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TAXUS Libertē Post Approval Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00997503
Recruitment Status : Completed
First Posted : October 19, 2009
Results First Posted : April 13, 2015
Last Update Posted : August 7, 2015
Sponsor:
Collaborators:
Eli Lilly and Company
Daiichi Sankyo, Inc.
Information provided by (Responsible Party):
Boston Scientific Corporation

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Prospective
Condition Coronary Artery Disease
Interventions Device: TAXUS Liberté Paclitaxel-Eluting Coronary Stent
Drug: prasugrel
Drug: placebo
Drug: aspirin
Enrollment 4199
Recruitment Details  
Pre-assignment Details  
Arm/Group Title TAXUS Libertē: Overall Enrolled Population
Hide Arm/Group Description Overall enrolled population of patients: received at least one TAXUS Liberté Paclitaxel-Eluting Coronary Stent System in routine clinical practice, in conjunction with the use of prasugrel and aspirin.
Period Title: Overall Study
Started 4199
12 Months 4059 [1]
Completed 3926
Not Completed 273
Reason Not Completed
Death             53
Withdrawal by Subject             76
Lost to Follow-up             33
Adverse Event             3
Physician Decision             10
Missed 12-month follow-up             85
Other reason             13
[1]
4059 subjects evaluable at 12-months (cardiac death/MI within 365 days or completed follow-up)
Arm/Group Title TAXUS Liberté Post-Approval Study Enrolled Population
Hide Arm/Group Description Overall enrolled population of patients: received at least one TAXUS Liberté Paclitaxel-Eluting Coronary Stent System in routine clinical practice, in conjunction with the use of prasugrel and aspirin.
Overall Number of Baseline Participants 4199
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 4199 participants
59.8  (9.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4199 participants
Female
1161
  27.6%
Male
3038
  72.4%
Race/Ethnicity, Customized   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 4199 participants
Hispanic or Latino 181
Caucasian 3623
Asian 23
Black, or African Heritage 323
Native Hawaiian or Other Pacific Islander 8
American Indian or Alaska Native 16
Other 43
[1]
Measure Description: Some participants may be allocated to greater than one category.
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 4199 participants
4199
Weight  
Mean (Standard Deviation)
Unit of measure:  Kilograms
Number Analyzed 4199 participants
92.9  (20.7)
Smoking Status  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 4199 participants
Current 1272
Previous 1451
Never 1387
Unknown 89
History of Hyperlipidemia Requiring Medication  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 4199 participants
2950
History of Hypertension Requiring Medication  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 4199 participants
3130
Diabetic (Medically Treated)  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 4199 participants
1289
Family History of Coronary Artery Disease (CAD)  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 4199 participants
2466
History of Atrial Fibrillation  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 4199 participants
143
History of Coronary Artery Bypass Graft (CABG)  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 4199 participants
559
History of Percutaneous Coronary Intervention (PCI)  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 4199 participants
1411
History of Congestive Heart Failure (CHF)  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 4199 participants
254
Current Stable Angina   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 4199 participants
1320
[1]
Measure Description: Canadian Cardiology Society Classification (CCSC)
Current Unstable Angina  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 4199 participants
1385
Current Silent Ischemia  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 4199 participants
310
Current Myocardial Infarction (MI)  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 4199 participants
1040
Experiencing Cardiogenic Shock   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 4199 participants
17
[1]
Measure Description: A clinical state of hypoperfusion characterized by systolic pressure <80 mm Hg and/or central filling pressure >20 mm Hg, or cardiac index <1.8 liters/minute/m2 where there is evidence of insufficient end organ profusion. Shock is also considered present if intravenous inotropes and/or intra-aortic balloon pump are needed to maintain a systolic blood pressure >80 mm Hg and a cardiac index >1.8 liters/minute/ m2.
History of Multivessel Disease   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 4199 participants
1464
[1]
Measure Description: The presence of a greater than 50% diameter stenosis in 2 or 3 major epicardial coronary vessels or bypassed branches.
History of Left Main Disease  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 4199 participants
155
History of Transient Ischemic Attack (TIA)  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 4199 participants
4
History of Stroke  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 4199 participants
4
Current Renal Dysfunction  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 4199 participants
185
History of Peripheral Vascular Disease  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 4199 participants
284
History of Major Bleeding  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 4199 participants
32
De Novo Lesion   [1] 
Measure Type: Number
Unit of measure:  Lesions
Number Analyzed 4199 participants
5421
[1]
Measure Description: A coronary lesion not previously treated.
Culprit Lesion for ST Elevation Myocardial Infarction (STEMI)  
Measure Type: Number
Unit of measure:  Lesions
Number Analyzed 4199 participants
386
Restenosis  
Measure Type: Number
Unit of measure:  Lesions
Number Analyzed 4199 participants
Restenosis - Drug Eluting Stent (DES) 168
Restenosis - Bare Metal Stent (BMS) 82
Restenotic Lesion (No Stent) 31
Chronic Total Occlusion   [1] 
Measure Type: Number
Unit of measure:  Lesions
Number Analyzed 4199 participants
70
[1]
Measure Description: Lesion that has been totally occluded for three or more months and with a documented TIMI flow of 0.
Ostial Lesion   [1] 
Measure Type: Number
Unit of measure:  Lesions
Number Analyzed 4199 participants
216
[1]
Measure Description: Lesions involving the origin of the coronary artery within the first 3 mm.
Post Brachytherapy  
Measure Type: Number
Unit of measure:  Lesions
Number Analyzed 4199 participants
5
Bifurcated Lesion   [1] 
Measure Type: Number
Unit of measure:  Lesions
Number Analyzed 4199 participants
336
[1]
Measure Description: Lesion where a branch vessel of medium or large size originates.
Reference Vessel Diameter (RVD)  
Mean (Standard Deviation)
Unit of measure:  Millimeters
Number Analyzed 4199 participants
2.99  (0.5)
Lesion Length   [1] 
Mean (Standard Deviation)
Unit of measure:  Millimeters
Number Analyzed 4199 participants
16  (9.5)
[1]
Measure Description: Measured as distance from the proximal to the distal shoulder in the view that demonstrates the stenosis in its most elongated projection; lesion length is recorded as discrete (<10 mm), tubular (10-20 mm), and diffuse (>20 mm).
Pre-Procedure Thrombolysis In Myocardial Infarction (TIMI) Flow   [1] 
Measure Type: Number
Unit of measure:  Lesions
Number Analyzed 4199 participants
0 501
1 197
2 679
3 4283
[1]
Measure Description:

TIMI 0 No perfusion.

TIMI 1 Penetration with minimal perfusion. Contrast fails to opacify the entire bed distal to the stenosis of the duration of the cine run.

TIMI 2 Partial perfusion. Contrast opacifies the entire coronary bed distal to the stenosis. However, the rate of entry and/or clearance is slower in the coronary bed distal to the obstruction than in comparable areas not perfused by the dilated vessel.

TIMI 3 Complete perfusion. Filling and clearance of contrast equally rapid in the coronary bed distal to stenosis as in other coronary beds.

Lesion Classification: American College of Cardiology (ACC)/ American Heart Association (AHA)   [1] 
Measure Type: Number
Unit of measure:  Lesions
Number Analyzed 4199 participants
Type A 1132
Type B1 2298
Type B2 1162
Type C 1068
[1]
Measure Description: Please note the reference section for further definition of the lesion classification.
Lesion Calcification   [1] 
Measure Type: Number
Unit of measure:  Lesions
Number Analyzed 4199 participants
None 3630
Mild 1398
Moderate 482
Severe 150
[1]
Measure Description: Readily apparent densities seen within the artery wall and site of lesion either as an X-ray absorbing mass or as an echogenic and shadow generating mass in IVUS imaging; these can be classified as little/none, moderate, or severe.
Pre-Procedure Target Lesion Percent Diameter Stenosis (%DS)  
Mean (Standard Deviation)
Unit of measure:  Percemt
Number Analyzed 4199 participants
85.3  (11.7)
Vessel Tortuosity  
Measure Type: Number
Unit of measure:  Lesions
Number Analyzed 4199 participants
None 3912
Mild 1261
Moderate 431
Severe 56
Lesion Location (Vessel)  
Measure Type: Number
Unit of measure:  Lesions
Number Analyzed 4199 participants
Right Coronary Artery (RCA) 1943
Left Anterior Descending (LAD) Coronary Artery 2198
Left Circumflex (LCX) Coronary Artery 1306
Left Main (LM) Coronary Artery 46
Arterial or Vein Graft 167
Thrombus Present (Pre-Procedure)  
Measure Type: Number
Unit of measure:  Lesions
Number Analyzed 4199 participants
Yes 478
Possibly 273
No 4840
Unknown 69
Acute Coronary Syndrome (ACS) Present   [1] 
Measure Type: Number
Unit of measure:  Procedures
Number Analyzed 4199 participants
1194
[1]
Measure Description:
  • Subjects may have more than 1 procedure (enrollment and staged)
  • ACS is defined as ischemic symptoms occurring at rest and lasting 10 minutes or more and occurring within 72 hours before index procedure and either ST-segment deviation of 1 mm or more or elevated levels of a cardiac biomarker of necrosis (CK-MB or troponin T or I greater than the upper limit of normal. If CK-MB or troponin is not available, total CK >2 times upper limit of normal). Subjects with STEMI can be enrolled at any time, and will be classified as ACS and therefore complex, within 14 days after onset of symptoms.
Pre-dilatation Performed  
Measure Type: Number
Unit of measure:  Procedures
Number Analyzed 4199 participants
3044
Number of Lesions Treated Per Patient  
Mean (Standard Deviation)
Unit of measure:  Lesions
Number Analyzed 4199 participants
1.3  (0.7)
Number of Vessels Treated Per Patient  
Mean (Standard Deviation)
Unit of measure:  Vessels
Number Analyzed 4199 participants
1.1  (0.4)
Study Stents Implanted Per Patient  
Mean (Standard Deviation)
Unit of measure:  Stents
Number Analyzed 4199 participants
1.5  (0.8)
Post-Procedure Thrombolysis In Myocardial Infarction (TIMI) Flow   [1] 
Measure Type: Number
Unit of measure:  Lesions
Number Analyzed 4199 participants
0 0
1 1
2 42
3 5617
[1]
Measure Description:

TIMI 0 No perfusion.

