Trial Outcomes & Findings for SYNTAX Study: TAXUS Drug-Eluting Stent Versus Coronary Artery Bypass Surgery for the Treatment of Narrowed Arteries (NCT NCT00114972)
NCT ID: NCT00114972
Last Updated: 2010-06-23
Results Overview
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).
Recruitment status
UNKNOWN
Study phase
PHASE3
Target enrollment
1800 participants
Primary outcome timeframe
12 months post enrollment
Results posted on
2010-06-23
Participant Flow
Participant milestones
| Measure |
CABG
Coronary Artery By-pass Graft (CABG)
|
PCI With DES
Percutaneous coronary intervention (PCI) using TAXUS Express Drug Eluting Stent (DES)
|
|---|---|---|
|
Overall Study
STARTED
|
897
|
903
|
|
Overall Study
COMPLETED
|
849
|
891
|
|
Overall Study
NOT COMPLETED
|
48
|
12
|
Reasons for withdrawal
| Measure |
CABG
Coronary Artery By-pass Graft (CABG)
|
PCI With DES
Percutaneous coronary intervention (PCI) using TAXUS Express Drug Eluting Stent (DES)
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
40
|
7
|
|
Overall Study
Lost to Follow-up
|
8
|
5
|
Baseline Characteristics
SYNTAX Study: TAXUS Drug-Eluting Stent Versus Coronary Artery Bypass Surgery for the Treatment of Narrowed Arteries
Baseline characteristics by cohort
| Measure |
CABG
n=897 Participants
Coronary Artery By-pass Graft (CABG)
|
PCI With DES
n=903 Participants
Percutaneous coronary intervention (PCI) using TAXUS Express Drug Eluting Stent (DES)
|
Total
n=1800 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0.0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
400 Participants
n=5 Participants
|
397 Participants
n=7 Participants
|
797.0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
497 Participants
n=5 Participants
|
506 Participants
n=7 Participants
|
1003.0 Participants
n=5 Participants
|
|
Age Continuous
|
64.96 years
STANDARD_DEVIATION 9.79 • n=5 Participants
|
65.23 years
STANDARD_DEVIATION 9.66 • n=7 Participants
|
65.09 years
STANDARD_DEVIATION 9.72 • n=5 Participants
|
|
Sex: Female, Male
Female
|
189 Participants
n=5 Participants
|
213 Participants
n=7 Participants
|
402 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
708 Participants
n=5 Participants
|
690 Participants
n=7 Participants
|
1398 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
122 participants
n=5 Participants
|
123 participants
n=7 Participants
|
245.0 participants
n=5 Participants
|
|
Region of Enrollment
Portugal
|
7 participants
n=5 Participants
|
6 participants
n=7 Participants
|
13.0 participants
n=5 Participants
|
|
Region of Enrollment
Finland
|
12 participants
n=5 Participants
|
12 participants
n=7 Participants
|
24.0 participants
n=5 Participants
|
|
Region of Enrollment
Spain
|
26 participants
n=5 Participants
|
27 participants
n=7 Participants
|
53.0 participants
n=5 Participants
|
|
Region of Enrollment
Austria
|
24 participants
n=5 Participants
|
28 participants
n=7 Participants
|
52.0 participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
132 participants
n=5 Participants
|
135 participants
n=7 Participants
|
267.0 participants
n=5 Participants
|
|
Region of Enrollment
Italy
|
96 participants
n=5 Participants
|
101 participants
n=7 Participants
|
197.0 participants
n=5 Participants
|
|
Region of Enrollment
France
|
105 participants
n=5 Participants
|
103 participants
n=7 Participants
|
208.0 participants
n=5 Participants
|
|
Region of Enrollment
Hungary
|
39 participants
n=5 Participants
|
44 participants
n=7 Participants
|
83.0 participants
n=5 Participants
|
|
