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

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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
Enrollment 1800
Recruitment Details  
Pre-assignment Details  
Arm/Group Title CABG PCI With DES
Hide Arm/Group Description Coronary Artery By-pass Graft (CABG) Percutaneous coronary intervention (PCI) using TAXUS Express Drug Eluting Stent (DES)
Period Title: Overall Study
Started 897 903
Completed 849 891
Not Completed 48 12
Reason Not Completed
Withdrawal by Subject             40             7
Lost to Follow-up             8             5
Arm/Group Title CABG PCI With DES Total
Hide Arm/Group Description Coronary Artery By-pass Graft (CABG) Percutaneous coronary intervention (PCI) using TAXUS Express Drug Eluting Stent (DES) Total of all reporting groups
Overall Number of Baseline Participants 897 903 1800
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 897 participants 903 participants 1800 participants
<=18 years
0
   0.0%
0
   0.0%
0.0
Between 18 and 65 years
400
  44.6%
397
  44.0%
797.0
>=65 years
497
  55.4%
506
  56.0%
1003.0
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 897 participants 903 participants 1800 participants
64.96  (9.79) 65.23  (9.66) 65.09  (9.72)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 897 participants 903 participants 1800 participants
Female
189
  21.1%
213
  23.6%
402
  22.3%
Male
708
  78.9%
690
  76.4%
1398
  77.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 897 participants 903 participants 1800 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] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 897 participants 903 participants 1800 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]
Measure Description: number of particpiants with stable, unstable, or no angina at baseline
Bifurcation lesion (per participant)   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 897 participants 903 participants 1800 participants
One or more Bifurcated Lesion(s) 652 649 1301
No Bifurcated Lesions 245 254 499
[1]
Measure Description: 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] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 897 participants 903 participants 1800 participants
Blood Pressure >= 130/85 mmHG 574 622 1196
Blood Pressure <130/85 mmHG 323 281 604
[1]
Measure Description: number of participants with blood pressure equal or higher than 130/85mmHg
Carotid artery disease   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 897 participants 903 participants 1800 participants
Diagnosed Carotid Artery Disease at Baseline 75 73 148
No Diagnosed Carotid Artery Disease at Baseline 822 830 1652
[1]
Measure Description: number of particpants with diagnosed carotid artery disease at baseline
Congestive heart failure   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 897 participants 903 participants 1800 participants
Congestive Heart Failure at Baseline 47 36 83
No Congestive Heart Failure at Baseline 850 867 1717
[1]
Measure Description: number of particpants with congestive heart failure at baseline
Current smoking   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 897 participants 903 participants 1800 participants
Smokers at Baseline 196 167 363
Non-Smokers at Baseline 701 736 1437
[1]
Measure Description: Number of participants that were smoking at baseline
Diabetes   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 897 participants 903 participants 1800 participants
Diagnosed Diabetes at Baseline 256 255 511
No Diagnosed Diabetes at Baseline 641 648 1289
[1]
Measure Description: All participants with diagnosed diabetes at baseline
HDL cholesterol (<40 Male or <50 Female)   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 897 participants 903 participants 1800 participants
Participant HDL Less Than Limit at Baseline 404 379 783
Participant HDL Greater Than Limit at Baseline 493 524 1017
[1]
Measure Description: 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] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 897 participants 903 participants 1800 participants
Participants with Hyperlipidemia at Baseline 686 705 1391
Participants without Hyperlipidemia at Baseline 211 198 409
[1]
Measure Description: participants with hyperlipidemia at baseline
Insulin requiring diabetes   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 897 participants 903 participants 1800 participants
Participants with Insulin dependent Diabetes 93 89 182
Participants with non-Insulin independent Diabetes 163 166 329
Nondiabetic Participants 641 648 1289
[1]
Measure Description: Number of participants with diabetes treated with insulin
Medically treated Diabetes   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 897 participants 903 participants 1800 participants
Diabetic Participants Medically Treated 221 231 452
Diabetic Participants Treated through Diet only 35 24 59
Non-Diabetic Participants 641 648 1289
[1]
Measure Description: Number of participants with medically treated diabetes.Excludes participants with diabetes treated with diet only.