TIMI 1 Penetration with minimal perfusion. Contrast fails to opacify the entire bed distal to the stenosis of the duration of the cine run.

TIMI 2 Partial perfusion. Contrast opacifies the entire coronary bed distal to the stenosis. However, the rate of entry and/or clearance is slower in the coronary bed distal to the obstruction than in comparable areas not perfused by the dilated vessel.

TIMI 3 Complete perfusion. Filling and clearance of contrast equally rapid in the coronary bed distal to stenosis as in other coronary beds.

Post-Procedure Target Lesion Percent Diameter Stenosis (%DS)  
Mean (Standard Deviation)
Unit of measure:  Percentage of diameter stenosis
Number Analyzed 4199 participants
1.3  (4.2)
Thrombus Present (Post-Procedure)  
Measure Type: Number
Unit of measure:  Lesions
Number Analyzed 4199 participants
Yes 27
Possibly 45
No 5588
1.Primary Outcome
Title Cardiac Death or Myocardial Infarction
Hide Description Cardiac death or myocardial infarction in the TAXUS Liberte Post-Approval Study enrolled population. For pooled data from the TAXUS Liberté and TAXUS Express patient populations, please see the citations.
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
There were 140 patients that were not eligible for the 12-month analyses, as they did not meet the following criteria: either a minimum number of days of follow-up of 335 days or an endpoint event up to 365 days post-stent implant procedure.
Arm/Group Title TAXUS Libertē Post-Approval Study Enrolled Population
Hide Arm/Group Description:
There were a total of 4,199 patients in the TAXUS Libertē Post-Approval Study that received at least one TAXUS Liberte stent.
Overall Number of Participants Analyzed 4059
Measure Type: Number
Unit of Measure: percentage of participants
2.1
2.Secondary Outcome
Title Incremental Rate of Stent Thrombosis (Protocol Definition)
Hide Description

Stent Thrombosis (protocol definition):

The occurrence of any of the following:

  1. Clinical presentation of acute coronary syndrome with angiographic evidence of stent thrombosis:

    Angiographic documentation of acute complete occlusion (TIMI flow 0 or 1) of a previously successfully treated artery (TIMI flow 2 to 3 immediately after stent placement and diameter stenosis less than or equal to 30%) and/or Angiographic documentation of a flow limiting thrombus within or adjacent to a previously successfully treated lesion

