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


  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  
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
  Show All Outcome Measures

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 ]

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
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Time Frame 1 year
Additional Description 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)

Serious Adverse Events
    CABG     PCI With DES  
Total, serious adverse events      
# participants affected / at risk     391/897 (43.59%)     357/903 (39.53%)  
Blood and lymphatic system disorders      
Anaemia * 1    
# participants affected / at risk     27/897 (3.01%)     20/903 (2.21%)  
# events     31     20  
coagulopathy, iron deficiency anaemia, leukocytosis, thrombocyopenia * 1 [3]    
# participants affected / at risk     4/897 (0.45%)     3/903 (0.33%)  
# events     4     3  
Cardiac disorders      
Angina Pectoris * 1    
# participants affected / at risk     30/897 (3.34%)     74/903 (8.19%)  
# events     49     95  
Angina Unstable * 1    
# participants affected / at risk     30/897 (3.34%)     66/903 (7.31%)  
# events     38     85  
Arrhythmia, other rare cardiac disorders * 1 [4]    
# participants affected / at risk     51/897 (5.69%)     82/903 (9.08%)  
# events     58     99  
Atrial Fibrillation * 1    
# participants affected / at risk     45/897 (5.02%)     10/903 (1.11%)  
# events     47     14  
Atrial Flutter * 1    
# participants affected / at risk     10/897 (1.11%)     2/903 (0.22%)  
# events     11     2  
Bradycardia * 1    
# participants affected / at risk     7/897 (0.78%)     13/903 (1.44%)  
# events     8     13  
Cardiac Arrest * 1    
# participants affected / at risk     11/897 (1.23%)     15/903 (1.66%)  
# events     11     15  
Cardiac Failure * 1    
# participants affected / at risk     12/897 (1.34%)     7/903 (0.78%)  
# events     14     7  
Cardiac Failure Congestive * 1    
# participants affected / at risk     12/897 (1.34%)     7/903 (0.78%)  
# events     14     8  
Cardiac tamponade * 1    
# participants affected / at risk     10/897 (1.11%)     3/903 (0.33%)  
# events     14     4  
Cardiogenic Shock * 1    
# participants affected / at risk     3/897 (0.33%)     14/903 (1.55%)  
# events     3     15  
Coronary Artery Thrombosis * 1    
# participants affected / at risk     2/897 (0.22%)     28/903 (3.10%)  
# events     2     41  
Myocardial Ischaemia * 1    
# participants affected / at risk     2/897 (0.22%)     18/903 (1.99%)  
# events     2     19  
Pericardial Effusion * 1    
# participants affected / at risk     10/897 (1.11%)     2/903 (0.22%)  
# events     11     2  
Ear and labyrinth disorders      
Vertigo Positional * 1    
# participants affected / at risk     0/897 (0.00%)     1/903 (0.11%)  
# events     0     1  
Endocrine disorders      
Basedow's Disease * 1    
# participants affected / at risk     0/897 (0.00%)     1/903 (0.11%)  
# events     0     1  
Eye disorders      
Cataract, lens disorder, renal detachment * 1    
# participants affected / at risk     3/897 (0.33%)     3/903 (0.33%)  
# events     4     4  
Gastrointestinal disorders      
Gastrointestinal Haemorrhage * 1    
# participants affected / at risk     12/897 (1.34%)     12/903 (1.33%)  
# events     13     12  
Other gastrointestinal disorders * 1 [5]    
# participants affected / at risk     21/897 (2.34%)     11/903 (1.22%)  
# events     24     12  
General disorders      
Catheter site haematoma * 1    
# participants affected / at risk     1/897 (0.11%)     11/903 (1.22%)  
# events     1     11  
Non-cardiac chest pain * 1    
# participants affected / at risk     6/897 (0.67%)     14/903 (1.55%)  
# events     6     19  
Other general disorders and administration site conditions * 1 [6]    
# participants affected / at risk     27/897 (3.01%)     26/903 (2.88%)  
# events     28     26  
Hepatobiliary disorders      
Hepatobiliary disorders * 1 [7]    
# participants affected / at risk     7/897 (0.78%)     3/903 (0.33%)  
# events     7     3  
Immune system disorders      
Anaphylactic shock , reaction and drug hypersensitivity * 1 [8]    
# participants affected / at risk     1/897 (0.11%)     2/903 (0.22%)  
# events     1     2  
Infections and infestations      
Infection and abcess * 1 [9]    
# participants affected / at risk     44/897 (4.91%)     27/903 (2.99%)  
# events     45     27  
Pneumonia * 1    
# participants affected / at risk     10/897 (1.11%)     6/903 (0.66%)  
# events     10     6  
Sepsis * 1    
# participants affected / at risk     9/897 (1.00%)     6/903 (0.66%)  
# events     11     7  
Wound infection * 1    
# participants affected / at risk     30/897 (3.34%)     1/903 (0.11%)  
# events     33     1  
Injury, poisoning and procedural complications      
Injury and procedural complications * 1 [10]    
# participants affected / at risk     33/897 (3.68%)     15/903 (1.66%)  
# events     35     16  
Post procedural haemorrhage * 1    
# participants affected / at risk     9/897 (1.00%)     1/903 (0.11%)  
# events     9     1  
Vascular graft occlusion * 1    
# participants affected / at risk     28/897 (3.12%)     1/903 (0.11%)  
# events     29     1  
Investigations      
Abnormal blood test values * 1 [11]    
# participants affected / at risk     14/897 (1.56%)     18/903 (1.99%)  
# events     15     19  
Cardiac enzymes increased * 1    
# participants affected / at risk     3/897 (0.33%)     10/903 (1.11%)  
# events     3     10  
Metabolism and nutrition disorders      
Metabolism and nutrition disorders * 1 [12]    
# participants affected / at risk     12/897 (1.34%)     6/903 (0.66%)  
# events     12     6  
Musculoskeletal and connective tissue disorders      