Metabolic Syndrome   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 897 participants 903 participants 1800 participants
Participants with a Metabolic Syndrome 317 339 656
Participants without a Metabolic Syndrome 580 564 1144
[1]
Measure Description: number of participants that met the criteria of metabolic syndrome defined by the American Heart Association
Poor LVEF   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 897 participants 903 participants 1800 participants
LVEF <30% at Baseline 22 12 34
LVEF >=30% at Baseline 875 891 1766
[1]
Measure Description: number of participants with left ventricular ejection fraction <30% at baseline
Prior MI   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 897 participants 903 participants 1800 participants
Myocardial Infarction Before Baseline 300 285 585
No Myocardial Infarction Before Baseline 597 618 1215
[1]
Measure Description: Number of participants who had a myocardial infarction before baseline
Prior Stroke   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 897 participants 903 participants 1800 participants
Stroke Prior to Baseline 43 35 78
No Stroke Prior to Baseline 854 868 1722
[1]
Measure Description: number of participants who had a stroke before baseline
Prior TIA   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 897 participants 903 participants 1800 participants
Transient Ischemic Attack Before Baseline 45 39 84
No Transient Ischemic Attack before baseline 852 864 1716
[1]
Measure Description: number of partipants who had a Transient Ischemic Attack before baseline
Total Occlusion (per patient)   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 897 participants 903 participants 1800 participants
Participants with at least One Total Occlusion 198 217 415
Participants with Partial Occlusion(s) 699 686 1385
[1]
Measure Description: 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] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 897 participants 903 participants 1800 participants
Participants with Triglyceride Levels >= 150 mg/dL 304 275 579
Participants with Triglyceride Levels <150 mg/dL 593 628 1221
[1]
Measure Description: participants with Triglyceride levels ≥150 mg/dL as determined by a central chemistry laboratorium at baseline
Additive Euroscore   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 897 participants 903 participants 1800 participants
3.79  (2.69) 3.75  (2.62) 3.77  (2.66)
[1]
Measure Description: 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] 
Mean (Standard Deviation)
Unit of measure:  Kg/m2
Number Analyzed 897 participants 903 participants 1800 participants
27.91  (4.54) 28.11  (4.80) 28.01  (4.67)
[1]
Measure Description: Body Mass Index calculated from participants heigth and weight.
Number of lesions per partipant   [1] 
Mean (Standard Deviation)
Unit of measure:  Number of lesions/Participant
Number Analyzed 897 participants 903 participants 1800 participants
3.99  (1.7) 3.94  (1.66) 3.97  (1.68)
[1]
Measure Description: Average number of lesions per participant as determined by the investigator
Parsonnet Score   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 897 participants 903 participants 1800 participants
8.43  (6.84) 8.53  (6.95) 8.48  (6.9)
[1]
Measure Description: 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] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 897 participants 903 participants 1800 participants
29.1  (11.37) 28.39  (11.46) 28.7  (11.42)
[1]
Measure Description: 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)
1.Primary Outcome
Title Primary Clinical Endpoint of 12-Month Binary MACCE.
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT analysis. Number of participants analyzed equals number of subjects who completed Overall Study, as listed in Participant Flow.
Arm/Group Title CABG PCI With DES
Hide Arm/Group Description:
Coronary Artery By-pass Graft (CABG)
Percutaneous coronary intervention (PCI) using TAXUS Express Drug Eluting Stent (DES)
Overall Number of Participants Analyzed 849 891
Measure Type: Number
Unit of Measure: participants
105 159
2.Primary Outcome
Title 12-month Composite Safety Endpoint.
Hide Description Number of participants at 12-month composite safety endpoint. Composite safety endpoint combines: all cause death, cerebrovascular event (stroke), and documented myocardial infarction.
Time Frame 12 months after enrollment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title CABG PCI With DES
Hide Arm/Group Description:
Coronary Artery By-pass Graft (CABG)
Percutaneous coronary intervention (PCI) using TAXUS Express Drug Eluting Stent (DES)
Overall Number of Participants Analyzed 849 891
Measure Type: Number
Unit of Measure: participants
65 68
3.Primary Outcome
Title Repeat Revascularization (PCI and/or CABG).
Hide Description Number of participants with repeat revascularization (PCI and/or CABG).
Time Frame 12 Months post enrollment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title CABG PCI With DES
Hide Arm/Group Description:
Coronary Artery By-pass Graft (CABG)
Percutaneous coronary intervention (PCI) using TAXUS Express Drug Eluting Stent (DES)
Overall Number of Participants Analyzed 849 891
Measure Type: Number
Unit of Measure: Participants
50 120
4.Secondary Outcome
Title Overall MACCE at 1 Month Post-procedure and at 6 Months, 3 Years, and 5 Years Post-allocation.
Hide Description Number of participants with 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 DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title CABG PCI With DES
Hide Arm/Group Description:
Coronary Artery By-pass Graft (CABG)
Percutaneous coronary intervention (PCI) using TAXUS Express Drug Eluting Stent (DES)
Overall Number of Participants Analyzed 849 891
Measure Type: Number
Unit of Measure: participants
MACCE 1 month post procedure 45 54
MACCE 6 months post procedure 85 111
5.Secondary Outcome
Title Individual Components of MACCE at 1 Month Post-procedure.