  2. Acute MI in the distribution of the treated vessel.
  3. Death within the first 30 days post index procedure (without other obvious cause) is considered a surrogate for stent thrombosis when angiography is not available.
Time Frame 1-2 years
Hide Outcome Measure Data
Hide Analysis Population Description
To be analyzed in this secondary analysis, a subject needed to have an endpoint event between 1-2 years or sufficient follow-up through 2-years. There were 448 subjects that did not meet the criteria for this analysis.
Arm/Group Title TAXUS Libertē: Overall Enrolled Population
Hide Arm/Group Description:
Overall enrolled population of patients: received at least one TAXUS Liberté Paclitaxel-Eluting Coronary Stent System in routine clinical practice, in conjunction with the use of prasugrel and aspirin.
Overall Number of Participants Analyzed 3751
Measure Type: Number
Unit of Measure: percentage of participants
1.3
3.Secondary Outcome
Title Target Vessel Failure (TVF) for the Medically-Treated Diabetic Population
Hide Description Target vessel failure (TVF) for TAXUS Libertē Post-Approval Study medically-treated diabetic population. For pooled data from the TAXUS Liberté population, please see the citations
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
To be included, subject was a medically treated diabetic at the time of enrollment. Also, subjects met the following criteria: either a minimum number of days of follow-up of 335 days or an endpoint event up to 365 days post-stent implant procedure. There were 2945 subjects that did not meet the criteria for this analysis.
Arm/Group Title Medically Treated Diabetic Population
Hide Arm/Group Description:
Patients enrolled in the TAXUS Libertē Post-Approval Study with medically treated diabetes.
Overall Number of Participants Analyzed 1254
Measure Type: Number
Unit of Measure: percentage of participants
6.1
4.Secondary Outcome
Title Rate of Major Adverse Cardiac and Cerebrovascular Events (MACCE)
Hide Description
  • MACCE defined as the composite of cardiac death, myocardial infarction, target vessel revascularization and stroke.
  • Binary rate
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
There were 67 patients that were not eligible for the 6-month analyses, as they did not meet the following criteria: either a minimum number of days of follow-up of 335 days or an endpoint event up to 365 days post-stent implant procedure.
Arm/Group Title TAXUS Liberté: Overall Enrolled Population
Hide Arm/Group Description:
Overall enrolled population of patients: received at least one TAXUS Liberté Paclitaxel-Eluting Coronary Stent System in routine clinical practice, in conjunction with the use of prasugrel and aspirin.
Overall Number of Participants Analyzed 4132
Measure Type: Number
Unit of Measure: percentage of participants
4.7
5.Secondary Outcome
Title Rate of Major Adverse Cardiac and Cerebrovascular Events (MACCE)
Hide Description
  • MACCE defined as the composite of cardiac death, myocardial infarction, target vessel revascularization and stroke.
  • Binary rate
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
There were 140 patients that were not eligible for the 12-month analyses, as they did not meet the following criteria: either a minimum number of days of follow-up of 335 days or an endpoint event up to 365 days post-stent implant procedure.
Arm/Group Title TAXUS Liberté: Overall Enrolled Population
Hide Arm/Group Description:
Overall enrolled population of patients: received at least one TAXUS Liberté Paclitaxel-Eluting Coronary Stent System in routine clinical practice, in conjunction with the use of prasugrel and aspirin.
Overall Number of Participants Analyzed 4059
Measure Type: Number
Unit of Measure: percentage of participants
7.8
6.Secondary Outcome
Title Rate of Major Adverse Cardiac & Cerebrovascular Events (MACCE): Study Stent Related
Hide Description MACCE defined as the composite of cardiac death, myocardial infarction, target vessel revascularization and stroke.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
There were 67 patients that were not eligible for the 6-month analyses, as they did not meet the following criteria: either a minimum number of days of follow-up of 335 days or an endpoint event up to 365 days post-stent implant procedure.
Arm/Group Title TAXUS Liberté: Overall Enrolled Population
Hide Arm/Group Description:
Overall enrolled population of patients: received at least one TAXUS Liberté Paclitaxel-Eluting Coronary Stent System in routine clinical practice, in conjunction with the use of prasugrel and aspirin.
Overall Number of Participants Analyzed 4132
Measure Type: Number
Unit of Measure: percentage of participants
3.1
7.Secondary Outcome
Title Rate of Major Adverse Cardiac and Cerebrovascular Events (MACCE): Study Stent Related
Hide Description
  • MACCE defined as the composite of cardiac death, myocardial infarction, target vessel revascularization and stroke.
  • Binary rate
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
There were 140 patients that were not eligible for the 12-month analyses, as they did not meet the following criteria: either a minimum number of days of follow-up of 335 days or an endpoint event up to 365 days post-stent implant procedure.
Arm/Group Title TAXUS Liberté: Overall Enrolled Population
Hide Arm/Group Description:
Overall enrolled population of patients: received at least one TAXUS Liberté Paclitaxel-Eluting Coronary Stent System in routine clinical practice, in conjunction with the use of prasugrel and aspirin.
Overall Number of Participants Analyzed 4059
Measure Type: Number
Unit of Measure: percentage of participants
4.9
8.Secondary Outcome
Title Rate of Major Adverse Cardiac Events (MACE)
Hide Description
  • MACE defined as the composite of cardiac death, myocardial infarction and target vessel revascularization.
  • Binary rate
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
There were 67 patients that were not eligible for the 6-month analyses, as they did not meet the following criteria: either a minimum number of days of follow-up of 335 days or an endpoint event up to 365 days post-stent implant procedure.
Arm/Group Title TAXUS Liberté: Overall Enrolled Population
Hide Arm/Group Description:
Overall enrolled population of patients: received at least one TAXUS Liberté Paclitaxel-Eluting Coronary Stent System in routine clinical practice, in conjunction with the use of prasugrel and aspirin.
Overall Number of Participants Analyzed 4132
Measure Type: Number
Unit of Measure: percentage of participants
4.3
9.Secondary Outcome
Title Rate of Major Adverse Cardiac Events (MACE)
Hide Description
  • MACE defined as the composite of cardiac death, myocardial infarction and target vessel revascularization.
  • Binary rate
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
There were 140 patients that were not eligible for the 12-month analyses, as they did not meet the following criteria: either a minimum number of days of follow-up of 335 days or an endpoint event up to 365 days post-stent implant procedure.
Arm/Group Title TAXUS Liberté: Overall Enrolled Population
Hide Arm/Group Description:
Overall enrolled population of patients: received at least one TAXUS Liberté Paclitaxel-Eluting Coronary Stent System in routine clinical practice, in conjunction with the use of prasugrel and aspirin.
Overall Number of Participants Analyzed 4059
Measure Type: Number
Unit of Measure: percentage of participants
7.3
10.Secondary Outcome
Title Rate of Major Adverse Cardiac Events (MACE): Study Stent Related
Hide Description
  • MACE defined as the composite of cardiac death, myocardial infarction and target vessel revascularization.
  • Binary rate
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
There were 67 patients that were not eligible for the 6-month analyses, as they did not meet the following criteria: either a minimum number of days of follow-up of 335 days or an endpoint event up to 365 days post-stent implant procedure.
Arm/Group Title TAXUS Liberté: Overall Enrolled Population
Hide Arm/Group Description:
Overall enrolled population of patients: received at least one TAXUS Liberté Paclitaxel-Eluting Coronary Stent System in routine clinical practice, in conjunction with the use of prasugrel and aspirin.
Overall Number of Participants Analyzed 4132
Measure Type: Number
Unit of Measure: percentage of participants
3.1
11.Secondary Outcome
Title Rate of Major Adverse Cardiac Events (MACE): Study Stent Related
Hide Description
  • MACE defined as the composite of cardiac death, myocardial infarction and target vessel revascularization.
  • Binary rate
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
There were 140 patients that were not eligible for the 12-month analyses, as they did not meet the following criteria: either a minimum number of days of follow-up of 335 days or an endpoint event up to 365 days post-stent implant procedure.
Arm/Group Title TAXUS Liberté: Overall Enrolled Population
Hide Arm/Group Description:
Overall enrolled population of patients: received at least one TAXUS Liberté Paclitaxel-Eluting Coronary Stent System in routine clinical practice, in conjunction with the use of prasugrel and aspirin.
Overall Number of Participants Analyzed 4059
Measure Type: Number
Unit of Measure: percentage of participants
4.9
12.Secondary Outcome
Title Rate of Target Vessel Failure (TVF)
Hide Description
  • Target vessel failure is defined as any revascularization of the target vessel, MI (Q- and non-Q wave) related to the target vessel, or death related to the target vessel.
  • Binary Rate
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
There were 67 patients that were not eligible for the 6-month analyses, as they did not meet the following criteria: either a minimum number of days of follow-up of 335 days or an endpoint event up to 365 days post-stent implant procedure.
Arm/Group Title TAXUS Liberté: Overall Enrolled Population
Hide Arm/Group Description:
Overall enrolled population of patients: received at least one TAXUS Liberté Paclitaxel-Eluting Coronary Stent System in routine clinical practice, in conjunction with the use of prasugrel and aspirin.
Overall Number of Participants Analyzed 4132
Measure Type: Number
Unit of Measure: percentage of participants
3.9
13.Secondary Outcome
Title Rate of Target Vessel Failure (TVF)
Hide Description
  • Target vessel failure is defined as any revascularization of the target vessel, MI (Q- and non-Q wave) related to the target vessel, or death related to the target vessel.
  • Binary rate
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
There were 140 patients that were not eligible for the 12-month analyses, as they did not meet the following criteria: either a minimum number of days of follow-up of 335 days or an endpoint event up to 365 days post-stent implant procedure.
Arm/Group Title TAXUS Liberté: Overall Enrolled Population
Hide Arm/Group Description:
Overall enrolled population of patients: received at least one TAXUS Liberté Paclitaxel-Eluting Coronary Stent System in routine clinical practice, in conjunction with the use of prasugrel and aspirin.
Overall Number of Participants Analyzed 4059
Measure Type: Number
Unit of Measure: percentage of participants
6.4
14.Secondary Outcome
Title Rate of Cardiac Death or Myocardial Infarction (MI)
Hide Description - Binary Rate
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
There were 67 patients that were not eligible for the 6-month analyses, as they did not meet the following criteria: either a minimum number of days of follow-up of 335 days or an endpoint event up to 365 days post-stent implant procedure.
Arm/Group Title TAXUS Liberté: Overall Enrolled Population
Hide Arm/Group Description:
Overall enrolled population of patients: received at least one TAXUS Liberté Paclitaxel-Eluting Coronary Stent System in routine clinical practice, in conjunction with the use of prasugrel and aspirin.
Overall Number of Participants Analyzed 4132
Measure Type: Number
Unit of Measure: percentage of participants
1.4
15.Secondary Outcome
Title Rate of Cardiac Death or Myocardial Infarction (MI)
Hide Description - Binary Rate
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
There were 140 patients that were not eligible for the 12-month analyses, as they did not meet the following criteria: either a minimum number of days of follow-up of 335 days or an endpoint event up to 365 days post-stent implant procedure.
Arm/Group Title TAXUS Liberté: Overall Enrolled Population
Hide Arm/Group Description:
Overall enrolled population of patients: received at least one TAXUS Liberté Paclitaxel-Eluting Coronary Stent System in routine clinical practice, in conjunction with the use of prasugrel and aspirin.
Overall Number of Participants Analyzed 4059
Measure Type: Number
Unit of Measure: percentage of participants
2.1
16.Secondary Outcome
Title Rate of All Cause Death
Hide Description -Binary rate
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
There were 67 patients that were not eligible for the 6-month analyses, as they did not meet the following criteria: either a minimum number of days of follow-up of 335 days or an endpoint event up to 365 days post-stent implant procedure.
Arm/Group Title TAXUS Liberté: Overall Enrolled Population
Hide Arm/Group Description:
Overall enrolled population of patients: received at least one TAXUS Liberté Paclitaxel-Eluting Coronary Stent System in routine clinical practice, in conjunction with the use of prasugrel and aspirin.
Overall Number of Participants Analyzed 4132
Measure Type: Number
Unit of Measure: percentage of participants
0.7
17.Secondary Outcome
Title Rate of All Cause Death
Hide Description -Binary rate
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
There were 140 patients that were not eligible for the 12-month analyses, as they did not meet the following criteria: either a minimum number of days of follow-up of 335 days or an endpoint event up to 365 days post-stent implant procedure.
Arm/Group Title TAXUS Liberté: Overall Enrolled Population
Hide Arm/Group Description:
Overall enrolled population of patients: received at least one TAXUS Liberté Paclitaxel-Eluting Coronary Stent System in routine clinical practice, in conjunction with the use of prasugrel and aspirin.
Overall Number of Participants Analyzed 4059
Measure Type: Number
Unit of Measure: percentage of participants
1.4
18.Secondary Outcome
Title Rate of Cardiac Death
Hide Description -Binary rate
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