Region of Enrollment
Czech Republic
|
20 participants
n=5 Participants
|
20 participants
n=7 Participants
|
40.0 participants
n=5 Participants
|
|
Region of Enrollment
Poland
|
33 participants
n=5 Participants
|
33 participants
n=7 Participants
|
66.0 participants
n=5 Participants
|
|
Region of Enrollment
Belgium
|
47 participants
n=5 Participants
|
44 participants
n=7 Participants
|
91.0 participants
n=5 Participants
|
|
Region of Enrollment
Denmark
|
15 participants
n=5 Participants
|
17 participants
n=7 Participants
|
32.0 participants
n=5 Participants
|
|
Region of Enrollment
Norway
|
4 participants
n=5 Participants
|
4 participants
n=7 Participants
|
8.0 participants
n=5 Participants
|
|
Region of Enrollment
Latvia
|
20 participants
n=5 Participants
|
20 participants
n=7 Participants
|
40.0 participants
n=5 Participants
|
|
Region of Enrollment
Netherlands
|
74 participants
n=5 Participants
|
74 participants
n=7 Participants
|
148.0 participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
93 participants
n=5 Participants
|
86 participants
n=7 Participants
|
179.0 participants
n=5 Participants
|
|
Region of Enrollment
Sweden
|
28 participants
n=5 Participants
|
26 participants
n=7 Participants
|
54.0 participants
n=5 Participants
|
|
Angina
Participants with Stable Angina at Baseline
|
513 participants
n=5 Participants
|
514 participants
n=7 Participants
|
1027.0 participants
n=5 Participants
|
|
Angina
Participants with Unstable Angina at Baseline
|
251 participants
n=5 Participants
|
261 participants
n=7 Participants
|
512.0 participants
n=5 Participants
|
|
Angina
Participants with Silent Ischemia at Baseline
|
74 participants
n=5 Participants
|
74 participants
n=7 Participants
|
148.0 participants
n=5 Participants
|
|
Angina
Participants with No Angina at Baseline
|
59 participants
n=5 Participants
|
54 participants
n=7 Participants
|
113.0 participants
n=5 Participants
|
|
Bifurcation lesion (per participant)
One or more Bifurcated Lesion(s)
|
652 participants
n=5 Participants
|
649 participants
n=7 Participants
|
1301.0 participants
n=5 Participants
|
|
Bifurcation lesion (per participant)
No Bifurcated Lesions
|
245 participants
n=5 Participants
|
254 participants
n=7 Participants
|
499.0 participants
n=5 Participants
|
|
Blood pressure ≥130/85 mmHg
Blood Pressure >= 130/85 mmHG
|
574 participants
n=5 Participants
|
622 participants
n=7 Participants
|
1196.0 participants
n=5 Participants
|
|
Blood pressure ≥130/85 mmHg
Blood Pressure <130/85 mmHG
|
323 participants
n=5 Participants
|
281 participants
n=7 Participants
|
604.0 participants
n=5 Participants
|
|
Carotid artery disease
Diagnosed Carotid Artery Disease at Baseline
|
75 participants
n=5 Participants
|
73 participants
n=7 Participants
|
148.0 participants
n=5 Participants
|
|
Carotid artery disease
No Diagnosed Carotid Artery Disease at Baseline
|
822 participants
n=5 Participants
|
830 participants
n=7 Participants
|
1652.0 participants
n=5 Participants
|
|
Congestive heart failure
Congestive Heart Failure at Baseline
|
47 participants
n=5 Participants
|
36 participants
n=7 Participants
|
83.0 participants
n=5 Participants
|
|
Congestive heart failure
No Congestive Heart Failure at Baseline
|
850 participants
n=5 Participants
|
867 participants
n=7 Participants
|
1717.0 participants
n=5 Participants
|
|
Current smoking
Smokers at Baseline
|
196 participants
n=5 Participants
|
167 participants
n=7 Participants
|
363.0 participants
n=5 Participants
|
|
Current smoking
