TAXUS Libertē Post Approval Study

Study Overview
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Brief Summary
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The TAXUS Libertē Post-Approval Study is an FDA-mandated prospective, multi-center study designed to collect real-world safety and clinical outcomes in approximately 4,200 patients receiving one or more TAXUS Liberté Paclitaxel-Eluting Stents and prasugrel as part of a dual antiplatelet therapy (DAPT) drug regimen. This study will also contribute patient data to an FDA-requested and industry-sponsored research study that will evaluate the optimal duration of dual antiplatelet therapy (DAPT Study).

Detailed Description
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The TAXUS Libertē Post-Approval Study is an FDA-mandated prospective, multi-center study designed to collect real-world safety and clinical outcomes in approximately 4,200 patients receiving one or more TAXUS Liberté Paclitaxel-Eluting Stents and prasugrel as part of a dual antiplatelet therapy (DAPT) drug regimen. This is a consecutively-enrolled study with patient follow-up through 3 years post index procedure. This study also will contribute patient data to an FDA-requested and industry-sponsored research study that will evaluate the optimal duration of dual antiplatelet therapy (DAPT Study). To facilitate this patient data contribution, patients will be assigned to patient groups based upon their co-morbidities and stented lesions identified post index procedure. All enrolled patients who have been treated with the TAXUS Liberté Stent will be assigned to 12 months of open-label prasugrel treatment and aspirin. Upon completion of the open-label period, patients who are clear of events at 12 months post index procedure will be randomized 1:1 to either a placebo or prasugrel for an additional 18 months of treatment. All patients will receive aspirin therapy throughout the course of the study.

Official Title
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TAXUS Libertē Post Approval Study: A U.S. Post-Approval Study of the TAXUS® Liberté® Paclitaxel-Eluting Coronary Stent System

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Device: TAXUS Liberté Paclitaxel-Eluting Coronary Stent
* Drug: prasugrel
* Drug: placebo
* Drug: aspirin