There were 67 patients that were not eligible for the 6-month analyses, as they did not meet the following criteria: either a minimum number of days of follow-up of 335 days or an endpoint event up to 365 days post-stent implant procedure.
Arm/Group Title TAXUS Liberté: Overall Enrolled Population
Hide Arm/Group Description:
Overall enrolled population of patients: received at least one TAXUS Liberté Paclitaxel-Eluting Coronary Stent System in routine clinical practice, in conjunction with the use of prasugrel and aspirin.
Overall Number of Participants Analyzed 4132
Measure Type: Number
Unit of Measure: percentage of participants
0.4
19.Secondary Outcome
Title Rate of Cardiac Death
Hide Description -Binary rate
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
There were 140 patients that were not eligible for the 12-month analyses, as they did not meet the following criteria: either a minimum number of days of follow-up of 335 days or an endpoint event up to 365 days post-stent implant procedure.
Arm/Group Title TAXUS Liberté: Overall Enrolled Population
Hide Arm/Group Description:
Overall enrolled population of patients: received at least one TAXUS Liberté Paclitaxel-Eluting Coronary Stent System in routine clinical practice, in conjunction with the use of prasugrel and aspirin.
Overall Number of Participants Analyzed 4059
Measure Type: Number
Unit of Measure: percentage of participants
0.9
20.Secondary Outcome
Title Rate of Cardiac Death: Study Stent Related
Hide Description -Binary rate
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
There were 67 patients that were not eligible for the 6-month analyses, as they did not meet the following criteria: either a minimum number of days of follow-up of 335 days or an endpoint event up to 365 days post-stent implant procedure.
Arm/Group Title TAXUS Liberté: Overall Enrolled Population
Hide Arm/Group Description:
Overall enrolled population of patients: received at least one TAXUS Liberté Paclitaxel-Eluting Coronary Stent System in routine clinical practice, in conjunction with the use of prasugrel and aspirin.
Overall Number of Participants Analyzed 4132
Measure Type: Number
Unit of Measure: percentage of participants
0.1
21.Secondary Outcome
Title Rate of Cardiac Death: Study Stent Related
Hide Description -Binary rate
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
There were 140 patients that were not eligible for the 12-month analyses, as they did not meet the following criteria: either a minimum number of days of follow-up of 335 days or an endpoint event up to 365 days post-stent implant procedure.
Arm/Group Title TAXUS Liberté: Overall Enrolled Population
Hide Arm/Group Description:
Overall enrolled population of patients: received at least one TAXUS Liberté Paclitaxel-Eluting Coronary Stent System in routine clinical practice, in conjunction with the use of prasugrel and aspirin.
Overall Number of Participants Analyzed 4059
Measure Type: Number
Unit of Measure: percentage of participants
0.1
22.Secondary Outcome
Title Rate of Myocardial Infarction (MI)
Hide Description -Binary rate
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
There were 67 patients that were not eligible for the 6-month analyses, as they did not meet the following criteria: either a minimum number of days of follow-up of 335 days or an endpoint event up to 365 days post-stent implant procedure.
Arm/Group Title TAXUS Liberté: Overall Enrolled Population
Hide Arm/Group Description:
Overall enrolled population of patients: received at least one TAXUS Liberté Paclitaxel-Eluting Coronary Stent System in routine clinical practice, in conjunction with the use of prasugrel and aspirin.
Overall Number of Participants Analyzed 4132
Measure Type: Number
Unit of Measure: percentage of participants
1.0
23.Secondary Outcome
Title Rate of Myocardial Infarction (MI)
Hide Description -Binary rate
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
There were 140 patients that were not eligible for the 12-month analyses, as they did not meet the following criteria: either a minimum number of days of follow-up of 335 days or an endpoint event up to 365 days post-stent implant procedure.
Arm/Group Title TAXUS Liberté: Overall Enrolled Population
Hide Arm/Group Description:
Overall enrolled population of patients: received at least one TAXUS Liberté Paclitaxel-Eluting Coronary Stent System in routine clinical practice, in conjunction with the use of prasugrel and aspirin.
Overall Number of Participants Analyzed 4059
Measure Type: Number
Unit of Measure: percentage of participants
1.4
24.Secondary Outcome
Title Rate of Myocardial Infarction (MI): Study Stent Related
Hide Description -Binary rate
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
There were 67 patients that were not eligible for the 6-month analyses, as they did not meet the following criteria: either a minimum number of days of follow-up of 335 days or an endpoint event up to 365 days post-stent implant procedure.
Arm/Group Title TAXUS Liberté: Overall Enrolled Population
Hide Arm/Group Description:
Overall enrolled population of patients: received at least one TAXUS Liberté Paclitaxel-Eluting Coronary Stent System in routine clinical practice, in conjunction with the use of prasugrel and aspirin.
Overall Number of Participants Analyzed 4132
Measure Type: Number
Unit of Measure: percentage of participants
0.9
25.Secondary Outcome
Title Rate of Myocardial Infarction (MI): Study Stent Related
Hide Description -Binary rate
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
There were 140 patients that were not eligible for the 12-month analyses, as they did not meet the following criteria: either a minimum number of days of follow-up of 335 days or an endpoint event up to 365 days post-stent implant procedure.
Arm/Group Title TAXUS Liberté: Overall Enrolled Population
Hide Arm/Group Description:
Overall enrolled population of patients: received at least one TAXUS Liberté Paclitaxel-Eluting Coronary Stent System in routine clinical practice, in conjunction with the use of prasugrel and aspirin.
Overall Number of Participants Analyzed 4059
Measure Type: Number
Unit of Measure: percentage of participants
1.0
26.Secondary Outcome
Title Rate of Target Vessel Reintervention (TVR)
Hide Description -Binary rate
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
There were 67 patients that were not eligible for the 6-month analyses, as they did not meet the following criteria: either a minimum number of days of follow-up of 335 days or an endpoint event up to 365 days post-stent implant procedure.
Arm/Group Title TAXUS Liberté: Overall Enrolled Population
Hide Arm/Group Description:
Overall enrolled population of patients: received at least one TAXUS Liberté Paclitaxel-Eluting Coronary Stent System in routine clinical practice, in conjunction with the use of prasugrel and aspirin.
Overall Number of Participants Analyzed 4132
Measure Type: Number
Unit of Measure: percentage of participants
3.3
27.Secondary Outcome
Title Rate of Target Vessel Reintervention (TVR)
Hide Description -Binary rate
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
There were 140 patients that were not eligible for the 12-month analyses, as they did not meet the following criteria: either a minimum number of days of follow-up of 335 days or an endpoint event up to 365 days post-stent implant procedure.
Arm/Group Title TAXUS Liberté: Overall Enrolled Population
Hide Arm/Group Description:
Overall enrolled population of patients: received at least one TAXUS Liberté Paclitaxel-Eluting Coronary Stent System in routine clinical practice, in conjunction with the use of prasugrel and aspirin.
Overall Number of Participants Analyzed 4059
Measure Type: Number
Unit of Measure: percentage of participants
5.8
28.Secondary Outcome
Title Rate of Target Vessel Reintervention (TVR): Study Stent Related
Hide Description -Binary rate
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
There were 67 patients that were not eligible for the 6-month analyses, as they did not meet the following criteria: either a minimum number of days of follow-up of 335 days or an endpoint event up to 365 days post-stent implant procedure.
Arm/Group Title TAXUS Liberté: Overall Enrolled Population
Hide Arm/Group Description:
Overall enrolled population of patients: received at least one TAXUS Liberté Paclitaxel-Eluting Coronary Stent System in routine clinical practice, in conjunction with the use of prasugrel and aspirin.
Overall Number of Participants Analyzed 4132
Measure Type: Number
Unit of Measure: percentage of participants
2.5
29.Secondary Outcome
Title Rate of Target Vessel Reintervention (TVR): Study Stent Related
Hide Description -Binary rate
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
There were 140 patients that were not eligible for the 12-month analyses, as they did not meet the following criteria: either a minimum number of days of follow-up of 335 days or an endpoint event up to 365 days post-stent implant procedure.
Arm/Group Title TAXUS Liberté: Overall Enrolled Population
Hide Arm/Group Description:
Overall enrolled population of patients: received at least one TAXUS Liberté Paclitaxel-Eluting Coronary Stent System in routine clinical practice, in conjunction with the use of prasugrel and aspirin.
Overall Number of Participants Analyzed 4059
Measure Type: Number
Unit of Measure: percentage of participants
4.3
30.Secondary Outcome
Title Rate of Stroke
Hide Description -Binary Rate
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
There were 67 patients that were not eligible for the 6-month analyses, as they did not meet the following criteria: either a minimum number of days of follow-up of 335 days or an endpoint event up to 365 days post-stent implant procedure.
Arm/Group Title TAXUS Liberté: Overall Enrolled Population
Hide Arm/Group Description:
Overall enrolled population of patients: received at least one TAXUS Liberté Paclitaxel-Eluting Coronary Stent System in routine clinical practice, in conjunction with the use of prasugrel and aspirin.
Overall Number of Participants Analyzed 4132
Measure Type: Number
Unit of Measure: percentage of participants
0.4
31.Secondary Outcome
Title Rate of Stroke
Hide Description -Binary Rate
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
There were 140 patients that were not eligible for the 12-month analyses, as they did not meet the following criteria: either a minimum number of days of follow-up of 335 days or an endpoint event up to 365 days post-stent implant procedure.
Arm/Group Title TAXUS Liberté: Overall Enrolled Population
Hide Arm/Group Description:
Overall enrolled population of patients: received at least one TAXUS Liberté Paclitaxel-Eluting Coronary Stent System in routine clinical practice, in conjunction with the use of prasugrel and aspirin.
Overall Number of Participants Analyzed 4059
Measure Type: Number
Unit of Measure: percentage of participants
0.5
32.Secondary Outcome
Title Rate of Major Bleeding
Hide Description
  • Major Bleeding defined as the composite of severe or moderate bleeding complication (based upon GUSTO classification).
  • Binary rate
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
There were 67 patients that were not eligible for the 6-month analyses, as they did not meet the following criteria: either a minimum number of days of follow-up of 335 days or an endpoint event up to 365 days post-stent implant procedure.
Arm/Group Title TAXUS Liberté: Overall Enrolled Population
Hide Arm/Group Description:
Overall enrolled population of patients: received at least one TAXUS Liberté Paclitaxel-Eluting Coronary Stent System in routine clinical practice, in conjunction with the use of prasugrel and aspirin.
Overall Number of Participants Analyzed 4132
Measure Type: Number
Unit of Measure: percentage of participants
2.3
33.Secondary Outcome
Title Rate of Major Bleeding
Hide Description
  • Major Bleeding defined as the composite of severe or moderate bleeding complication (based upon GUSTO classification).
  • Binary rate
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
There were 140 patients that were not eligible for the 12-month analyses, as they did not meet the following criteria: either a minimum number of days of follow-up of 335 days or an endpoint event up to 365 days post-stent implant procedure.
Arm/Group Title TAXUS Liberté: Overall Enrolled Population
Hide Arm/Group Description:
Overall enrolled population of patients: received at least one TAXUS Liberté Paclitaxel-Eluting Coronary Stent System in routine clinical practice, in conjunction with the use of prasugrel and aspirin.
Overall Number of Participants Analyzed 4059
Measure Type: Number
Unit of Measure: percentage of participants
3.6
34.Secondary Outcome
Title Rate of Stent Thrombosis (ARC Definite + Probable)
Hide Description
  • ARC - Academic Research Consortium
  • Binary rate
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
There were 67 patients that were not eligible for the 6-month analyses, as they did not meet the following criteria: either a minimum number of days of follow-up of 335 days or an endpoint event up to 365 days post-stent implant procedure.
Arm/Group Title TAXUS Liberté: Overall Enrolled Population
Hide Arm/Group Description:
Overall enrolled population of patients: received at least one TAXUS Liberté Paclitaxel-Eluting Coronary Stent System in routine clinical practice, in conjunction with the use of prasugrel and aspirin.
Overall Number of Participants Analyzed 4132
Measure Type: Number
Unit of Measure: percentage of participants
0.6
35.Secondary Outcome
Title Rate of Stent Thrombosis (ARC Definite + Probable)
Hide Description
  • ARC - Academic Research Consortium
  • Binary Rate
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
There were 140 patients that were not eligible for the 12-month analyses, as they did not meet the following criteria: either a minimum number of days of follow-up of 335 days or an endpoint event up to 365 days post-stent implant procedure.
Arm/Group Title TAXUS Liberté: Overall Enrolled Population
Hide Arm/Group Description:
Overall enrolled population of patients: received at least one TAXUS Liberté Paclitaxel-Eluting Coronary Stent System in routine clinical practice, in conjunction with the use of prasugrel and aspirin.
Overall Number of Participants Analyzed 4059
Measure Type: Number
Unit of Measure: percentage of participants
0.8
36.Secondary Outcome
Title Rate of Stent Thrombosis (Protocol Definition)
Hide Description