Hide Description Number of participants with individual components of MACCE at 1 month post-procedure. The individual components of MACCE are: all cause death, stroke, documented myocardial infarction, repeat revascularization.
Time Frame 1 month after procedure
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT analysis
Arm/Group Title CABG PCI With DES
Hide Arm/Group Description:
Coronary Artery By-pass Graft (CABG)
Percutaneous coronary intervention (PCI) using TAXUS Express Drug Eluting Stent (DES)
Overall Number of Participants Analyzed 866 895
Measure Type: Number
Unit of Measure: participants
All cause death 10 20
Stroke 9 2
Documented MI 21 31
Any repeat revascularization 15 31
6.Secondary Outcome
Title Individual Components of MACCE at 6 Months Post-allocation.
Hide Description Number of participants with individual components of MACCE at 6 months post-allocation. The individual components of MACCE are: all cause death, stroke, documented myocardial infarction, repeat revascularization.
Time Frame 6 months post allocation
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT analysis
Arm/Group Title CABG PCI With DES
Hide Arm/Group Description:
Coronary Artery By-pass Graft (CABG)
Percutaneous coronary intervention (PCI) using TAXUS Express Drug Eluting Stent (DES)
Overall Number of Participants Analyzed 860 893
Measure Type: Number
Unit of Measure: Participants
All cause death 24 31
Stroke 13 2
Documented MI 27 40
Any repeat revascularization 35 78
7.Secondary Outcome
Title Individual Components of MACCE at 1 Year Post-allocation.
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT analysis
Arm/Group Title CABG PCI With DES
Hide Arm/Group Description:
Coronary Artery By-pass Graft (CABG)
Percutaneous coronary intervention (PCI) using TAXUS Express Drug Eluting Stent (DES)
Overall Number of Participants Analyzed 849 891
Measure Type: Number
Unit of Measure: participants
Death any cause 30 39
Stroke 19 5
Documented MI 28 43
Any repeat revascularization 50 120
8.Secondary Outcome
Title Freedom From MACCE and Its Components at 1 Year Post-allocation.
Hide Description Number of participants with freedom from MACCE and its components at 1 year post-allocation. Freedom from MACCE is defined as no MACCE nor any of the individual components of MACCE (all cause death, stroke, documented myocardial infarction, repeat revascularization).
Time Frame 1 year post allocation
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title CABG PCI With DES
Hide Arm/Group Description:
Coronary Artery By-pass Graft (CABG)
Percutaneous coronary intervention (PCI) using TAXUS Express Drug Eluting Stent (DES)
Overall Number of Participants Analyzed 849 891
Measure Type: Number
Unit of Measure: participants
Freedom from any MACCE 744 732
Freedom from any cause death 819 852
Freedom from stroke 830 886
Freedom from documented MI 821 848
Freedom from any repeat revascularization 799 771
9.Secondary Outcome
Title Freedom From MACCE and Its Components at 3 Years Post-allocation
Hide Description [Not Specified]
Time Frame 3 years post allocation
Outcome Measure Data Not Reported
10.Secondary Outcome
Title Freedom From MACCE and Its Components at 5 Years Post-allocation
Hide Description [Not Specified]
Time Frame 5 years post allocation
Outcome Measure Data Not Reported
11.Secondary Outcome
Title Quality of Life at 1 Month Post-procedure and at 6 Months, 1, 3 and 5 Years Post-allocation
Hide Description [Not Specified]
Time Frame 1 month after procedure and 6 months, 1, 3 and 5 years post allocation
Outcome Measure Data Not Reported
12.Secondary Outcome
Title Cost and Cost-effectiveness at 1, 3 and 5 Years Post-allocation
Hide Description [Not Specified]
Time Frame 1 year, 3 and 5 years post allocation
Outcome Measure Data Not Reported
13.Secondary Outcome
Title 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)
Hide Description [Not Specified]
Time Frame 5 Years
Outcome Measure Data Not Reported
Time Frame 1 year
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title CABG PCI With DES
