Coronary Artery Disease
Conditions
Brief summary
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
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.
Interventions
DEVICETAXUS 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.
DRUGprasugrel
10mg or 5mg, oral, once daily as maintenance dose through 30-months following index procedure
DRUGplacebo
Oral placebo to match both 10mg and 5mg prasugrel tablets.
DRUGaspirin
Oral, as prescribed by physician through end of study. .
Sponsors
Eli Lilly and Company
Daiichi Sankyo
Boston Scientific Corporation
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cardiac Death or Myocardial Infarction | 12 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Target Vessel Failure (TVF) for the Medically-Treated Diabetic Population | 12 months | 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 |
| Rate of Major Adverse Cardiac and Cerebrovascular Events (MACCE) | 6 months | * MACCE defined as the composite of cardiac death, myocardial infarction, target vessel revascularization and stroke. * Binary rate |
| Rate of Major Adverse Cardiac & Cerebrovascular Events (MACCE): Study Stent Related | 6 months | MACCE defined as the composite of cardiac death, myocardial infarction, target vessel revascularization and stroke. |
| Rate of Major Adverse Cardiac and Cerebrovascular Events (MACCE): Study Stent Related | 12 months | * MACCE defined as the composite of cardiac death, myocardial infarction, target vessel revascularization and stroke. * Binary rate |
| Rate of Major Adverse Cardiac Events (MACE) | 6 months | * MACE defined as the composite of cardiac death, myocardial infarction and target vessel revascularization. * Binary rate |
| Rate of Major Adverse Cardiac Events (MACE): Study Stent Related | 6 months | * MACE defined as the composite of cardiac death, myocardial infarction and target vessel revascularization. * Binary rate |
| Rate of Target Vessel Failure (TVF) | 6 months | * 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 |
| Rate of Cardiac Death or Myocardial Infarction (MI) | 6 months | \- Binary Rate |
| Rate of All Cause Death | 6 months | -Binary rate |
| Incremental Rate of Stent Thrombosis (Protocol Definition) | 1-2 years | 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. |
| Rate of Cardiac Death: Study Stent Related | 6 months | -Binary rate |
| Rate of Myocardial Infarction (MI) | 6 months | -Binary rate |
| Rate of Myocardial Infarction (MI): Study Stent Related | 6 months | -Binary rate |
| Rate of Target Vessel Reintervention (TVR) | 6 months | -Binary rate |
| Rate of Target Vessel Reintervention (TVR): Study Stent Related | 6 months | -Binary rate |
| Rate of Stroke | 6 months | -Binary Rate |
| Rate of Major Bleeding | 6 months | * Major Bleeding defined as the composite of severe or moderate bleeding complication (based upon GUSTO classification). * Binary rate |
| Rate of Stent Thrombosis (ARC Definite + Probable) | 6 months | * ARC - Academic Research Consortium * Binary rate |
| Rate of Stent Thrombosis (Protocol Definition) | 6 months | -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. |
| Rate of Cardiac Death | 6 months | -Binary rate |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 4,199 |
| Total | 4,199 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 3 |
| Overall Study | Death | 53 |
| Overall Study | Lost to Follow-up | 33 |
| Overall Study | Missed 12-month follow-up | 85 |
| Overall Study | Other reason | 13 |
| Overall Study | Physician Decision | 10 |
| Overall Study | Withdrawal by Subject | 76 |
Baseline characteristics
| Characteristic | TAXUS Liberté Post-Approval Study Enrolled Population |
|---|---|
| Acute Coronary Syndrome (ACS) Present | 1194 procedures |
| Age, Continuous | 59.8 years STANDARD_DEVIATION 9.8 |
| Bifurcated Lesion | 336 lesions |
| Chronic Total Occlusion | 70 lesions |
| Culprit Lesion for ST Elevation Myocardial Infarction (STEMI) | 386 lesions |
| Current Myocardial Infarction (MI) | 1040 participants |
| Current Renal Dysfunction | 185 participants |
| Current Silent Ischemia | 310 participants |
| Current Stable Angina | 1320 participants |
| Current Unstable Angina | 1385 participants |
| De Novo Lesion | 5421 lesions |
| Diabetic (Medically Treated) | 1289 participants |
| Experiencing Cardiogenic Shock | 17 participants |
| Family History of Coronary Artery Disease (CAD) | 2466 participants |
| History of Atrial Fibrillation | 143 participants |
| History of Congestive Heart Failure (CHF) | 254 participants |
| History of Coronary Artery Bypass Graft (CABG) | 559 participants |
| History of Hyperlipidemia Requiring Medication | 2950 participants |