Participation Criteria
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Eligibility Criteria
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Enrollment Inclusion Criteria Patient is > 18 years of age. Consecutive patients who have signed an Informed Consent Form, who do not otherwise meet applicable exclusion criteria, and who are eligible to receive a TAXUS Liberté Stent and the study required DAPT will be evaluated for enrollment in this study. Enrollment Exclusion Criteria Patient with known hypersensitivity to paclitaxel or structurally related compounds. Patient with known hypersensitivity to the polymer or any of its individual components. Patient judged to have a lesion that prevents complete inflation of an angioplasty balloon or proper placement of the stent or delivery device. Patient who cannot receive the protocol required dual antiplatelet therapy. Patient on warfarin or similar anticoagulant therapy. Patient with known pregnancy. Planned surgery necessitating discontinuation of antiplatelet therapy(> 14 days)within the 30-months following enrollment. Current medical condition with a life expectancy of less than 3 years. Patient currently enrolled in another device or drug study whose protocol specifically excludes concurrent enrollment or that involves blinded placement of a drug-eluting stent other than the TAXUS Liberté Stent. Patient judged unable to cooperate with prolonged DAPT. Patient unable to give informed consent. Patient judged inappropriate for randomization due to other condition requiring chronic thienopyridine use. Patient treated with both a drug-eluting stent and a bare-metal stent during the index procedure. Patient who experienced a prior transient ischemic attack (TIA) or a prior stroke. Patient requiring chronic daily use (greater than 2 consecutive weeks) of non-steroidal anti-inflammatory drugs (NSAIDs) with the exception of aspirin. Occasional use of NSAIDs on an as needed or prn schedule is not exclusionary. Patient with active pathological bleeding (such as peptic ulcer or intracranial hemorrhage). Additional Exclusion Criteria (applicable only after patient enrollment has reached approximately 3600) Patient who experienced a myocardial infarction (MI) within 72 hours prior to the index procedure. Patient with a history of (includes current) left main coronary artery disease. Patient who requires stenting of > 1 vessel with a TAXUS Liberté stent during the index procedure. Patient who requires stenting of > 2 vessels during the index procedure. Patient who requires a staged procedure within 6-weeks following the index procedure, in whom > 1 vessel was stented during the index procedure. Patient with cardiogenic shock. Patient with acute or chronic renal dysfunction (serum creatinine >3.0 mg/dl or patient receiving dialysis). Target Lesion that meets any of the following criteria: Located within a saphenous vein graft or an arterial graft Chronic total occlusion Restenosis from a previously implanted drug-eluting or bare-metal stent Previous use of intravascular brachytherapy in target vessel Lesion involves a bifurcation Lesion is ostial in location Severe tortuosity in the target lesion or target vessel proximal to the target lesion Moderate or severe calcification by visual estimate in the target lesion or target vessel proximal to the target lesion RVD < 2.5 mm or RVD > 3.75 mm Lesion length > 28 mm Randomization Inclusion Criteria (12-months): Patient is 12-Month Clear, which is defined as patients enrolled in the study who are free from all death, MI, stroke, repeat coronary revascularization, stent thrombosis and major bleeding (severe or moderate by GUSTO classification) 12 months after stent implantation and who are compliant with 12 months of DAPT following stent implantation. Exceptions to this rule are: Patients who experience repeat PCI, stent thrombosis and/or myocardial infarction occurring within 6 weeks after the index procedure will not be excluded from the definition of 12-Month Clear. Patient was compliant with DAPT during the first 12 months of the study. Compliance is defined as the patient taking between 80% and 120% of prasugrel in the 0-6 month and 6-12 month periods without an interruption of therapy longer than 14 days. Compliance at both time points is required to be considered 12-Month Clear. Randomization Exclusion Criteria (12-months): Known pregnancy. Patient switched from prasugrel to other thienopyridine after discharge from index hospitalization. Patient switched maintenance dose of prasugrel (such as 10mg to 5mg; or 5mg to 10mg) within 6-months prior to randomization. Percutaneous coronary intervention or cardiac surgery between 6 weeks post index procedure and randomization. Planned surgery necessitating discontinuation of antiplatelet therapy (> 14 days) within the 21 months following randomization. Patients on warfarin or similar anticoagulant therapy. Current medical condition with life expectancy of less than 3 years.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: TAXUS Liberté Paclitaxel-Eluting Coronary Stent|The TAXUS Liberté Paclitaxel-Eluting Coronary Stent System is a device/drug combination product comprised of two regulated components: a device (Liberté Coronary Stent System) and a drug product (a formulation of paclitaxel contained in a polymer coating).The polymer coating serves as a carrier system to provide uniform and controlled biphasic release of the drug into the vessel wall once the stent is deployed.|
