TAXUS Libertē Post Approval Study

This study is ongoing, but not recruiting participants.
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: March 25, 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
No text entered.

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.
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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  
Number of Participants  
[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  
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 [2]
[units: participants]
  1320  
Current Unstable Angina  
[units: participants]
  1385  
Current Silent Ischemia  
[units: participants]
  310  
Current Myocardial Infarction (MI)  
[units: participants]
  1040  
Experiencing Cardiogenic Shock [3]
[units: participants]
  17  
History of Multivessel Disease [4]
[units: participants]
  1464  
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 [5]
[units: lesions]
  5421  
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 [6]
[units: lesions]
  70  
Ostial Lesion [7]
[units: lesions]
  216  
Post Brachytherapy  
[units: lesions]
  5  
Bifurcated Lesion [8]
[units: lesions]
  336  
Reference Vessel Diameter (RVD)  
[units: millimeters]
Mean (Standard Deviation)
  2.99  (0.5)  
Lesion Length [9]
[units: millimeters]
Mean (Standard Deviation)
  16  (9.5)  
Pre-Procedure Thrombolysis In Myocardial Infarction (TIMI) Flow [10]
[units: lesions]
 
0     501  
1     197  
2     679  
3     4283  
Lesion Classification: American College of Cardiology (ACC)/ American Heart Association (AHA) [11]
[units: lesions]
 
Type A     1132  
Type B1     2298  
Type B2     1162  
Type C     1068  
Lesion Calcification [12]
[units: lesions]
 
None     3630  
Mild     1398  
Moderate     482  
Severe     150  
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 [13]
[units: procedures]
  1194  
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 [10]
[units: lesions]
 
0     0  
1     1  
2     42  
3     5617  
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  
[1] Some participants may be allocated to greater than one category.
[2] Canadian Cardiology Society Classification (CCSC)
[3] 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.
[4] The presence of a greater than 50% diameter stenosis in 2 or 3 major epicardial coronary vessels or bypassed branches.
[5] A coronary lesion not previously treated.
[6] Lesion that has been totally occluded for three or more months and with a documented TIMI flow of 0.
[7] Lesions involving the origin of the coronary artery within the first 3 mm.
[8] Lesion where a branch vessel of medium or large size originates.
[9] 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).
[10]

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.

[11] Please note the reference section for further definition of the lesion classification.
[12] 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.
[13]
  • 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.



  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:

Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT00997503     History of Changes
Other Study ID Numbers: H7T-MC-TADN, S2035
Study First Received: October 15, 2009
Results First Received: March 13, 2014
Last Updated: March 25, 2015
Health Authority: United States: Institutional Review Board