| History of Hypertension Requiring Medication | 3130 participants |
| History of Left Main Disease | 155 participants |
| History of Major Bleeding | 32 participants |
| History of Multivessel Disease | 1464 participants |
| History of Percutaneous Coronary Intervention (PCI) | 1411 participants |
| History of Peripheral Vascular Disease | 284 participants |
| History of Stroke | 4 participants |
| History of Transient Ischemic Attack (TIA) | 4 participants |
| Lesion Calcification Mild | 1398 lesions |
| Lesion Calcification Moderate | 482 lesions |
| Lesion Calcification None | 3630 lesions |
| Lesion Calcification Severe | 150 lesions |
| Lesion Classification: American College of Cardiology (ACC)/ American Heart Association (AHA) Type A | 1132 lesions |
| Lesion Classification: American College of Cardiology (ACC)/ American Heart Association (AHA) Type B1 | 2298 lesions |
| Lesion Classification: American College of Cardiology (ACC)/ American Heart Association (AHA) Type B2 | 1162 lesions |
| Lesion Classification: American College of Cardiology (ACC)/ American Heart Association (AHA) Type C | 1068 lesions |
| Lesion Length | 16 millimeters STANDARD_DEVIATION 9.5 |
| Lesion Location (Vessel) Arterial or Vein Graft | 167 lesions |
| Lesion Location (Vessel) Left Anterior Descending (LAD) Coronary Artery | 2198 lesions |
| Lesion Location (Vessel) Left Circumflex (LCX) Coronary Artery | 1306 lesions |
| Lesion Location (Vessel) Left Main (LM) Coronary Artery | 46 lesions |
| Lesion Location (Vessel) Right Coronary Artery (RCA) | 1943 lesions |
| Number of Lesions Treated Per Patient | 1.3 lesions STANDARD_DEVIATION 0.7 |
| Number of Vessels Treated Per Patient | 1.1 vessels STANDARD_DEVIATION 0.4 |
| Ostial Lesion | 216 lesions |
| Post Brachytherapy | 5 lesions |
| Post-Procedure Target Lesion Percent Diameter Stenosis (%DS) | 1.3 percentage of diameter stenosis STANDARD_DEVIATION 4.2 |
| Post-Procedure Thrombolysis In Myocardial Infarction (TIMI) Flow 0 | 0 lesions |
| Post-Procedure Thrombolysis In Myocardial Infarction (TIMI) Flow 1 | 1 lesions |
| Post-Procedure Thrombolysis In Myocardial Infarction (TIMI) Flow 2 | 42 lesions |
| Post-Procedure Thrombolysis In Myocardial Infarction (TIMI) Flow 3 | 5617 lesions |
| Pre-dilatation Performed | 3044 procedures |
| Pre-Procedure Target Lesion Percent Diameter Stenosis (%DS) | 85.3 percemt STANDARD_DEVIATION 11.7 |
| Pre-Procedure Thrombolysis In Myocardial Infarction (TIMI) Flow 0 | 501 lesions |
| Pre-Procedure Thrombolysis In Myocardial Infarction (TIMI) Flow 1 | 197 lesions |
| Pre-Procedure Thrombolysis In Myocardial Infarction (TIMI) Flow 2 | 679 lesions |
| Pre-Procedure Thrombolysis In Myocardial Infarction (TIMI) Flow 3 | 4283 lesions |
| Race/Ethnicity, Customized American Indian or Alaska Native | 16 participants |
| Race/Ethnicity, Customized Asian | 23 participants |
| Race/Ethnicity, Customized Black, or African Heritage | 323 participants |
| Race/Ethnicity, Customized Caucasian | 3623 participants |
| Race/Ethnicity, Customized Hispanic or Latino | 181 participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 8 participants |
| Race/Ethnicity, Customized Other | 43 participants |
| Reference Vessel Diameter (RVD) | 2.99 millimeters STANDARD_DEVIATION 0.5 |
| Region of Enrollment United States | 4199 participants |
| Restenosis Restenosis - Bare Metal Stent (BMS) | 82 lesions |
| Restenosis Restenosis - Drug Eluting Stent (DES) | 168 lesions |
| Restenosis Restenotic Lesion (No Stent) | 31 lesions |
| Sex: Female, Male Female | 1161 Participants |
| Sex: Female, Male Male | 3038 Participants |
| Smoking Status Current | 1272 participants |
| Smoking Status Never | 1387 participants |
| Smoking Status Previous | 1451 participants |
| Smoking Status Unknown | 89 participants |
| Study Stents Implanted Per Patient | 1.5 stents STANDARD_DEVIATION 0.8 |
| Thrombus Present (Post-Procedure) No | 5588 lesions |
| Thrombus Present (Post-Procedure) Possibly | 45 lesions |
| Thrombus Present (Post-Procedure) Yes | 27 lesions |
| Thrombus Present (Pre-Procedure) No | 4840 lesions |
| Thrombus Present (Pre-Procedure) Possibly | 273 lesions |
| Thrombus Present (Pre-Procedure) Unknown | 69 lesions |
| Thrombus Present (Pre-Procedure) Yes | 478 lesions |
| Vessel Tortuosity Mild | 1261 lesions |
| Vessel Tortuosity Moderate | 431 lesions |
| Vessel Tortuosity None | 3912 lesions |
| Vessel Tortuosity Severe | 56 lesions |
| Weight | 92.9 kilograms STANDARD_DEVIATION 20.7 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 293 / 4,199 |
| serious Total, serious adverse events | 1,232 / 4,199 |
Outcome results
Primary
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.
