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TAXUS Libertē Post Approval Study

This study has been completed.
Sponsor:
Collaborators:
Eli Lilly and Company
Daiichi Sankyo Inc.
Information provided by (Responsible Party):
Boston Scientific Corporation
ClinicalTrials.gov Identifier:
NCT00997503
First received: October 15, 2009
Last updated: July 20, 2015
Last verified: March 2015
Results First Received: March 13, 2014  
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

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
TAXUS Libertē: Overall Enrolled Population 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.

Participant Flow:   Overall Study
    TAXUS Libertē: Overall Enrolled Population
STARTED   4199 
12 Months   4059 [1] 
COMPLETED   3926 
NOT COMPLETED   273 
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)



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
TAXUS Liberté Post-Approval Study Enrolled Population 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.

Baseline Measures
   TAXUS Liberté Post-Approval Study Enrolled Population 
Overall Participants Analyzed 
[Units: Participants]
 4199 
Age 
[Units: Years]
Mean (Standard Deviation)
 59.8  (9.8) 
Gender 
[Units: Participants]
 
Female   1161 
Male   3038 
Race/Ethnicity, Customized [1] 
[Units: 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] Some participants may be allocated to greater than one category.
Region of Enrollment 
[Units: Participants]
 
United States   4199 
Weight 
[Units: Kilograms]
Mean (Standard Deviation)
 92.9  (20.7) 
Smoking Status 
[Units: Participants]
 
Current   1272 
Previous   1451 
Never   1387 
Unknown   89 
History of Hyperlipidemia Requiring Medication 
[Units: Participants]
 2950 
History of Hypertension Requiring Medication 
[Units: Participants]
 3130 
Diabetic (Medically Treated) 
[Units: Participants]
 1289 
Family History of Coronary Artery Disease (CAD) 
[Units: Participants]
 2466 
History of Atrial Fibrillation 
[Units: Participants]
 143 
History of Coronary Artery Bypass Graft (CABG) 
[Units: Participants]
 559 
History of Percutaneous Coronary Intervention (PCI) 
[Units: Participants]
 1411 
History of Congestive Heart Failure (CHF) 
[Units: Participants]
 254 
Current Stable Angina [1] 
[Units: Participants]
 1320 
[1] Canadian Cardiology Society Classification (CCSC)
Current Unstable Angina 
[Units: Participants]
 1385 
Current Silent Ischemia 
[Units: Participants]
 310 
Current Myocardial Infarction (MI) 
[Units: Participants]
 1040 
Experiencing Cardiogenic Shock [1] 
[Units: Participants]
 17 
[1] 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] 
[Units: Participants]
 1464 
[1] 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 
[Units: Participants]
 155 
History of Transient Ischemic Attack (TIA) 
[Units: Participants]
 4 
History of Stroke 
[Units: Participants]
 4 
Current Renal Dysfunction 
[Units: Participants]
 185 
History of Peripheral Vascular Disease 
[Units: Participants]
 284 
History of Major Bleeding 
[Units: Participants]
 32 
De Novo Lesion [1] 
[Units: Lesions]
 5421 
[1] A coronary lesion not previously treated.
Culprit Lesion for ST Elevation Myocardial Infarction (STEMI) 
[Units: Lesions]
 386 
Restenosis 
[Units: Lesions]
 
Restenosis - Drug Eluting Stent (DES)   168 
Restenosis - Bare Metal Stent (BMS)   82 
Restenotic Lesion (No Stent)   31 
Chronic Total Occlusion [1] 
[Units: Lesions]
 70 
[1] Lesion that has been totally occluded for three or more months and with a documented TIMI flow of 0.
Ostial Lesion [1] 
[Units: Lesions]
 216 
[1] Lesions involving the origin of the coronary artery within the first 3 mm.
Post Brachytherapy 
[Units: Lesions]
 5 
Bifurcated Lesion [1] 
[Units: Lesions]
 336 
[1] Lesion where a branch vessel of medium or large size originates.
Reference Vessel Diameter (RVD) 
[Units: Millimeters]
Mean (Standard Deviation)
 2.99  (0.5) 
Lesion Length [1] 
[Units: Millimeters]
Mean (Standard Deviation)
 16  (9.5) 
[1] 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] 
[Units: Lesions]
 
 501 
 197 
 679 
 4283 
[1]

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] 
[Units: Lesions]
 
Type A   1132 
Type B1   2298 
Type B2   1162 
Type C   1068 
[1] Please note the reference section for further definition of the lesion classification.
Lesion Calcification [1] 
[Units: Lesions]
 
None   3630 
Mild   1398 
Moderate   482 
Severe   150 
[1] 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) 
[Units: Percemt]
Mean (Standard Deviation)
 85.3  (11.7) 
Vessel Tortuosity 
[Units: Lesions]
 
None   3912 
Mild   1261 
Moderate   431 
Severe   56 
Lesion Location (Vessel) 
[Units: Lesions]
 
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) 
[Units: Lesions]
 
Yes   478 
Possibly   273 
No   4840 
Unknown   69 
Acute Coronary Syndrome (ACS) Present [1] 
[Units: Procedures]
 1194 
[1]
  • 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 
[Units: Procedures]
 3044 
Number of Lesions Treated Per Patient 
[Units: Lesions]
Mean (Standard Deviation)
 1.3  (0.7) 
Number of Vessels Treated Per Patient 
[Units: Vessels]
Mean (Standard Deviation)
 1.1  (0.4) 
Study Stents Implanted Per Patient 
[Units: Stents]
Mean (Standard Deviation)
 1.5  (0.8) 
Post-Procedure Thrombolysis In Myocardial Infarction (TIMI) Flow [1] 
[Units: Lesions]
 