|Drug: prasugrel|10mg or 5mg, oral, once daily as maintenance dose through 30-months following index procedure|
|Drug: placebo|Oral placebo to match both 10mg and 5mg prasugrel tablets.|
|Drug: aspirin|Oral, as prescribed by physician through end of study. .|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiac Death or Myocardial Infarction | 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. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incremental Rate of Stent Thrombosis (Protocol Definition) | Stent Thrombosis (protocol definition): The occurrence of any of the following: 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 Acute MI in the distribution of the treated vessel. 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. | 1-2 years | 
| Target Vessel Failure (TVF) for the Medically-Treated Diabetic Population | 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 | 12 months | 
| Rate of Major Adverse Cardiac and Cerebrovascular Events (MACCE) | MACCE defined as the composite of cardiac death, myocardial infarction, target vessel revascularization and stroke. Binary rate | 6 months | 
| Rate of Major Adverse Cardiac and Cerebrovascular Events (MACCE) | MACCE defined as the composite of cardiac death, myocardial infarction, target vessel revascularization and stroke. Binary rate | 12 months | 
| Rate of Major Adverse Cardiac & Cerebrovascular Events (MACCE): Study Stent Related | MACCE defined as the composite of cardiac death, myocardial infarction, target vessel revascularization and stroke. | 6 months | 
| Rate of Major Adverse Cardiac and Cerebrovascular Events (MACCE): Study Stent Related | MACCE defined as the composite of cardiac death, myocardial infarction, target vessel revascularization and stroke. Binary rate | 12 months | 
| Rate of Major Adverse Cardiac Events (MACE) | MACE defined as the composite of cardiac death, myocardial infarction and target vessel revascularization. Binary rate | 6 months | 
| Rate of Major Adverse Cardiac Events (MACE) | MACE defined as the composite of cardiac death, myocardial infarction and target vessel revascularization. Binary rate | 12 months | 
| Rate of Major Adverse Cardiac Events (MACE): Study Stent Related | MACE defined as the composite of cardiac death, myocardial infarction and target vessel revascularization. Binary rate | 6 months | 
| Rate of Major Adverse Cardiac Events (MACE): Study Stent Related | MACE defined as the composite of cardiac death, myocardial infarction and target vessel revascularization. Binary rate | 12 months | 
| Rate of Target Vessel Failure (TVF) | 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 | 6 months | 
| Rate of Target Vessel Failure (TVF) | 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 | 12 months | 
| Rate of Cardiac Death or Myocardial Infarction (MI) | - Binary Rate | 6 months | 
| Rate of Cardiac Death or Myocardial Infarction (MI) | - Binary Rate | 12 months | 
| Rate of All Cause Death | -Binary rate | 6 months | 
| Rate of All Cause Death | -Binary rate | 12 months | 
| Rate of Cardiac Death | -Binary rate | 6 months | 
| Rate of Cardiac Death | -Binary rate | 12 months | 
| Rate of Cardiac Death: Study Stent Related | -Binary rate | 6 months | 
| Rate of Cardiac Death: Study Stent Related | -Binary rate | 12 months | 
| Rate of Myocardial Infarction (MI) | -Binary rate | 6 months | 
| Rate of Myocardial Infarction (MI) | -Binary rate | 12 months | 
| Rate of Myocardial Infarction (MI): Study Stent Related | -Binary rate | 6 months | 
| Rate of Myocardial Infarction (MI): Study Stent Related | -Binary rate | 12 months | 
| Rate of Target Vessel Reintervention (TVR) | -Binary rate | 6 months | 
| Rate of Target Vessel Reintervention (TVR) | -Binary rate | 12 months | 
| Rate of Target Vessel Reintervention (TVR): Study Stent Related | -Binary rate | 6 months | 
| Rate of Target Vessel Reintervention (TVR): Study Stent Related | -Binary rate | 12 months | 
| Rate of Stroke | -Binary Rate | 6 months | 
| Rate of Stroke | -Binary Rate | 12 months | 
| Rate of Major Bleeding | Major Bleeding defined as the composite of severe or moderate bleeding complication (based upon GUSTO classification). Binary rate | 6 months | 
| Rate of Major Bleeding | Major Bleeding defined as the composite of severe or moderate bleeding complication (based upon GUSTO classification). Binary rate | 12 months | 
| Rate of Stent Thrombosis (ARC Definite + Probable) | ARC - Academic Research Consortium Binary rate | 6 months | 
| Rate of Stent Thrombosis (ARC Definite + Probable) | ARC - Academic Research Consortium Binary Rate | 12 months | 
| Rate of Stent Thrombosis (Protocol Definition) | -Binary rate The occurrence of any of the following: 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 Acute MI in the distribution of the treated vessel. 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. | 6 months | 
| Rate of Stent Thrombosis (Protocol Definition) | -Binary rate The occurrence of any of the following: 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 Acute MI in the distribution of the treated vessel. 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. | 12 months |