Time frame: 12 months
Population: 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 | Measure | Value (NUMBER) |
|---|---|---|
| TAXUS Libertē Post-Approval Study Enrolled Population | Cardiac Death or Myocardial Infarction | 2.1 percentage of participants |
Secondary
Incremental Rate of Stent Thrombosis (Protocol Definition)
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
Population: 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 | Measure | Value (NUMBER) |
|---|---|---|
| TAXUS Libertē Post-Approval Study Enrolled Population | Incremental Rate of Stent Thrombosis (Protocol Definition) | 1.3 percentage of participants |
Secondary
Rate of All Cause Death
-Binary rate
Time frame: 6 months
Population: 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 | Measure | Value (NUMBER) |
|---|---|---|
| TAXUS Libertē Post-Approval Study Enrolled Population | Rate of All Cause Death | 0.7 percentage of participants |
Secondary
Rate of All Cause Death
-Binary rate
Time frame: 12 months
Population: 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 | Measure | Value (NUMBER) |
|---|---|---|
| TAXUS Libertē Post-Approval Study Enrolled Population | Rate of All Cause Death | 1.4 percentage of participants |
Secondary
Rate of Cardiac Death
-Binary rate
Time frame: 6 months
Population: 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 | Measure | Value (NUMBER) |
|---|---|---|
| TAXUS Libertē Post-Approval Study Enrolled Population | Rate of Cardiac Death | 0.4 percentage of participants |
Secondary
Rate of Cardiac Death
-Binary rate
Time frame: 12 months
Population: 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 | Measure | Value (NUMBER) |
|---|---|---|
| TAXUS Libertē Post-Approval Study Enrolled Population | Rate of Cardiac Death | 0.9 percentage of participants |
Secondary
Rate of Cardiac Death or Myocardial Infarction (MI)
\- Binary Rate
Time frame: 6 months
Population: 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 | Measure | Value (NUMBER) |
|---|---|---|
| TAXUS Libertē Post-Approval Study Enrolled Population | Rate of Cardiac Death or Myocardial Infarction (MI) | 1.4 percentage of participants |
Secondary
Rate of Cardiac Death or Myocardial Infarction (MI)
\- Binary Rate
Time frame: 12 months
Population: 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 | Measure | Value (NUMBER) |
|---|---|---|
| TAXUS Libertē Post-Approval Study Enrolled Population | Rate of Cardiac Death or Myocardial Infarction (MI) | 2.1 percentage of participants |
Secondary
Rate of Cardiac Death: Study Stent Related
-Binary rate
Time frame: 12 months
Population: 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 | Measure | Value (NUMBER) |
|---|---|---|
| TAXUS Libertē Post-Approval Study Enrolled Population | Rate of Cardiac Death: Study Stent Related | 0.1 percentage of participants |
Secondary
Rate of Cardiac Death: Study Stent Related
-Binary rate
Time frame: 6 months
Population: 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 | Measure | Value (NUMBER) |
|---|---|---|
| TAXUS Libertē Post-Approval Study Enrolled Population | Rate of Cardiac Death: Study Stent Related | 0.1 percentage of participants |
Secondary
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
Time frame: 6 months
Population: 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 | Measure | Value (NUMBER) |
|---|---|---|
| TAXUS Libertē Post-Approval Study Enrolled Population | Rate of Major Adverse Cardiac and Cerebrovascular Events (MACCE) | 4.7 percentage of participants |
Secondary
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
Time frame: 12 months
Population: 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 | Measure | Value (NUMBER) |
|---|---|---|
| TAXUS Libertē Post-Approval Study Enrolled Population | Rate of Major Adverse Cardiac and Cerebrovascular Events (MACCE) | 7.8 percentage of participants |
Secondary
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
Time frame: 12 months
Population: 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 | Measure | Value (NUMBER) |
|---|---|---|
| TAXUS Libertē Post-Approval Study Enrolled Population | Rate of Major Adverse Cardiac and Cerebrovascular Events (MACCE): Study Stent Related | 4.9 percentage of participants |
Secondary
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.