 0 
 1 
 42 
 5617 
[1]

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) 
[Units: Percentage of diameter stenosis]
Mean (Standard Deviation)
 1.3  (4.2) 
Thrombus Present (Post-Procedure) 
[Units: Lesions]
 
Yes   27 
Possibly   45 
No   5588 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Cardiac Death or Myocardial Infarction   [ Time Frame: 12 months ]

2.  Secondary:   Incremental Rate of Stent Thrombosis (Protocol Definition)   [ Time Frame: 1-2 years ]

3.  Secondary:   Target Vessel Failure (TVF) for the Medically-Treated Diabetic Population   [ Time Frame: 12 months ]

4.  Secondary:   Rate of Major Adverse Cardiac and Cerebrovascular Events (MACCE)   [ Time Frame: 6 months ]

5.  Secondary:   Rate of Major Adverse Cardiac and Cerebrovascular Events (MACCE)   [ Time Frame: 12 months ]

6.  Secondary:   Rate of Major Adverse Cardiac & Cerebrovascular Events (MACCE): Study Stent Related   [ Time Frame: 6 months ]

7.  Secondary:   Rate of Major Adverse Cardiac and Cerebrovascular Events (MACCE): Study Stent Related   [ Time Frame: 12 months ]

8.  Secondary:   Rate of Major Adverse Cardiac Events (MACE)   [ Time Frame: 6 months ]

9.  Secondary:   Rate of Major Adverse Cardiac Events (MACE)   [ Time Frame: 12 months ]

10.  Secondary:   Rate of Major Adverse Cardiac Events (MACE): Study Stent Related   [ Time Frame: 6 months ]

11.  Secondary:   Rate of Major Adverse Cardiac Events (MACE): Study Stent Related   [ Time Frame: 12 months ]

12.  Secondary:   Rate of Target Vessel Failure (TVF)   [ Time Frame: 6 months ]

13.  Secondary:   Rate of Target Vessel Failure (TVF)   [ Time Frame: 12 months ]

14.  Secondary:   Rate of Cardiac Death or Myocardial Infarction (MI)   [ Time Frame: 6 months ]

15.  Secondary:   Rate of Cardiac Death or Myocardial Infarction (MI)   [ Time Frame: 12 months ]

16.  Secondary:   Rate of All Cause Death   [ Time Frame: 6 months ]

17.  Secondary:   Rate of All Cause Death   [ Time Frame: 12 months ]

18.  Secondary:   Rate of Cardiac Death   [ Time Frame: 6 months ]

19.  Secondary:   Rate of Cardiac Death   [ Time Frame: 12 months ]

20.  Secondary:   Rate of Cardiac Death: Study Stent Related   [ Time Frame: 6 months ]

21.  Secondary:   Rate of Cardiac Death: Study Stent Related   [ Time Frame: 12 months ]

22.  Secondary:   Rate of Myocardial Infarction (MI)   [ Time Frame: 6 months ]

23.  Secondary:   Rate of Myocardial Infarction (MI)   [ Time Frame: 12 months ]

24.  Secondary:   Rate of Myocardial Infarction (MI): Study Stent Related   [ Time Frame: 6 months ]

25.  Secondary:   Rate of Myocardial Infarction (MI): Study Stent Related   [ Time Frame: 12 months ]

26.  Secondary:   Rate of Target Vessel Reintervention (TVR)   [ Time Frame: 6 months ]

27.  Secondary:   Rate of Target Vessel Reintervention (TVR)   [ Time Frame: 12 months ]

28.  Secondary:   Rate of Target Vessel Reintervention (TVR): Study Stent Related   [ Time Frame: 6 months ]

29.  Secondary:   Rate of Target Vessel Reintervention (TVR): Study Stent Related   [ Time Frame: 12 months ]

30.  Secondary:   Rate of Stroke   [ Time Frame: 6 months ]

31.  Secondary:   Rate of Stroke   [ Time Frame: 12 months ]

32.  Secondary:   Rate of Major Bleeding   [ Time Frame: 6 months ]

33.  Secondary:   Rate of Major Bleeding   [ Time Frame: 12 months ]

34.  Secondary:   Rate of Stent Thrombosis (ARC Definite + Probable)   [ Time Frame: 6 months ]

35.  Secondary:   Rate of Stent Thrombosis (ARC Definite + Probable)   [ Time Frame: 12 months ]

36.  Secondary:   Rate of Stent Thrombosis (Protocol Definition)   [ Time Frame: 6 months ]

37.  Secondary:   Rate of Stent Thrombosis (Protocol Definition)   [ Time Frame: 12 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Peter Maurer, Director of Clinical Trials
Organization: Boston Scientific Corporation
phone: 1-508-683-6678
e-mail: 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.

Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT00997503     History of Changes
Other Study ID Numbers: H7T-MC-TADN
S2035 ( Other Identifier: Boston Scientific )
Study First Received: October 15, 2009
Results First Received: March 13, 2014
Last Updated: July 20, 2015
Health Authority: United States: Institutional Review Board