-Binary rate

The occurrence of any of the following:

  1. Clinical presentation of acute coronary syndrome with angiographic evidence of stent thrombosis:

    Angiographic documentation of acute complete occlusion (TIMI flow 0 or 1) of a previously successfully treated artery (TIMI flow 2 to 3 immediately after stent placement and diameter stenosis less than or equal to 30%) and/or Angiographic documentation of a flow limiting thrombus within or adjacent to a previously successfully treated lesion

  2. Acute MI in the distribution of the treated vessel.
  3. Death within the first 30 days post index procedure (without other obvious cause) is considered a surrogate for stent thrombosis when angiography is not available.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
There were 67 patients that were not eligible for the 6-month analyses, as they did not meet the following criteria: either a minimum number of days of follow-up of 335 days or an endpoint event up to 365 days post-stent implant procedure.
Arm/Group Title TAXUS Liberté: Overall Enrolled Population
Hide Arm/Group Description:
Overall enrolled population of patients: received at least one TAXUS Liberté Paclitaxel-Eluting Coronary Stent System in routine clinical practice, in conjunction with the use of prasugrel and aspirin.
Overall Number of Participants Analyzed 4132
Measure Type: Number
Unit of Measure: percentage of participants
0.6
37.Secondary Outcome
Title Rate of Stent Thrombosis (Protocol Definition)
Hide Description

-Binary rate

The occurrence of any of the following:

  1. Clinical presentation of acute coronary syndrome with angiographic evidence of stent thrombosis:

    Angiographic documentation of acute complete occlusion (TIMI flow 0 or 1) of a previously successfully treated artery (TIMI flow 2 to 3 immediately after stent placement and diameter stenosis less than or equal to 30%) and/or Angiographic documentation of a flow limiting thrombus within or adjacent to a previously successfully treated lesion