Non-Smokers at Baseline
|
701 participants
n=5 Participants
|
736 participants
n=7 Participants
|
1437.0 participants
n=5 Participants
|
|
Diabetes
Diagnosed Diabetes at Baseline
|
256 participants
n=5 Participants
|
255 participants
n=7 Participants
|
511.0 participants
n=5 Participants
|
|
Diabetes
No Diagnosed Diabetes at Baseline
|
641 participants
n=5 Participants
|
648 participants
n=7 Participants
|
1289.0 participants
n=5 Participants
|
|
HDL cholesterol (<40 Male or <50 Female)
Participant HDL Less Than Limit at Baseline
|
404 participants
n=5 Participants
|
379 participants
n=7 Participants
|
783.0 participants
n=5 Participants
|
|
HDL cholesterol (<40 Male or <50 Female)
Participant HDL Greater Than Limit at Baseline
|
493 participants
n=5 Participants
|
524 participants
n=7 Participants
|
1017.0 participants
n=5 Participants
|
|
Hyperlipidemia
Participants with Hyperlipidemia at Baseline
|
686 participants
n=5 Participants
|
705 participants
n=7 Participants
|
1391.0 participants
n=5 Participants
|
|
Hyperlipidemia
Participants without Hyperlipidemia at Baseline
|
211 participants
n=5 Participants
|
198 participants
n=7 Participants
|
409.0 participants
n=5 Participants
|
|
Insulin requiring diabetes
Participants with Insulin dependent Diabetes
|
93 participants
n=5 Participants
|
89 participants
n=7 Participants
|
182.0 participants
n=5 Participants
|
|
Insulin requiring diabetes
Participants with non-Insulin independent Diabetes
|
163 participants
n=5 Participants
|
166 participants
n=7 Participants
|
329.0 participants
n=5 Participants
|
|
Insulin requiring diabetes
Nondiabetic Participants
|
641 participants
n=5 Participants
|
648 participants
n=7 Participants
|
1289.0 participants
n=5 Participants
|
|
Medically treated Diabetes
Diabetic Participants Medically Treated
|
221 Participants
n=5 Participants
|
231 Participants
n=7 Participants
|
452.0 Participants
n=5 Participants
|
|
Medically treated Diabetes
Diabetic Participants Treated through Diet only
|
35 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
59.0 Participants
n=5 Participants
|
|
Medically treated Diabetes
Non-Diabetic Participants
|
641 Participants
n=5 Participants
|
648 Participants
n=7 Participants
|
1289.0 Participants
n=5 Participants
|
|
Metabolic Syndrome
Participants with a Metabolic Syndrome
|
317 participants
n=5 Participants
|
339 participants
n=7 Participants
|
656.0 participants
n=5 Participants
|
|
Metabolic Syndrome
Participants without a Metabolic Syndrome
|
580 participants
n=5 Participants
|
564 participants
n=7 Participants
|
1144.0 participants
n=5 Participants
|
|
Poor LVEF
LVEF <30% at Baseline
|
22 participants
n=5 Participants
|
12 participants
n=7 Participants
|
34.0 participants
n=5 Participants
|
|
Poor LVEF
LVEF >=30% at Baseline
|
875 participants
n=5 Participants
|
891 participants
n=7 Participants
|
1766.0 participants
n=5 Participants
|
|
Prior MI
Myocardial Infarction Before Baseline
|
300 participants
n=5 Participants
|
285 participants
n=7 Participants
|
585.0 participants
n=5 Participants
|
|
Prior MI
No Myocardial Infarction Before Baseline
|
597 participants
n=5 Participants
|
618 participants
n=7 Participants
|
1215.0 participants
n=5 Participants
|
|
Prior Stroke
Stroke Prior to Baseline
|
43 participants
n=5 Participants
|
35 participants
n=7 Participants
|
78.0 participants
n=5 Participants
|
|
Prior Stroke
No Stroke Prior to Baseline
|
854 participants
n=5 Participants
|
868 participants
n=7 Participants
|
1722.0 participants