Musculoskeletal and connective tissue diorders * 1 [13]    
# participants affected / at risk     12/897 (1.34%)     12/903 (1.33%)  
# events     12     12  
Neoplasms benign, malignant and unspecified (incl cysts and polyps)      
Neoplasms * 1 [14]    
# participants affected / at risk     11/897 (1.23%)     14/903 (1.55%)  
# events     11     14  
Nervous system disorders      
Carotid artery stenosis * 1    
# participants affected / at risk     9/897 (1.00%)     2/903 (0.22%)  
# events     9     3  
Nervous system disorder * 1 [15]    
# participants affected / at risk     23/897 (2.56%)     13/903 (1.44%)  
# events     25     13  
Psychiatric disorders      
Psychiatric disorders * 1 [16]    
# participants affected / at risk     12/897 (1.34%)     3/903 (0.33%)  
# events     12     3  
Renal and urinary disorders      
Renal and urinary disorders * 1 [17]    
# participants affected / at risk     13/897 (1.45%)     13/903 (1.44%)  
# events     15     13  
Renal failure acute * 1    
# participants affected / at risk     22/897 (2.45%)     9/903 (1.00%)  
# events     23     9  
Reproductive system and breast disorders      
Prostatic disorders * 1 [18]    
# participants affected / at risk     6/897 (0.67%)     1/903 (0.11%)  
# events     7     1  
Respiratory, thoracic and mediastinal disorders      
Acute respiratory failure * 1    
# participants affected / at risk     17/897 (1.90%)     2/903 (0.22%)  
# events     17     2  
Pleural effusion * 1    
# participants affected / at risk     26/897 (2.90%)     0/903 (0.00%)  
# events     33     0  
Pneumothorax * 1    
# participants affected / at risk     13/897 (1.45%)     0/903 (0.00%)  
# events     13     0  
Pulmonary oedema * 1    
# participants affected / at risk     6/897 (0.67%)     10/903 (1.11%)  
# events     6     10  
Respiratory, thoracic and mediastinal disorders * 1 [19]    
# participants affected / at risk     31/897 (3.46%)     20/903 (2.21%)  
# events     31     20  
Skin and subcutaneous tissue disorders      
skin and subcutaneous tissue disorders * 1 [20]    
# participants affected / at risk     4/897 (0.45%)     3/903 (0.33%)  
# events     4     3  
Surgical and medical procedures      
Surgical and medical procedures * 1 [21]    
# participants affected / at risk     2/897 (0.22%)     0/903 (0.00%)  
# events     2     0  
Vascular disorders      
Vascular disorders * 1 [22]    
# participants affected / at risk     45/897 (5.02%)     48/903 (5.32%)  
# events     48     48  
* Events were collected by non-systematic assessment
1 Term from vocabulary, MedDRA (8.0)
[3] Total of other events and subjects affected with these events in this organ system. Event terms are coagulopathy, iron deficiency anaemia, leukocytosis and thrombocyopenia. Occurrence of each individual event term is less than 1%.
[4] Rare cardiac disorders like ventricular arrhytmias, atrioventricular blocks, cardiomyopathy, valve disease, coronary artery dissection and occlusion. Occurrence of each individual event term is less than 1%.
[5] Sum of all other gastrointestinal disorders like ulcers, pain, hernia, obstructions, vomiting, nausea, etc. Occurrence of each individual event term is less than 1%.
[6] Other general disorders mainly related to catheter site events like pain, haemorrhage and pyrexia, multi-organ failure, wound healing problems. Occurrence of each individual event term is less than 1%.
[7] Total of hepatobiliary disorders like bile duct stone, cholecystitis, hepatic failure and hepatic function abnormal.Occurrence of each individual event term is less than 1%.
[8] Total of events related to immune system disorder like anaphylactic reaction or shock and drug hypersensitivity. Occurrence of each individual event term is less than 1%.
[9] Total of any other infection or abcess. Occurrence of each individual event term is less than 1%.
[10] Total of all other procedural complications and injuries. Occurrence of each individual event term is less than 1%.
[11] Total of all abnormal blood tests (increased or decreased) and abnormal diagnostic procedures. Occurrence of each individual event term is less than 1%.
[12] Total of all metabolism and nutrition disorders like hyper- and hypoglycaemie, hypokalaemia, hyponatraemia, dehydration, etc. Occurrence of each individual event term is less than 1%.
[13] Total of musculoskeletal and connective tissue disorders. Occurrence of each individual event term is less than 1%.
[14] Total of neoplasms, benign, malignant and unspecified. Occurrence of each individual event term is less than 1%.
[15] Total of all other nervous system disorders. Occurrence of each individual event term is less than 1%.
[16] Total of all psychiatric disorders. Occurrence of each individual event term is less than 1%.
[17] Total of all other renal and urinary disorders. Occurrence of each individual event term is less than 1%.
[18] Total of all reproductive system and breast disorders. All events in this system were related to prostatic disorders. Occurrence of each individual event term is less than 1%.
[19] Total of all other respiratory, thoracic and mediastinal disorders. Occurrence of each individual event term is less than 1%.
[20] Total of skin and subcutaneous tissue disorders. Occurrence of each individual event term is less than 1%.
[21] Total of surgical and medical procedures. Occurrence of each individual event term is less than 1%.
[22] Total of vascular disorders. Occurrence of each individual event term is less than 1%.




  Other Adverse Events


  Limitations and Caveats
  Hide 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.


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