Time frame: 6 months
Population: 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 | Measure | Value (NUMBER) |
|---|---|---|
| TAXUS Libertē Post-Approval Study Enrolled Population | Rate of Major Adverse Cardiac & Cerebrovascular Events (MACCE): Study Stent Related | 3.1 percentage of participants |
Secondary
Rate of Major Adverse Cardiac Events (MACE)
* MACE defined as the composite of cardiac death, myocardial infarction and target vessel revascularization. * Binary rate
Time frame: 12 months
Population: 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 | Measure | Value (NUMBER) |
|---|---|---|
| TAXUS Libertē Post-Approval Study Enrolled Population | Rate of Major Adverse Cardiac Events (MACE) | 7.3 percentage of participants |
Secondary
Rate of Major Adverse Cardiac Events (MACE)
* MACE defined as the composite of cardiac death, myocardial infarction and target vessel revascularization. * Binary rate
Time frame: 6 months
Population: 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 | Measure | Value (NUMBER) |
|---|---|---|
| TAXUS Libertē Post-Approval Study Enrolled Population | Rate of Major Adverse Cardiac Events (MACE) | 4.3 percentage of participants |
Secondary
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
Time frame: 6 months
Population: 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 | Measure | Value (NUMBER) |
|---|---|---|
| TAXUS Libertē Post-Approval Study Enrolled Population | Rate of Major Adverse Cardiac Events (MACE): Study Stent Related | 3.1 percentage of participants |
Secondary
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
Time frame: 12 months
Population: 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 | Measure | Value (NUMBER) |
|---|---|---|
| TAXUS Libertē Post-Approval Study Enrolled Population | Rate of Major Adverse Cardiac Events (MACE): Study Stent Related | 4.9 percentage of participants |
Secondary
Rate of Major Bleeding
* Major Bleeding defined as the composite of severe or moderate bleeding complication (based upon GUSTO classification). * Binary rate
Time frame: 6 months
Population: 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 | Measure | Value (NUMBER) |
|---|---|---|
| TAXUS Libertē Post-Approval Study Enrolled Population | Rate of Major Bleeding | 2.3 percentage of participants |
Secondary
Rate of Major Bleeding
* Major Bleeding defined as the composite of severe or moderate bleeding complication (based upon GUSTO classification). * Binary rate
Time frame: 12 months
Population: 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 | Measure | Value (NUMBER) |
|---|---|---|
| TAXUS Libertē Post-Approval Study Enrolled Population | Rate of Major Bleeding | 3.6 percentage of participants |
Secondary
Rate of Myocardial Infarction (MI)
-Binary rate
Time frame: 12 months
Population: 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 | Measure | Value (NUMBER) |
|---|---|---|
| TAXUS Libertē Post-Approval Study Enrolled Population | Rate of Myocardial Infarction (MI) | 1.4 percentage of participants |
Secondary
Rate of Myocardial Infarction (MI)
-Binary rate
Time frame: 6 months
Population: 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 | Measure | Value (NUMBER) |
|---|---|---|
| TAXUS Libertē Post-Approval Study Enrolled Population | Rate of Myocardial Infarction (MI) | 1.0 percentage of participants |
Secondary
Rate of Myocardial Infarction (MI): Study Stent Related
-Binary rate
Time frame: 12 months
Population: 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 | Measure | Value (NUMBER) |
|---|---|---|
| TAXUS Libertē Post-Approval Study Enrolled Population | Rate of Myocardial Infarction (MI): Study Stent Related | 1.0 percentage of participants |
Secondary
Rate of Myocardial Infarction (MI): Study Stent Related
-Binary rate
Time frame: 6 months
Population: 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 | Measure | Value (NUMBER) |
|---|---|---|
| TAXUS Libertē Post-Approval Study Enrolled Population | Rate of Myocardial Infarction (MI): Study Stent Related | 0.9 percentage of participants |
Secondary
Rate of Stent Thrombosis (ARC Definite + Probable)
* ARC - Academic Research Consortium * Binary rate
Time frame: 6 months
Population: 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 | Measure | Value (NUMBER) |