n=5 Participants
|
|
Prior TIA
Transient Ischemic Attack Before Baseline
|
45 participants
n=5 Participants
|
39 participants
n=7 Participants
|
84.0 participants
n=5 Participants
|
|
Prior TIA
No Transient Ischemic Attack before baseline
|
852 participants
n=5 Participants
|
864 participants
n=7 Participants
|
1716.0 participants
n=5 Participants
|
|
Total Occlusion (per patient)
Participants with at least One Total Occlusion
|
198 participants
n=5 Participants
|
217 participants
n=7 Participants
|
415.0 participants
n=5 Participants
|
|
Total Occlusion (per patient)
Participants with Partial Occlusion(s)
|
699 participants
n=5 Participants
|
686 participants
n=7 Participants
|
1385.0 participants
n=5 Participants
|
|
Triglyceride levels ≥150 mg/dL
Participants with Triglyceride Levels >= 150 mg/dL
|
304 participants
n=5 Participants
|
275 participants
n=7 Participants
|
579.0 participants
n=5 Participants
|
|
Triglyceride levels ≥150 mg/dL
Participants with Triglyceride Levels <150 mg/dL
|
593 participants
n=5 Participants
|
628 participants
n=7 Participants
|
1221.0 participants
n=5 Participants
|
|
Additive Euroscore
|
3.79 units on a scale
STANDARD_DEVIATION 2.69 • n=5 Participants
|
3.75 units on a scale
STANDARD_DEVIATION 2.62 • n=7 Participants
|
3.77 units on a scale
STANDARD_DEVIATION 2.66 • n=5 Participants
|
|
Body Mass Index (BMI)
|
27.91 kg/m2
STANDARD_DEVIATION 4.54 • n=5 Participants
|
28.11 kg/m2
STANDARD_DEVIATION 4.80 • n=7 Participants
|
28.01 kg/m2
STANDARD_DEVIATION 4.67 • n=5 Participants
|
|
Number of lesions per partipant
|
3.99 Number of lesions/Participant
STANDARD_DEVIATION 1.7 • n=5 Participants
|
3.94 Number of lesions/Participant
STANDARD_DEVIATION 1.66 • n=7 Participants
|
3.97 Number of lesions/Participant
STANDARD_DEVIATION 1.68 • n=5 Participants
|
|
Parsonnet Score
|
8.43 units on a scale
STANDARD_DEVIATION 6.84 • n=5 Participants
|
8.53 units on a scale
STANDARD_DEVIATION 6.95 • n=7 Participants
|
8.48 units on a scale
STANDARD_DEVIATION 6.9 • n=5 Participants
|
|
Total Syntax Score
|
29.1 units on a scale
STANDARD_DEVIATION 11.37 • n=5 Participants
|
28.39 units on a scale
STANDARD_DEVIATION 11.46 • n=7 Participants
|
28.7 units on a scale
STANDARD_DEVIATION 11.42 • n=5 Participants
|
PRIMARY outcome
Timeframe: 12 months post enrollmentPopulation: ITT analysis. Number of participants analyzed equals number of subjects who completed Overall Study, as listed in Participant Flow.
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).
Outcome measures
| Measure |
CABG
n=849 Participants
Coronary Artery By-pass Graft (CABG)
|
PCI With DES
n=891 Participants
Percutaneous coronary intervention (PCI) using TAXUS Express Drug Eluting Stent (DES)
|
|---|---|---|
|
Primary Clinical Endpoint of 12-Month Binary MACCE.
|
105 participants
|
159 participants
|
PRIMARY outcome
Timeframe: 12 months after enrollmentNumber of participants at 12-month composite safety endpoint. Composite safety endpoint combines: all cause death, cerebrovascular event (stroke), and documented myocardial infarction.
Outcome measures
| Measure |
CABG
n=849 Participants
Coronary Artery By-pass Graft (CABG)
|
PCI With DES
n=891 Participants
Percutaneous coronary intervention (PCI) using TAXUS Express Drug Eluting Stent (DES)
|
|---|---|---|
|
12-month Composite Safety Endpoint.
|
65 participants
|
68 participants
|
PRIMARY outcome
Timeframe: 12 Months post enrollmentNumber of participants with repeat revascularization (PCI and/or CABG).