  2. Acute MI in the distribution of the treated vessel.
  3. Death within the first 30 days post index procedure (without other obvious cause) is considered a surrogate for stent thrombosis when angiography is not available.
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
There were 140 patients that were not eligible for the 12-month analyses, as they did not meet the following criteria: either a minimum number of days of follow-up of 335 days or an endpoint event up to 365 days post-stent implant procedure.
Arm/Group Title TAXUS Liberté: Overall Enrolled Population
Hide Arm/Group Description:
Overall enrolled population of patients: received at least one TAXUS Liberté Paclitaxel-Eluting Coronary Stent System in routine clinical practice, in conjunction with the use of prasugrel and aspirin.
Overall Number of Participants Analyzed 4059
Measure Type: Number
Unit of Measure: percentage of participants
0.9
Time Frame 1 year
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title TAXUS Liberté: Overall Enrolled Population
Hide Arm/Group Description Overall enrolled population of patients: received at least one TAXUS Liberté Paclitaxel-Eluting Coronary Stent System in routine clinical practice, in conjunction with the use of prasugrel and aspirin.
All-Cause Mortality
TAXUS Liberté: Overall Enrolled Population
Affected / at Risk (%)
Total   --/--    
Hide Serious Adverse Events
TAXUS Liberté: Overall Enrolled Population
Affected / at Risk (%) # Events
Total   1232/4199 (29.34%)    
Blood and lymphatic system disorders   
Anaemia  1  27/4199 (0.64%)  28
Iron deficiency anaemia  1  5/4199 (0.12%)  5
Microcytic anaemia  1  2/4199 (0.05%)  3
Normochromic normocytic anaemia  1  2/4199 (0.05%)  3
Thrombocytopenic purpura  1  1/4199 (0.02%)  2
Anaemic haemolytic autoimmune  1  1/4199 (0.02%)  1
Heparin-induced thrombocytopenia  1  1/4199 (0.02%)  1
Leukocytosis  1  1/4199 (0.02%)  1
Platelet aggregation inhibition  1  1/4199 (0.02%)  1
Thrombocytopenia  1  1/4199 (0.02%)  1
Haemorrhagic anaemia  1  12/4199 (0.29%)  12
Cardiac disorders   
Angina pectoris  1  253/4199 (6.03%)  278
Angina unstable  1  100/4199 (2.38%)  113
Coronary artery disease  1  77/4199 (1.83%)  79
Cardiac failure congestive  1  48/4199 (1.14%)  62
Coronary artery stenosis  1  50/4199 (1.19%)  51
Acute myocardial infarction  1  46/4199 (1.10%)  50
Myocardial infarction  1  45/4199 (1.07%)  48
Atrial fibrillation  1  22/4199 (0.52%)  26
Coronary artery thrombosis  1  21/4199 (0.50%)  24
Ventricular tachycardia  1  16/4199 (0.38%)  16
Cardiac arrest  1  15/4199 (0.36%)  15
Coronary artery dissection  1  14/4199 (0.33%)  15
Ischaemic cardiomyopathy  1  12/4199 (0.29%)  12
Myocardial ischaemia  1  12/4199 (0.29%)  12
Bradycardia  1  11/4199 (0.26%)  11
Ventricular fibrillation  1  10/4199 (0.24%)  10
Acute coronary syndrome  1  6/4199 (0.14%)  6
Cardiac failure  1  6/4199 (0.14%)  6
Coronary artery occlusion  1  5/4199 (0.12%)  5
Supraventricular tachycardia  1  5/4199 (0.12%)  5
Atrioventricular block complete  1  4/4199 (0.10%)  4
Sick sinus syndrome  1  4/4199 (0.10%)  4
Arteriosclerosis coronary artery  1  3/4199 (0.07%)  3
Cardiac failure chronic  1  3/4199 (0.07%)  3
Cardiorespiratory arrest  1  3/4199 (0.07%)  3
Cardiomyopathy  1  3/4199 (0.07%)  3
Congestive myopathy  1  3/4199 (0.07%)  3
Left ventricular dysfunction  1  3/4199 (0.07%)  3
Arteriospasm coronary  1  2/4199 (0.05%)  2
Atrioventricular block  1  2/4199 (0.05%)  2
Cardiac tamponade  1  2/4199 (0.05%)  2
Cardiogenic Shock  1  2/4199 (0.05%)  2
Coronary artery perforation  1  2/4199 (0.05%)  2
Mitral valve incompetence  1  2/4199 (0.05%)  2
Palpitations  1  2/4199 (0.05%)  2
Aortic Valve Stenosis  1  1/4199 (0.02%)  1
Atrial tachycardia  1  1/4199 (0.02%)  1
Atrioventricular block first degree  1  1/4199 (0.02%)  1
Cardiac aneurysm  1  1/4199 (0.02%)  1
Cardiac disorder  1  1/4199 (0.02%)  1
Cardiac failure acute  1  1/4199 (0.02%)  1
Cardiopulmonary failure  1  1/4199 (0.02%)  1
Conduction Disorder  1  1/4199 (0.02%)  1
Hypertensive heart disease  1  1/4199 (0.02%)  1
Hypertrophic cardiomyopathy  1  1/4199 (0.02%)  1
Intracardiac thrombus  1  1/4199 (0.02%)  1
Left ventricular failure  1  1/4199 (0.02%)  1
Microvascular angina  1  1/4199 (0.02%)  1
Pericarditis  1  1/4199 (0.02%)  1
Postural orthostatic tachycardia syndrome  1  1/4199 (0.02%)  1
Sinus tachycardia  1  1/4199 (0.02%)  1
Stress cardiomyopathy  1  1/4199 (0.02%)  1
Tachycardia  1  1/4199 (0.02%)  1
Ventricle Rupture  1  1/4199 (0.02%)  1
Ventricular dysfunction  1  1/4199 (0.02%)  1
Gastritis Haemorrhagic  1  3/4199 (0.07%)  3
Congenital, familial and genetic disorders   
Haemorrhagic arteriovenous malformation  1  2/4199 (0.05%)  3
Atrial septal defect  1  2/4199 (0.05%)  2
Ear and labyrinth disorders   
Vertigo  1  2/4199 (0.05%)  2
Endocrine disorders   
Primary hypothyroidism  1  1/4199 (0.02%)  1
Eye disorders   
Retinal artery occlusion  1  1/4199 (0.02%)  1
Retinal detachment  1  1/4199 (0.02%)  1
Gastrointestinal disorders   
Gastrointestinal haemorrhage  1  51/4199 (1.21%)  57
Rectal haemorrhage  1  10/4199 (0.24%)  10
Upper gastrointestinal haemorrhage  1  9/4199 (0.21%)  9
Lower gastrointestinal haemorrhage  1  8/4199 (0.19%)  8
Gastritis  1  7/4199 (0.17%)  7
Pancreatitis  1  6/4199 (0.14%)  6
Pancreatitis acute  1  3/4199 (0.07%)  5
Retroperitoneal haemorrhage  1  5/4199 (0.12%)  5
Small intestinal obstruction  1  5/4199 (0.12%)  5
Abdominal pain  1  4/4199 (0.10%)  4
Gastroesophageal reflux disease  1  4/4199 (0.10%)  4
Haematemesis  1  4/4199 (0.10%)  4
Peptic ulcer  1  3/4199 (0.07%)  3
Abdominal pain upper  1  2/4199 (0.05%)  2
Colitis ischaemic  1  2/4199 (0.05%)  2
Diabetic gastroparesis  1  1/4199 (0.02%)  2
Duodenal ulcer haemorrhage  1  2/4199 (0.05%)  2
Gastric ulcer  1  2/4199 (0.05%)  2
Gastritis erosive  1  2/4199 (0.05%)  2
Haemorrhoidal haemorrhage  1  2/4199 (0.05%)  2
Impaired gastric emptying  1  2/4199 (0.05%)  2
Nausea  1  2/4199 (0.05%)  2
Retroperitoneal haematoma  1  2/4199 (0.05%)  2
Abdominal distension  1  1/4199 (0.02%)  1
Abdominal hernia  1  1/4199 (0.02%)  1
Abdominal pain lower  1  1/4199 (0.02%)  1
Colitis  1  1/4199 (0.02%)  1
Colitis ulcerative  1  1/4199 (0.02%)  1
Diarrhoea  1  1/4199 (0.02%)  1
Diverticulum  1  1/4199 (0.02%)  1
Diverticulum intestinal  1  1/4199 (0.02%)  1
Duodenal ulcer  1  1/4199 (0.02%)  1
Entercolitis haemorrhagic  1  1/4199 (0.02%)  1
Gastric ulcer haemorrhage  1  1/4199 (0.02%)  1
Gastrointestinal ulcer  1  1/4199 (0.02%)  1
Gastrointestinal ulcer haemorrhage  1  1/4199 (0.02%)  1
Hiatus hernia  1  1/4199 (0.02%)  1
Ileus paralytic  1  1/4199 (0.02%)  1
Inguinal hernia  1  1/4199 (0.02%)  1
Intra-abdominal haemorrhage  1  1/4199 (0.02%)  1
Lip haemorrhage  1  1/4199 (0.02%)  1
Localised intraabdominal fluid collection  1  1/4199 (0.02%)  1
Mallory-Weiss syndrome  1  1/4199 (0.02%)  1
Melaena  1  1/4199 (0.02%)  1
Obstruction gastric  1  1/4199 (0.02%)  1
Oesophageal rupture  1  1/4199 (0.02%)  1
Oesophageal ulcer  1  1/4199 (0.02%)  1
Oesophageal ulcer haemorrhage  1  1/4199 (0.02%)  1
Oesophageal varices haemorrhage  1  1/4199 (0.02%)  1
Pancreatic cyst  1  1/4199 (0.02%)  1
Pancreatic pseudocyst  1  1/4199 (0.02%)  1
Pacreatitis chronic  1  1/4199 (0.02%)  1
Peptic ulcer haemorrhage  1  1/4199 (0.02%)  1
Peptic ulcer perforation  1  1/4199 (0.02%)  1
Peritoneal haemorrhage  1  1/4199 (0.02%)  1
Peritonitis  1  1/4199 (0.02%)  1
Proctitis  1  1/4199 (0.02%)  1
Rectal ulcer haemorrhage  1  1/4199 (0.02%)  1
Small intestine perforation  1  1/4199 (0.02%)  1
Umbilical hernia  1  1/4199 (0.02%)  1
Vomiting  1  1/4199 (0.02%)  1
General disorders   
Non-cardiac chest pain  1  160/4199 (3.81%)  183
Chest pain  1  20/4199 (0.48%)  23
Catheter site haemorrhage  1  6/4199 (0.14%)  7
Adverse drug reaction  1  6/4199 (0.14%)  6
Catheter site haematoma  1  6/4199 (0.14%)  6
Death  1  4/4199 (0.10%)  4
Asthenia  1  3/4199 (0.07%)  3
Chest discomfort  1  2/4199 (0.05%)  2
Impaired healing  1  2/4199 (0.05%)  2
Multi-organ failure  1  2/4199 (0.05%)  2
Pyrexia  1  2/4199 (0.05%)  2
Catheter site discharge  1  1/4199 (0.02%)  1
Catheter site pain  1  1/4199 (0.02%)  1
Hepatobiliary disorders   
Cholecystitis acute  1  7/4199 (0.17%)  7
Cholecystitis  1  5/4199 (0.12%)  6
Cholelithiasis  1  4/4199 (0.10%)  4
Biliary dyskinesia  1  2/4199 (0.05%)  2
Bile duct obstruction  1  1/4199 (0.02%)  1
Bile duct stenosis  1  1/4199 (0.02%)  1
Bile duct stone  1  1/4199 (0.02%)  1
Gallbladder disorder  1  1/4199 (0.02%)  1
Immune system disorders   
Drug hypersensitivity  1  4/4199 (0.10%)  4
Hypersensitivity  1  3/4199 (0.07%)  3
Infections and infestations   
Pneumonia  1  29/4199 (0.69%)  30
Cellulitis  1  13/4199 (0.31%)  15