Hide Arm/Group Description Coronary Artery By-pass Graft (CABG) Percutaneous coronary intervention (PCI) using TAXUS Express Drug Eluting Stent (DES)
All-Cause Mortality
CABG PCI With DES
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
CABG PCI With DES
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   391/897 (43.59%)      357/903 (39.53%)    
Blood and lymphatic system disorders     
Anaemia * 1  27/897 (3.01%)  31 20/903 (2.21%)  20
coagulopathy, iron deficiency anaemia, leukocytosis, thrombocyopenia * 1 [1]  4/897 (0.45%)  4 3/903 (0.33%)  3
Cardiac disorders     
Angina Pectoris * 1  30/897 (3.34%)  49 74/903 (8.19%)  95
Angina Unstable * 1  30/897 (3.34%)  38 66/903 (7.31%)  85
Arrhythmia, other rare cardiac disorders * 1 [2]  51/897 (5.69%)  58 82/903 (9.08%)  99
Atrial Fibrillation * 1  45/897 (5.02%)  47 10/903 (1.11%)  14
Atrial Flutter * 1  10/897 (1.11%)  11 2/903 (0.22%)  2
Bradycardia * 1  7/897 (0.78%)  8 13/903 (1.44%)  13
Cardiac Arrest * 1  11/897 (1.23%)  11 15/903 (1.66%)  15
Cardiac Failure * 1  12/897 (1.34%)  14 7/903 (0.78%)  7
Cardiac Failure Congestive * 1  12/897 (1.34%)  14 7/903 (0.78%)  8
Cardiac tamponade * 1  10/897 (1.11%)  14 3/903 (0.33%)  4
Cardiogenic Shock * 1  3/897 (0.33%)  3 14/903 (1.55%)  15
Coronary Artery Thrombosis * 1  2/897 (0.22%)  2 28/903 (3.10%)  41
Myocardial Ischaemia * 1  2/897 (0.22%)  2 18/903 (1.99%)  19
Pericardial Effusion * 1  10/897 (1.11%)  11 2/903 (0.22%)  2
Ear and labyrinth disorders     
Vertigo Positional * 1  0/897 (0.00%)  0 1/903 (0.11%)  1
Endocrine disorders     
Basedow's Disease * 1  0/897 (0.00%)  0 1/903 (0.11%)  1
Eye disorders     
Cataract, lens disorder, renal detachment * 1  3/897 (0.33%)  4 3/903 (0.33%)  4
Gastrointestinal disorders     
Gastrointestinal Haemorrhage * 1  12/897 (1.34%)  13 12/903 (1.33%)  12
Other gastrointestinal disorders * 1 [3]  21/897 (2.34%)  24 11/903 (1.22%)  12
General disorders     
Catheter site haematoma * 1  1/897 (0.11%)  1 11/903 (1.22%)  11
Non-cardiac chest pain * 1  6/897 (0.67%)  6 14/903 (1.55%)  19
Other general disorders and administration site conditions * 1 [4]  27/897 (3.01%)  28 26/903 (2.88%)  26
Hepatobiliary disorders     
Hepatobiliary disorders * 1 [5]  7/897 (0.78%)  7 3/903 (0.33%)  3
Immune system disorders     
Anaphylactic shock , reaction and drug hypersensitivity * 1 [6]  1/897 (0.11%)  1 2/903 (0.22%)  2
Infections and infestations     
Infection and abcess * 1 [7]  44/897 (4.91%)  45 27/903 (2.99%)  27
Pneumonia * 1  10/897 (1.11%)  10 6/903 (0.66%)  6
Sepsis * 1  9/897 (1.00%)  11 6/903 (0.66%)  7
Wound infection * 1  30/897 (3.34%)  33 1/903 (0.11%)  1
Injury, poisoning and procedural complications     
Injury and procedural complications * 1 [8]  33/897 (3.68%)  35 15/903 (1.66%)  16
Post procedural haemorrhage * 1  9/897 (1.00%)  9 1/903 (0.11%)  1
Vascular graft occlusion * 1  28/897 (3.12%)  29 1/903 (0.11%)  1
Investigations     
Abnormal blood test values * 1 [9]  14/897 (1.56%)  15 18/903 (1.99%)  19
Cardiac enzymes increased * 1  3/897 (0.33%)  3 10/903 (1.11%)  10
Metabolism and nutrition disorders     
Metabolism and nutrition disorders * 1 [10]  12/897 (1.34%)  12 6/903 (0.66%)  6
Musculoskeletal and connective tissue disorders     
Musculoskeletal and connective tissue diorders * 1 [11]  12/897 (1.34%)  12 12/903 (1.33%)  12
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Neoplasms * 1 [12]  11/897 (1.23%)  11 14/903 (1.55%)  14
Nervous system disorders     
Carotid artery stenosis * 1  9/897 (1.00%)  9 2/903 (0.22%)  3
Nervous system disorder * 1 [13]  23/897 (2.56%)  25 13/903 (1.44%)  13
Psychiatric disorders     
Psychiatric disorders * 1 [14]  12/897 (1.34%)  12 3/903 (0.33%)  3
Renal and urinary disorders     
Renal and urinary disorders * 1 [15]  13/897 (1.45%)  15 13/903 (1.44%)  13
Renal failure acute * 1  22/897 (2.45%)  23 9/903 (1.00%)  9
Reproductive system and breast disorders     
Prostatic disorders * 1 [16]  6/897 (0.67%)  7 1/903 (0.11%)  1
Respiratory, thoracic and mediastinal disorders     
Acute respiratory failure * 1  17/897 (1.90%)  17 2/903 (0.22%)  2
Pleural effusion * 1  26/897 (2.90%)  33 0/903 (0.00%)  0