Outcome measures
| Measure |
CABG
n=849 Participants
Coronary Artery By-pass Graft (CABG)
|
PCI With DES
n=891 Participants
Percutaneous coronary intervention (PCI) using TAXUS Express Drug Eluting Stent (DES)
|
|---|---|---|
|
Repeat Revascularization (PCI and/or CABG).
|
50 Participants
|
120 Participants
|
SECONDARY outcome
Timeframe: 1 month after procedure and 6 months, 3 years, and 5 years post allocationNumber of participants with Overall MACCE at 1 month post-procedure and at 6 months, 3 years, and 5 years post-allocation.
Outcome measures
| Measure |
CABG
n=849 Participants
Coronary Artery By-pass Graft (CABG)
|
PCI With DES
n=891 Participants
Percutaneous coronary intervention (PCI) using TAXUS Express Drug Eluting Stent (DES)
|
|---|---|---|
|
Overall MACCE at 1 Month Post-procedure and at 6 Months, 3 Years, and 5 Years Post-allocation.
MACCE 1 month post procedure
|
45 participants
|
54 participants
|
|
Overall MACCE at 1 Month Post-procedure and at 6 Months, 3 Years, and 5 Years Post-allocation.
MACCE 6 months post procedure
|
85 participants
|
111 participants
|
SECONDARY outcome
Timeframe: 1 month after procedurePopulation: ITT analysis
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.
Outcome measures
| Measure |
CABG
n=866 Participants
Coronary Artery By-pass Graft (CABG)
|
PCI With DES
n=895 Participants
Percutaneous coronary intervention (PCI) using TAXUS Express Drug Eluting Stent (DES)
|
|---|---|---|
|
Individual Components of MACCE at 1 Month Post-procedure.
Documented MI
|
21 participants
|
31 participants
|
|
Individual Components of MACCE at 1 Month Post-procedure.
Any repeat revascularization
|
15 participants
|
31 participants
|
|
Individual Components of MACCE at 1 Month Post-procedure.
All cause death
|
10 participants
|
20 participants
|
|
Individual Components of MACCE at 1 Month Post-procedure.
Stroke
|
9 participants
|
2 participants
|
SECONDARY outcome
Timeframe: 6 months post allocationPopulation: ITT analysis
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.
Outcome measures
| Measure |
CABG
n=860 Participants
Coronary Artery By-pass Graft (CABG)
|
PCI With DES
n=893 Participants
Percutaneous coronary intervention (PCI) using TAXUS Express Drug Eluting Stent (DES)
|
|---|---|---|
|
Individual Components of MACCE at 6 Months Post-allocation.
Stroke
|
13 Participants
|
2 Participants
|
|
Individual Components of MACCE at 6 Months Post-allocation.
Documented MI
|
27 Participants
|
40 Participants
|
|
Individual Components of MACCE at 6 Months Post-allocation.
All cause death
|
24 Participants
|
31 Participants
|
|
Individual Components of MACCE at 6 Months Post-allocation.
Any repeat revascularization
|
35 Participants
|
78 Participants
|
SECONDARY outcome
Timeframe: 1 year post allocationPopulation: ITT analysis
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.
Outcome measures
| Measure |
CABG
n=849 Participants
Coronary Artery By-pass Graft (CABG)
|
PCI With DES
n=891 Participants
Percutaneous coronary intervention (PCI) using TAXUS Express Drug Eluting Stent (DES)
|
|---|---|---|
|
Individual Components of MACCE at 1 Year Post-allocation.
Any repeat revascularization
|
50 participants
|
120 participants
|
|
Individual Components of MACCE at 1 Year Post-allocation.
Death any cause
|
30 participants
|
39 participants
|
|
Individual Components of MACCE at 1 Year Post-allocation.
Stroke
|
19 participants
|
5 participants
|
|
Individual Components of MACCE at 1 Year Post-allocation.
Documented MI
|
28 participants
|
43 participants
|
SECONDARY outcome
Timeframe: 1 year post allocationNumber 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).
Outcome measures
| Measure |
CABG
n=849 Participants
Coronary Artery By-pass Graft (CABG)
|
PCI With DES
n=891 Participants
Percutaneous coronary intervention (PCI) using TAXUS Express Drug Eluting Stent (DES)
|
|---|---|---|
|
Freedom From MACCE and Its Components at 1 Year Post-allocation.