|---|---|---|
| TAXUS Libertē Post-Approval Study Enrolled Population | Rate of Stent Thrombosis (ARC Definite + Probable) | 0.6 percentage of participants |
Secondary
Rate of Stent Thrombosis (ARC Definite + Probable)
* ARC - Academic Research Consortium * Binary Rate
Time frame: 12 months
Population: 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 | Measure | Value (NUMBER) |
|---|---|---|
| TAXUS Libertē Post-Approval Study Enrolled Population | Rate of Stent Thrombosis (ARC Definite + Probable) | 0.8 percentage of participants |
Secondary
Rate of Stent Thrombosis (Protocol Definition)
-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
Population: 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 | Measure | Value (NUMBER) |
|---|---|---|
| TAXUS Libertē Post-Approval Study Enrolled Population | Rate of Stent Thrombosis (Protocol Definition) | 0.9 percentage of participants |
Secondary
Rate of Stent Thrombosis (Protocol Definition)
-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
Population: 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 | Measure | Value (NUMBER) |
|---|---|---|
| TAXUS Libertē Post-Approval Study Enrolled Population | Rate of Stent Thrombosis (Protocol Definition) | 0.6 percentage of participants |
Secondary
Rate of Stroke
-Binary Rate
Time frame: 6 months
Population: 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 | Measure | Value (NUMBER) |
|---|---|---|
| TAXUS Libertē Post-Approval Study Enrolled Population | Rate of Stroke | 0.4 percentage of participants |
Secondary
Rate of Stroke
-Binary Rate
Time frame: 12 months
Population: 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 | Measure | Value (NUMBER) |
|---|---|---|
| TAXUS Libertē Post-Approval Study Enrolled Population | Rate of Stroke | 0.5 percentage of participants |
Secondary
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
Time frame: 6 months
Population: 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 | Measure | Value (NUMBER) |
|---|---|---|
| TAXUS Libertē Post-Approval Study Enrolled Population | Rate of Target Vessel Failure (TVF) | 3.9 percentage of participants |
Secondary
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
Time frame: 12 months
Population: 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 | Measure | Value (NUMBER) |
|---|---|---|
| TAXUS Libertē Post-Approval Study Enrolled Population | Rate of Target Vessel Failure (TVF) | 6.4 percentage of participants |
Secondary
Rate of Target Vessel Reintervention (TVR)
-Binary rate
Time frame: 12 months
Population: 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 | Measure | Value (NUMBER) |
|---|---|---|
| TAXUS Libertē Post-Approval Study Enrolled Population | Rate of Target Vessel Reintervention (TVR) | 5.8 percentage of participants |
Secondary
Rate of Target Vessel Reintervention (TVR)
-Binary rate
Time frame: 6 months
Population: 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 | Measure | Value (NUMBER) |
|---|---|---|
| TAXUS Libertē Post-Approval Study Enrolled Population | Rate of Target Vessel Reintervention (TVR) | 3.3 percentage of participants |
Secondary
Rate of Target Vessel Reintervention (TVR): Study Stent Related
-Binary rate
Time frame: 6 months
Population: 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 | Measure | Value (NUMBER) |
|---|---|---|
| TAXUS Libertē Post-Approval Study Enrolled Population | Rate of Target Vessel Reintervention (TVR): Study Stent Related | 2.5 percentage of participants |
Secondary
Rate of Target Vessel Reintervention (TVR): Study Stent Related
-Binary rate
Time frame: 12 months
Population: 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 | Measure | Value (NUMBER) |
|---|---|---|
| TAXUS Libertē Post-Approval Study Enrolled Population | Rate of Target Vessel Reintervention (TVR): Study Stent Related | 4.3 percentage of participants |
Secondary
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
Time frame: 12 months
Population: 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 | Measure | Value (NUMBER) |
|---|---|---|
| TAXUS Libertē Post-Approval Study Enrolled Population | Target Vessel Failure (TVF) for the Medically-Treated Diabetic Population | 6.1 percentage of participants |