Bronchitis  1  7/4199 (0.17%)  7
Sepsis  1  7/4199 (0.17%)  7
Appendicitis  1  5/4199 (0.12%)  5
Diverticulitis  1  3/4199 (0.07%)  5
Abscess Limb  1  4/4199 (0.10%)  4
Gastroenteritis  1  3/4199 (0.07%)  3
Urinary Tract Infection  1  3/4199 (0.07%)  3
Cellulitis staphylococcal  1  1/4199 (0.02%)  2
Diabetic foot infection  1  2/4199 (0.05%)  2
Gangrene  1  2/4199 (0.05%)  2
Influenza  1  2/4199 (0.05%)  2
Lobar pneumonia  1  2/4199 (0.05%)  2
Osteomyelitis  1  2/4199 (0.05%)  2
Pneumonia staphylococcal  1  2/4199 (0.05%)  2
Septic shock  1  2/4199 (0.05%)  2
Sinusitis  1  2/4199 (0.05%)  2
Staphylococcal infection  1  2/4199 (0.05%)  2
Urosepsis  1  2/4199 (0.05%)  2
Wound infection  1  2/4199 (0.05%)  2
Abdominal wall access  1  1/4199 (0.02%)  1
Abdominal wall infection  1  1/4199 (0.02%)  1
Abscess intestinal  1  1/4199 (0.02%)  1
Bronchopneumonia  1  1/4199 (0.02%)  1
Bronchopulmonary aspergillosis allergic  1  1/4199 (0.02%)  1
Device related infection  1  1/4199 (0.02%)  1
Empyema  1  1/4199 (0.02%)  1
Fungal infection  1  1/4199 (0.02%)  1
Groin infection  1  1/4199 (0.02%)  1
Herpes zoster  1  1/4199 (0.02%)  1
Infected lymphocyle  1  1/4199 (0.02%)  1
Infected skin ulcer  1  1/4199 (0.02%)  1
Infection  1  1/4199 (0.02%)  1
Pneumonia bacterial  1  1/4199 (0.02%)  1
Pneumonia pneumococcal  1  1/4199 (0.02%)  1
Pyelonephritis  1  1/4199 (0.02%)  1
Rectal abcess  1  1/4199 (0.02%)  1
Scrotal abcess  1  1/4199 (0.02%)  1
Sepsis syndrome  1  1/4199 (0.02%)  1
Staphylococcal bacteraemia  1  1/4199 (0.02%)  1
Steptococcal sepsis  1  1/4199 (0.02%)  1
Thrombophlebitis septic  1  1/4199 (0.02%)  1
Tracheobronchitis  1  1/4199 (0.02%)  1
Upper respiritory tract infection  1  1/4199 (0.02%)  1
Injury, poisoning and procedural complications   
Vascular pseudoaneurysm  1  16/4199 (0.38%)  16
Ankle fracture  1  3/4199 (0.07%)  4
Contusion  1  4/4199 (0.10%)  4
Hip fracture  1  4/4199 (0.10%)  4
Subdural haematoma  1  3/4199 (0.07%)  4
Overdose  1  3/4199 (0.07%)  3
Post procedural myocardial infarction  1  3/4199 (0.07%)  3
Anaemia postoperative  1  2/4199 (0.05%)  2
Device malfunction  1  2/4199 (0.05%)  2
Foot fracture  1  2/4199 (0.05%)  2
Head injury  1  2/4199 (0.05%)  2
Lower limb fracture  1  2/4199 (0.05%)  2
Post procedural haemorrhage  1  2/4199 (0.05%)  2
Rib fracture  1  2/4199 (0.05%)  2
Anastamotic ulcer haemorrhage  1  1/4199 (0.02%)  1
Burns third degree  1  1/4199 (0.02%)  1
Contrast media reaction  1  1/4199 (0.02%)  1
Device lead damage  1  1/4199 (0.02%)  1
Facial bones fracture  1  1/4199 (0.02%)  1
Fibula fracture  1  1/4199 (0.02%)  1
Incision site haematoma  1  1/4199 (0.02%)  1
Incision site pain  1  1/4199 (0.02%)  1
Incisional hernia  1  1/4199 (0.02%)  1
Joint injury  1  1/4199 (0.02%)  1
Laceration  1  1/4199 (0.02%)  1
Mouth injury  1  1/4199 (0.02%)  1
Poisoning  1  1/4199 (0.02%)  1
Post procedural complication  1  1/4199 (0.02%)  1
Road traffic accident  1  1/4199 (0.02%)  1
Scrotal haematoma  1  1/4199 (0.02%)  1
Skin laceration  1  1/4199 (0.02%)  1
Spinal compression fracture  1  1/4199 (0.02%)  1
Splenic rupture  1  1/4199 (0.02%)  1
Thermal burn  1  1/4199 (0.02%)  1
Tibia fracture  1  1/4199 (0.02%)  1
Traumatic lung injury  1  1/4199 (0.02%)  1
Vascular procedure complication  1  1/4199 (0.02%)  1
Investigations   
Cardiac enzymes increased  1  4/4199 (0.10%)  4
Haemoglobin decreased  1  4/4199 (0.10%)  4
Bacteria stool identified  1  1/4199 (0.02%)  1
Blood glucose decreased  1  1/4199 (0.02%)  1
Cardiac stress test abnormal  1  1/4199 (0.02%)  1
Electrocardiogram abnormal  1  1/4199 (0.02%)  1
Troponin increased  1  1/4199 (0.02%)  1
Metabolism and nutrition disorders   
Dehydration  1  3/4199 (0.07%)  3
Diabetes mellitus inadequate control  1  2/4199 (0.05%)  2
Fluid overload  1  1/4199 (0.02%)  2
Gout  1  2/4199 (0.05%)  2
Hyperglycaemia  1  2/4199 (0.05%)  2
Type 2 diabetes mellitus  1  2/4199 (0.05%)  2
Diabetes mellitus  1  1/4199 (0.02%)  1
Diabetic foot  1  1/4199 (0.02%)  1
Diabetic ketoacidosis  1  1/4199 (0.02%)  1
Failure to thrive  1  1/4199 (0.02%)  1
Hyperkalaemia  1  1/4199 (0.02%)  1
Hypoglycaemia  1  1/4199 (0.02%)  1
Hypokalaemia  1  1/4199 (0.02%)  1
Hypomagnesaemia  1  1/4199 (0.02%)  1
Malnutrition  1  1/4199 (0.02%)  1
Metabolic acidosis  1  1/4199 (0.02%)  1
Obesity  1  1/4199 (0.02%)  1
Vitamin D deficiency  1  1/4199 (0.02%)  1
Musculoskeletal and connective tissue disorders   
Osteoarthritis  1  7/4199 (0.17%)  7
Musculoskeletal chest pain  1  4/4199 (0.10%)  5
Intervertebral disc protrusion  1  4/4199 (0.10%)  4
Back Pain  1  3/4199 (0.07%)  3
Pain in extremity  1  3/4199 (0.07%)  3
Arthralgia  1  2/4199 (0.05%)  2
Costochondritis  1  2/4199 (0.05%)  2
Muscular weakness  1  2/4199 (0.05%)  2
Musculoskeletal pain  1  2/4199 (0.05%)  2
Rotator cuff syndrome  1  2/4199 (0.05%)  2
Arthritis  1  1/4199 (0.02%)  1
Arthrofibrosis  1  1/4199 (0.02%)  1
Bursitis  1  1/4199 (0.02%)  1
Cervical spinal stenosis  1  1/4199 (0.02%)  1
Lumbar spinal stenosis  1  1/4199 (0.02%)  1
Neck pain  1  1/4199 (0.02%)  1
Spinal column stenosis  1  1/4199 (0.02%)  1
Spinal osteoarthritis  1  1/4199 (0.02%)  1
Spondylolisthesis  1  1/4199 (0.02%)  1
Systemic lupus erythematosus  1  1/4199 (0.02%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Colon cancer  1  4/4199 (0.10%)  5
Prostate cancer  1  3/4199 (0.07%)  3
Bladder cancer  1  2/4199 (0.05%)  2
Bladder transitional cell carcinoma  1  2/4199 (0.05%)  2
Breast cancer  1  2/4199 (0.05%)  2
Lung neoplasm malignant  1  2/4199 (0.05%)  2
Pancreatic carcinoma  1  2/4199 (0.05%)  2
Benign neoplasm of bladder  1  1/4199 (0.02%)  1
Gastrointestinal cancer metastatic  1  1/4199 (0.02%)  1
Hepatic cancer stage IV  1  1/4199 (0.02%)  1
Intestinal adenocarcenoma  1  1/4199 (0.02%)  1
Leukaemia recurrent  1  1/4199 (0.02%)  1
Lung adenocarcinoma metastatic  1  1/4199 (0.02%)  1
Lung adenocarcinoma stage IV  1  1/4199 (0.02%)  1
Lung squamous cell carcinoma stage 1  1  1/4199 (0.02%)  1
Lung squamous cell carcinoma stage III  1  1/4199 (0.02%)  1
Lung squamous cell carcinoma stage unspecified  1  1/4199 (0.02%)  1
Metastases to liver  1  1/4199 (0.02%)  1
Multiple myeloma  1  1/4199 (0.02%)  1
Neoplasm  1  1/4199 (0.02%)  1
Non-small cell lung cancer metastatic  1  1/4199 (0.02%)  1
Oesophageal adenocarcinoma  1  1/4199 (0.02%)  1
Oesophageal carcinoma  1  1/4199 (0.02%)  1
Pharyngeal cancer stage unspecified  1  1/4199 (0.02%)  1
Prostate cancer metastatic  1  1/4199 (0.02%)  1
Rectal cancer  1  1/4199 (0.02%)  1
Rectal cancer metastatic  1  1/4199 (0.02%)  1
Renal cancer carcinoma  1  1/4199 (0.02%)  1
Squamous cell carcinoma  1  1/4199 (0.02%)  1
Thyroid cancer  1  1/4199 (0.02%)  1
Uterine leiomyoma  1  1/4199 (0.02%)  1
Nervous system disorders   
Syncope  1  20/4199 (0.48%)  23
Carotic artery stenosis  1  13/4199 (0.31%)  14
Ischaemic stroke  1  11/4199 (0.26%)  11
Transient ischaemic attack  1  8/4199 (0.19%)  8
Presyncope  1  6/4199 (0.14%)  6
Haemorrhage intracranial  1  4/4199 (0.10%)  4
Dizziness  1  3/4199 (0.07%)  3
Embolic stroke  1  3/4199 (0.07%)  3
Subarachnoid haemorrhage  1  3/4199 (0.07%)  3
Carotid sinus syndrome  1  1/4199 (0.02%)  2
Cerebral haemorrhage  1  2/4199 (0.05%)  2
Cerebral infarction  1  2/4199 (0.05%)  2
Convulsion  1  2/4199 (0.05%)  2
Neuropathy peripheral  1  2/4199 (0.05%)  2
Paraesthesia  1  2/4199 (0.05%)  2
Amnesia  1  1/4199 (0.02%)  1
Anoxic encephalopathy  1  1/4199 (0.02%)  1
Basilar artery thrombosis  1  1/4199 (0.02%)  1
Brain stem infarction  1  1/4199 (0.02%)  1
Burning sensation  1  1/4199 (0.02%)  1
Carotic artery occlusion  1  1/4199 (0.02%)  1
Cerebrovascular accident  1  1/4199 (0.02%)  1
Cervicobrachial syndrome  1  1/4199 (0.02%)  1
Encephalopathy  1  1/4199 (0.02%)  1
Facial palsy  1  1/4199 (0.02%)  1
Guillain-Barre syndrome  1  1/4199 (0.02%)  1
Hemianopia homonymous  1  1/4199 (0.02%)  1
Hemiparesis  1  1/4199 (0.02%)  1
Hepatic encephalopathy  1  1/4199 (0.02%)  1
Hydrocephalus  1  1/4199 (0.02%)  1
Hypertensive encephalopathy  1  1/4199 (0.02%)  1
Lacunar infarction  1  1/4199 (0.02%)  1
Lumbar radiculopathy  1  1/4199 (0.02%)  1
Rapiculopathy  1  1/4199 (0.02%)  1
Tarsal tunnel syndrome  1  1/4199 (0.02%)  1
Thrombotic stroke  1  1/4199 (0.02%)  1
Transient global amnesia  1  1/4199 (0.02%)  1
Vertobasilar insufficiency  1  1/4199 (0.02%)  1
Psychiatric disorders   
Mental status changes  1  5/4199 (0.12%)  5
Alcohol withdrawal syndrome  1  2/4199 (0.05%)  2
Suicidal ideation  1  2/4199 (0.05%)  2
Anxiety  1  1/4199 (0.02%)  1
Completed suicide  1  1/4199 (0.02%)  1
Confusional state  1  1/4199 (0.02%)  1
Psychotic disorder  1  1/4199 (0.02%)  1
Renal and urinary disorders   
Renal failure acute  1  17/4199 (0.40%)  18