Freedom from any MACCE
|
744 participants
|
732 participants
|
|
Freedom From MACCE and Its Components at 1 Year Post-allocation.
Freedom from any cause death
|
819 participants
|
852 participants
|
|
Freedom From MACCE and Its Components at 1 Year Post-allocation.
Freedom from stroke
|
830 participants
|
886 participants
|
|
Freedom From MACCE and Its Components at 1 Year Post-allocation.
Freedom from documented MI
|
821 participants
|
848 participants
|
|
Freedom From MACCE and Its Components at 1 Year Post-allocation.
Freedom from any repeat revascularization
|
799 participants
|
771 participants
|
SECONDARY outcome
Timeframe: 3 years post allocationOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 5 years post allocationOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 1 month after procedure and 6 months, 1, 3 and 5 years post allocationOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 1 year, 3 and 5 years post allocationOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 5 YearsOutcome measures
Outcome data not reported
Adverse Events
CABG
Serious events: 391 serious events
Other events: 509 other events
Deaths: 0 deaths
PCI With DES
Serious events: 357 serious events
Other events: 405 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
CABG
n=897 participants at risk
Coronary Artery By-pass Graft (CABG)
|
PCI With DES
n=903 participants at risk
Percutaneous coronary intervention (PCI) using TAXUS Express Drug Eluting Stent (DES)
|
|---|---|---|
|
Investigations
Abnormal blood test values
|
1.6%
14/897 • Number of events 15 • 1 year
|
2.0%
18/903 • Number of events 19 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
1.9%
17/897 • Number of events 17 • 1 year
|
0.22%
2/903 • Number of events 2 • 1 year
|
|
Blood and lymphatic system disorders
Anaemia
|
3.0%
27/897 • Number of events 31 • 1 year
|
2.2%
20/903 • Number of events 20 • 1 year
|
|
Immune system disorders
Anaphylactic shock , reaction and drug hypersensitivity
|
0.11%
1/897 • Number of events 1 • 1 year
|
0.22%
2/903 • Number of events 2 • 1 year
|
|
Cardiac disorders
Angina Pectoris
|
3.3%
30/897 • Number of events 49 • 1 year
|
8.2%
74/903 • Number of events 95 • 1 year
|
|
Cardiac disorders
Angina Unstable
|
3.3%
30/897 • Number of events 38 • 1 year
|
7.3%
66/903 • Number of events 85 • 1 year
|
|
Cardiac disorders
Arrhythmia, other rare cardiac disorders
|
5.7%
51/897 • Number of events 58 • 1 year
|
9.1%
82/903 • Number of events 99 • 1 year
|
|
Cardiac disorders
Atrial Fibrillation
|
5.0%
45/897 • Number of events 47 • 1 year
|
1.1%
10/903 • Number of events 14 • 1 year
|
|
Cardiac disorders
Atrial Flutter
|
1.1%
10/897 • Number of events 11 • 1 year
|
0.22%
2/903 • Number of events 2 • 1 year
|
|
Endocrine disorders
Basedow's Disease
|
0.00%
0/897 • 1 year
|
0.11%
1/903 • Number of events 1 • 1 year
|
|
Cardiac disorders
Bradycardia
|
0.78%
7/897 • Number of events 8 • 1 year
|
1.4%
13/903 • Number of events 13 • 1 year
|
|
Cardiac disorders
Cardiac Arrest
|
1.2%
11/897 • Number of events 11 • 1 year
|
1.7%
15/903 • Number of events 15 • 1 year
|
|
Cardiac disorders
Cardiac Failure
|
1.3%
12/897 • Number of events 14 • 1 year
|
0.78%
7/903 • Number of events 7 • 1 year
|
|
Cardiac disorders
Cardiac Failure Congestive
|
1.3%
12/897 • Number of events 14 • 1 year
|
0.78%
7/903 • Number of events 8 • 1 year
|
|