Pneumothorax * 1  13/897 (1.45%)  13 0/903 (0.00%)  0
Pulmonary oedema * 1  6/897 (0.67%)  6 10/903 (1.11%)  10
Respiratory, thoracic and mediastinal disorders * 1 [17]  31/897 (3.46%)  31 20/903 (2.21%)  20
Skin and subcutaneous tissue disorders     
skin and subcutaneous tissue disorders * 1 [18]  4/897 (0.45%)  4 3/903 (0.33%)  3
Surgical and medical procedures     
Surgical and medical procedures * 1 [19]  2/897 (0.22%)  2 0/903 (0.00%)  0
Vascular disorders     
Vascular disorders * 1 [20]  45/897 (5.02%)  48 48/903 (5.32%)  48
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (8.0)
[1]
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%.
[2]
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%.
[3]
Sum of all other gastrointestinal disorders like ulcers, pain, hernia, obstructions, vomiting, nausea, etc. Occurrence of each individual event term is less than 1%.
[4]
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%.
[5]
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%.
[6]
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%.
[7]
Total of any other infection or abcess. Occurrence of each individual event term is less than 1%.
[8]
Total of all other procedural complications and injuries. Occurrence of each individual event term is less than 1%.
[9]
Total of all abnormal blood tests (increased or decreased) and abnormal diagnostic procedures. Occurrence of each individual event term is less than 1%.
[10]
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%.
[11]
Total of musculoskeletal and connective tissue disorders. Occurrence of each individual event term is less than 1%.
[12]
Total of neoplasms, benign, malignant and unspecified. Occurrence of each individual event term is less than 1%.
[13]
Total of all other nervous system disorders. Occurrence of each individual event term is less than 1%.
[14]
Total of all psychiatric disorders. Occurrence of each individual event term is less than 1%.
[15]
Total of all other renal and urinary disorders. Occurrence of each individual event term is less than 1%.
[16]
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%.
[17]
Total of all other respiratory, thoracic and mediastinal disorders. Occurrence of each individual event term is less than 1%.
[18]
Total of skin and subcutaneous tissue disorders. Occurrence of each individual event term is less than 1%.
[19]
Total of surgical and medical procedures. Occurrence of each individual event term is less than 1%.
[20]
Total of vascular disorders. Occurrence of each individual event term is less than 1%.
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
CABG PCI With DES
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   509/897 (56.74%)      405/903 (44.85%)    
Blood and lymphatic system disorders     
Anaemia * 1  104/897 (11.59%)  109 23/903 (2.55%)  24
Cardiac disorders     
Angina pectoris * 1  26/897 (2.90%)  28 61/903 (6.76%)  70
Atrial fibrillation * 1  123/897 (13.71%)  129 25/903 (2.77%)  28
General disorders     
All other Adverse Events * 1 [1]  509/897 (56.74%)  1099 405/903 (44.85%)  854
Infections and infestations     
Wound infection * 1  56/897 (6.24%)  58 2/903 (0.22%)  2
Injury, poisoning and procedural complications     
Incision site complication * 1  47/897 (5.24%)  52 3/903 (0.33%)  3
Respiratory, thoracic and mediastinal disorders     
Pleural effusion * 1  54/897 (6.02%)  55 2/903 (0.22%)  2
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (8.0)
[1]
Total of all other adverse events with an occurrence below the 5% treshold.
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.
Results Point of Contact
Name/Title: Nic Van Dyck / Senior Program Manager
Organization: Boston Scientific
Phone: + 31 43 356 8328
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Nic Van Dyck, Boston Scientific
ClinicalTrials.gov Identifier: NCT00114972     History of Changes
Other Study ID Numbers: S2024
90169394
First Submitted: June 20, 2005
First Posted: June 21, 2005
Results First Submitted: March 27, 2009
Results First Posted: June 23, 2010
Last Update Posted: June 23, 2010