pressure equal or higher than 130/85mmHg
[4] number of particpants with diagnosed carotid artery disease at baseline
[5] number of particpants with congestive heart failure at baseline
[6] Number of participants that were smoking at baseline
[7] All participants with diagnosed diabetes at baseline
[8] number of male participants with a high-density lipoprotein (HDL)<40 and female particpants with a HDL<50 determined by the central chemistry laboratory
[9] participants with hyperlipidemia at baseline
[10] Number of participants with diabetes treated with insulin
[11] Number of participants with medically treated diabetes.Excludes participants with diabetes treated with diet only.
[12] number of participants that met the criteria of metabolic syndrome defined by the American Heart Association
[13] number of participants with left ventricular ejection fraction <30% at baseline
[14] Number of participants who had a myocardial infarction before baseline
[15] number of participants who had a stroke before baseline
[16] number of partipants who had a Transient Ischemic Attack before baseline
[17] Number of participants with at least one total occlusion as determined by the angiografic core laboratory on the baseline angiogram
[18] participants with Triglyceride levels ≥150 mg/dL as determined by a central chemistry laboratorium at baseline
[19] 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)
[20] Body Mass Index calculated from participants heigth and weight.
[21] Average number of lesions per participant as determined by the investigator
[22] 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.
[23] 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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2.  Primary:   12-month Composite Safety Endpoint.   [ Time Frame: 12 months after enrollment ]
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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 ]
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6.  Secondary:   Individual Components of MACCE at 6 Months Post-allocation.   [ Time Frame: 6 months post allocation ]
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7.  Secondary:   Individual Components of MACCE at 1 Year Post-allocation.   [ Time Frame: 1 year post allocation ]
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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 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
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  Other Adverse Events
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


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
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Results Point of Contact:  
Name/Title: Nic Van Dyck / Senior Program Manager
Organization: Boston Scientific
phone: + 31 43 356 8328
e-mail: vandyckn@bsci.com


No publications provided by Boston Scientific Corporation

Publications automatically indexed to this study:


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