Investigations
Cardiac enzymes increased
|
0.33%
3/897 • Number of events 3 • 1 year
|
1.1%
10/903 • Number of events 10 • 1 year
|
|
Cardiac disorders
Cardiac tamponade
|
1.1%
10/897 • Number of events 14 • 1 year
|
0.33%
3/903 • Number of events 4 • 1 year
|
|
Cardiac disorders
Cardiogenic Shock
|
0.33%
3/897 • Number of events 3 • 1 year
|
1.6%
14/903 • Number of events 15 • 1 year
|
|
Nervous system disorders
Carotid artery stenosis
|
1.0%
9/897 • Number of events 9 • 1 year
|
0.22%
2/903 • Number of events 3 • 1 year
|
|
Eye disorders
Cataract, lens disorder, renal detachment
|
0.33%
3/897 • Number of events 4 • 1 year
|
0.33%
3/903 • Number of events 4 • 1 year
|
|
General disorders
Catheter site haematoma
|
0.11%
1/897 • Number of events 1 • 1 year
|
1.2%
11/903 • Number of events 11 • 1 year
|
|
Cardiac disorders
Coronary Artery Thrombosis
|
0.22%
2/897 • Number of events 2 • 1 year
|
3.1%
28/903 • Number of events 41 • 1 year
|
|
Gastrointestinal disorders
Gastrointestinal Haemorrhage
|
1.3%
12/897 • Number of events 13 • 1 year
|
1.3%
12/903 • Number of events 12 • 1 year
|
|
Hepatobiliary disorders
Hepatobiliary disorders
|
0.78%
7/897 • Number of events 7 • 1 year
|
0.33%
3/903 • Number of events 3 • 1 year
|
|
Infections and infestations
Infection and abcess
|
4.9%
44/897 • Number of events 45 • 1 year
|
3.0%
27/903 • Number of events 27 • 1 year
|
|
Injury, poisoning and procedural complications
Injury and procedural complications
|
3.7%
33/897 • Number of events 35 • 1 year
|
1.7%
15/903 • Number of events 16 • 1 year
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders
|
1.3%
12/897 • Number of events 12 • 1 year
|
0.66%
6/903 • Number of events 6 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue diorders
|
1.3%
12/897 • Number of events 12 • 1 year
|
1.3%
12/903 • Number of events 12 • 1 year
|
|
Cardiac disorders
Myocardial Ischaemia
|
0.22%
2/897 • Number of events 2 • 1 year
|
2.0%
18/903 • Number of events 19 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms
|
1.2%
11/897 • Number of events 11 • 1 year
|
1.6%
14/903 • Number of events 14 • 1 year
|
|
Nervous system disorders
Nervous system disorder
|
2.6%
23/897 • Number of events 25 • 1 year
|
1.4%
13/903 • Number of events 13 • 1 year
|
|
General disorders
Non-cardiac chest pain
|
0.67%
6/897 • Number of events 6 • 1 year
|
1.6%
14/903 • Number of events 19 • 1 year
|
|
Gastrointestinal disorders
Other gastrointestinal disorders
|
2.3%
21/897 • Number of events 24 • 1 year
|
1.2%
11/903 • Number of events 12 • 1 year
|
|
General disorders
Other general disorders and administration site conditions
|
3.0%
27/897 • Number of events 28 • 1 year
|
2.9%
26/903 • Number of events 26 • 1 year
|
|
Cardiac disorders
Pericardial Effusion
|
1.1%
10/897 • Number of events 11 • 1 year
|
0.22%
2/903 • Number of events 2 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
2.9%
26/897 • Number of events 33 • 1 year
|
0.00%
0/903 • 1 year
|
|
Infections and infestations
Pneumonia
|
1.1%
10/897 • Number of events 10 • 1 year
|
0.66%
6/903 • Number of events 6 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
1.4%
13/897 • Number of events 13 • 1 year
|
0.00%
0/903 • 1 year
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
1.0%
9/897 • Number of events 9 • 1 year
|
0.11%
1/903 • Number of events 1 • 1 year
|
|
Reproductive system and breast disorders