Renal failure  1  7/4199 (0.17%)  7
Haematuria  1  6/4199 (0.14%)  6
Nephrolithiasis  1  3/4199 (0.07%)  3
Renal artery stenosis  1  3/4199 (0.07%)  3
Nephrotic syndrome  1  1/4199 (0.02%)  2
Pelvi-ureteric obstruction  1  2/4199 (0.05%)  2
Renal failure chronic  1  2/4199 (0.05%)  2
Renal impairment  1  2/4199 (0.05%)  2
Calculus ureteric  1  1/4199 (0.02%)  1
Cystitis haemorrhagic  1  1/4199 (0.02%)  1
Urethral haemorrhagic  1  1/4199 (0.02%)  1
Reproductive system and breast disorders   
Menorrhagia  1  3/4199 (0.07%)  3
Uterine prolapse  1  1/4199 (0.02%)  1
Vaginal haemorrhage  1  1/4199 (0.02%)  1
Vaginal prolapse  1  1/4199 (0.02%)  1
Respiratory, thoracic and mediastinal disorders   
Chronic obstruction pulmonary disease  1  13/4199 (0.31%)  17
Dyspnoea  1  12/4199 (0.29%)  15
Acute respiratory failure  1  10/4199 (0.24%)  10
Pulmonary embolism  1  9/4199 (0.21%)  9
Epistaxis  1  6/4199 (0.14%)  7
Respiratory failure  1  6/4199 (0.14%)  6
Pleural effusion  1  2/4199 (0.05%)  3
Acute pulmonary oedema  1  2/4199 (0.05%)  2
Haemoptysis  1  2/4199 (0.05%)  2
Pleuritic pain  1  2/4199 (0.05%)  2
Asthma  1  1/4199 (0.02%)  1
Bronchitis chronic  1  1/4199 (0.02%)  1
Dyspnoea exertional  1  1/4199 (0.02%)  1
Hypoxia  1  1/4199 (0.02%)  1
Interstitial lung disease  1  1/4199 (0.02%)  1
Lung infiltration  1  1/4199 (0.02%)  1
Pleurisy  1  1/4199 (0.02%)  1
Pulmonary alveolar haemorrhage  1  1/4199 (0.02%)  1
Pulmonary fibrosis  1  1/4199 (0.02%)  1
Pulmonary hypertension  1  1/4199 (0.02%)  1
Pulmonary oedema  1  1/4199 (0.02%)  1
Respiratory arrest  1  1/4199 (0.02%)  1
Status asthmaticus  1  1/4199 (0.02%)  1
Skin and subcutaneous tissue disorders   
Angioedema  1  2/4199 (0.05%)  2
Skin ulcer  1  2/4199 (0.05%)  2
Stevens-Johnson syndrome  1  1/4199 (0.02%)  1
Vascular disorders   
Peripheral arterial occlusive disease  1  8/4199 (0.19%)  11
Peripheral vascular disorder  1  10/4199 (0.24%)  10
Deep vein thrombosis  1  7/4199 (0.17%)  8
Hypertension  1  8/4199 (0.19%)  8
Hypotension  1  8/4199 (0.19%)  8
Intermittent claudication  1  6/4199 (0.14%)  7
Aortic stenosis  1  5/4199 (0.12%)  5
Orthostatic hypotension  1  5/4199 (0.12%)  5
Femoral arterial stenosis  1  4/4199 (0.10%)  4
Iliac artery stenosis  1  4/4199 (0.10%)  4
Peripheral ischaemia  1  4/4199 (0.10%)  4
Femoral artery occlusion  1  3/4199 (0.07%)  3
Haematoma  1  2/4199 (0.05%)  2
Hypertensive crisis  1  2/4199 (0.05%)  2
Malignant hypertension  1  2/4199 (0.05%)  2
Peripheral artery aneurysm  1  2/4199 (0.05%)  2
Vasospasm  1  1/4199 (0.02%)  2
Aortic aneurysm  1  1/4199 (0.02%)  1
Arterial fibrosis  1  1/4199 (0.02%)  1
Arterial haemorrhage  1  1/4199 (0.02%)  1
Arterial stenosis  1  1/4199 (0.02%)  1
Arterial stenosis limb  1  1/4199 (0.02%)  1
Arterial thrombosis limb  1  1/4199 (0.02%)  1
Arteriosclerosis  1  1/4199 (0.02%)  1
Blue toe syndrome  1  1/4199 (0.02%)  1
Haemorrhage  1  1/4199 (0.02%)  1
Hypertensive emergency  1  1/4199 (0.02%)  1
Iliac artery occlusion  1  1/4199 (0.02%)  1
Peripheral artery dissection  1  1/4199 (0.02%)  1
Subclavian artery stenosis  1  1/4199 (0.02%)  1
Venous stenosis  1  1/4199 (0.02%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 12.1
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
TAXUS Liberté: Overall Enrolled Population
Affected / at Risk (%) # Events
Total   293/4199 (6.98%)    
Blood and lymphatic system disorders   
Anaemia  1  6/4199 (0.14%)  6
Iron deficiency anaemia  1  1/4199 (0.02%)  1
Cardiac disorders   
Myocardial infarction  1  43/4199 (1.02%)  43
Coronary artery disease  1  21/4199 (0.50%)  21
Coronary artery dissection  1  7/4199 (0.17%)  7
Acute myocardial infarction  1  2/4199 (0.05%)  2
Angina pectoris  1  1/4199 (0.02%)  1
Angina unstable  1  1/4199 (0.02%)  1
Coronary artery stenosis  1  1/4199 (0.02%)  1
Coronary artery thrombosis  1  1/4199 (0.02%)  1
Eye disorders   
Conjunctival haemorrhage  1  2/4199 (0.05%)  2
Hyphaema  1  1/4199 (0.02%)  1
Gastrointestinal disorders   
Rectal haemorrhage  1  9/4199 (0.21%)  9
Gastrointestinal haemorrhage  1  8/4199 (0.19%)  8
Gingival bleeding  1  4/4199 (0.10%)  4
Abdominal discomfort  1  3/4199 (0.07%)  3
Haematochezia  1  3/4199 (0.07%)  3
Melaena  1  3/4199 (0.07%)  3
Faeces discoloured  1  2/4199 (0.05%)  2
Diarrhoea  1  1/4199 (0.02%)  1
Gastric ulcer  1  1/4199 (0.02%)  1
Haemorrhoidal haemorrhage  1  1/4199 (0.02%)  1
Nausea  1  1/4199 (0.02%)  1
Upper gastrointestinal haemorrhage  1  1/4199 (0.02%)  1
General disorders   
Adverse drug reaction  1  20/4199 (0.48%)  20
Catheter site haematoma  1  7/4199 (0.17%)  7
Catheter site haemorrhage  1  2/4199 (0.05%)  2
Chest pain  1  2/4199 (0.05%)  2
Catheter site discharge  1  1/4199 (0.02%)  1
Catheter site related reaction  1  1/4199 (0.02%)  1
Chest discomfort  1  1/4199 (0.02%)  1
Non-cardiac chest pain  1  1/4199 (0.02%)  1
Puncture site haemorrhage  1  1/4199 (0.02%)  1
Immune system disorders   
Drug hypersensitivity  1  19/4199 (0.45%)  19
Hypersensitivity  1  4/4199 (0.10%)  4
Injury, poisoning and procedural complications   
Post-procedure myocardial infarction  1  9/4199 (0.21%)  9
Contusion  1  8/4199 (0.19%)  8
Animal scratch  1  1/4199 (0.02%)  1
Limb injury  1  1/4199 (0.02%)  1
Post procedural haemorrhage  1  1/4199 (0.02%)  1
Subdural haematoma  1  1/4199 (0.02%)  1
Tongue injury  1  1/4199 (0.02%)  1
Vascular procedure complication  1  1/4199 (0.02%)  1
Vascular pseudoaneurysm  1  1/4199 (0.02%)  1
Venous injury  1  1/4199 (0.02%)  1
Investigations   
Cardiac enzymes increased  1  5/4199 (0.12%)  5
Troponin increased  1  5/4199 (0.12%)  5
Bleeding time prolonged  1  1/4199 (0.02%)  1
Blood creatine phosphokinase MB increased  1  1/4199 (0.02%)  1
Haemoglobin decreased  1  1/4199 (0.02%)  1
Musculoskeletal and connective tissue disorders   
Myalgia  1  1/4199 (0.02%)  2
Joint effusion  1  1/4199 (0.02%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Bladder cancer recurrent  1  1/4199 (0.02%)  1
Nervous system disorders   
Transient ischaemic attack  1  2/4199 (0.05%)  2
Dizziness  1  1/4199 (0.02%)  1
Headache  1  1/4199 (0.02%)  1
Ischaemic stroke  1  1/4199 (0.02%)  1
Renal and urinary disorders   
Haematuria  1  10/4199 (0.24%)  10
Haemorrhage urinary tract  1  1/4199 (0.02%)  1
Nephrolithiasis  1  1/4199 (0.02%)  1
Reproductive system and breast disorders   
Haematospermia  1  1/4199 (0.02%)  1
Menorrhagia  1  1/4199 (0.02%)  1
Scrotal haematocoele  1  1/4199 (0.02%)  1
Respiratory, thoracic and mediastinal disorders   
Epistaxis  1  47/4199 (1.12%)  47
Dyspnoea  1  1/4199 (0.02%)  1
Haemoptysis  1  1/4199 (0.02%)  1
Skin and subcutaneous tissue disorders   
Rash  1  3/4199 (0.07%)  3
Skin haemorrhage  1  2/4199 (0.05%)  2
Dry skin  1  1/4199 (0.02%)  1
Ecchymosis  1  1/4199 (0.02%)  1
Rash erythematous  1  1/4199 (0.02%)  1
Rash generalise  1  1/4199 (0.02%)  1
Urticaria  1  1/4199 (0.02%)  1
Vascular disorders   
Haematoma  1  6/4199 (0.14%)  6
Haemorrhage  1  6/4199 (0.14%)  6
Arteriovenous fistula  1  1/4199 (0.02%)  1
Venous stenosis  1  1/4199 (0.02%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 12.1
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.
During the term of the agreement and for a period of one year thereafter, the PI must submit to Boston Scientific each paper, summary, abstract or outline that he intends to present or publish relating to the study, and will not submit or present any proposed publication to a publisher or other party prior to the expiration of 45 days from the date such Proposed Publication is submitted to Boston Scientific.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Peter Maurer, Director of Clinical Trials
Organization: Boston Scientific Corporation
Phone: 1-508-683-6678
EMail: Peter.Maurer@bsci.com
Publications of Results:
Lee DP, Paulus R, Giri K, Carr J, Baran KW, Hassel D, Winters KJ, Christen T, Dawkins KD, Garratt KN. TCT-167 Primary endpoint results of the TAXUS Libertē post-approval study. Journal of the American College of Cardiology. 2013;62:B54-B54
Garratt, KN, Lambert C, Kabour A, Stewart M, Hall P, Phillips WJ, Winters KJ, Christen T, Dawkins KD, Lee DP TCT-148 TAXUS Liberté PES With ASA + Prasugrel Is Associated With Low TVF, Bleeding And Adverse Event Rates Among Diabetic Patients With "On-Label" Stent Indications. Journal of the American College of Cardiology, 2013; 62 (18_S1): B47-B47.
Layout table for additonal information
Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT00997503    
Other Study ID Numbers: H7T-MC-TADN
S2035 ( Other Identifier: Boston Scientific )
First Submitted: October 15, 2009
First Posted: October 19, 2009
Results First Submitted: March 13, 2014
Results First Posted: April 13, 2015
Last Update Posted: August 7, 2015