Prostatic disorders
|
0.67%
6/897 • Number of events 7 • 1 year
|
0.11%
1/903 • Number of events 1 • 1 year
|
|
Psychiatric disorders
Psychiatric disorders
|
1.3%
12/897 • Number of events 12 • 1 year
|
0.33%
3/903 • Number of events 3 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.67%
6/897 • Number of events 6 • 1 year
|
1.1%
10/903 • Number of events 10 • 1 year
|
|
Renal and urinary disorders
Renal and urinary disorders
|
1.4%
13/897 • Number of events 15 • 1 year
|
1.4%
13/903 • Number of events 13 • 1 year
|
|
Renal and urinary disorders
Renal failure acute
|
2.5%
22/897 • Number of events 23 • 1 year
|
1.00%
9/903 • Number of events 9 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders
|
3.5%
31/897 • Number of events 31 • 1 year
|
2.2%
20/903 • Number of events 20 • 1 year
|
|
Infections and infestations
Sepsis
|
1.0%
9/897 • Number of events 11 • 1 year
|
0.66%
6/903 • Number of events 7 • 1 year
|
|
Surgical and medical procedures
Surgical and medical procedures
|
0.22%
2/897 • Number of events 2 • 1 year
|
0.00%
0/903 • 1 year
|
|
Vascular disorders
Vascular disorders
|
5.0%
45/897 • Number of events 48 • 1 year
|
5.3%
48/903 • Number of events 48 • 1 year
|
|
Injury, poisoning and procedural complications
Vascular graft occlusion
|
3.1%
28/897 • Number of events 29 • 1 year
|
0.11%
1/903 • Number of events 1 • 1 year
|
|
Ear and labyrinth disorders
Vertigo Positional
|
0.00%
0/897 • 1 year
|
0.11%
1/903 • Number of events 1 • 1 year
|
|
Infections and infestations
Wound infection
|
3.3%
30/897 • Number of events 33 • 1 year
|
0.11%
1/903 • Number of events 1 • 1 year
|
|
Blood and lymphatic system disorders
coagulopathy, iron deficiency anaemia, leukocytosis, thrombocyopenia
|
0.45%
4/897 • Number of events 4 • 1 year
|
0.33%
3/903 • Number of events 3 • 1 year
|
|
Skin and subcutaneous tissue disorders
skin and subcutaneous tissue disorders
|
0.45%
4/897 • Number of events 4 • 1 year
|
0.33%
3/903 • Number of events 3 • 1 year
|
Other adverse events
| Measure |
CABG
n=897 participants at risk
Coronary Artery By-pass Graft (CABG)
|
PCI With DES
n=903 participants at risk
Percutaneous coronary intervention (PCI) using TAXUS Express Drug Eluting Stent (DES)
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
11.6%
104/897 • Number of events 109 • 1 year
|
2.5%
23/903 • Number of events 24 • 1 year
|
|
Cardiac disorders
Angina pectoris
|
2.9%
26/897 • Number of events 28 • 1 year
|
6.8%
61/903 • Number of events 70 • 1 year
|
|
Cardiac disorders
Atrial fibrillation
|
13.7%
123/897 • Number of events 129 • 1 year
|
2.8%
25/903 • Number of events 28 • 1 year
|
|
Injury, poisoning and procedural complications
Incision site complication
|
5.2%
47/897 • Number of events 52 • 1 year
|
0.33%
3/903 • Number of events 3 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
6.0%
54/897 • Number of events 55 • 1 year
|
0.22%
2/903 • Number of events 2 • 1 year
|
|
Infections and infestations
Wound infection
|
6.2%
56/897 • Number of events 58 • 1 year
|
0.22%
2/903 • Number of events 2 • 1 year
|
|
General disorders
All other Adverse Events
|
56.7%
509/897 • Number of events 1099 • 1 year
|
44.9%
405/903 • Number of events 854 • 1 year
|
Additional Information
Nic Van Dyck / Senior Program Manager
Boston Scientific
Phone: + 31 43 356 8328
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60