Clinical trial NCT00997503: TAXUS Libertē Post Approval Study
Official title: TAXUS Libertē Post Approval Study: A U.S. Post-Approval Study of the TAXUS® Liberté® Paclitaxel-Eluting Coronary Stent System
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Artery Disease
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
Collaborators: name: Eli Lilly and Company
name: Daiichi Sankyo
First posted: 2009-10-19
Enrollment: 4199
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All-comers study with follow-up through 3 years.

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.

Eligibility 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 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.

Primary outcomes:
measure: Cardiac Death or Myocardial Infarction
timeFrame: 12 months
Secondary outcomes:
measure: Incremental Rate of Stent Thrombosis (Protocol Definition)
timeFrame: 1-2 years
measure: Target Vessel Failure (TVF) for the Medically-Treated Diabetic Population
timeFrame: 12 months
measure: Rate of Major Adverse Cardiac and Cerebrovascular Events (MACCE)
timeFrame: 6 months
measure: Rate of Major Adverse Cardiac and Cerebrovascular Events (MACCE)
timeFrame: 12 months
measure: Rate of Major Adverse Cardiac & Cerebrovascular Events (MACCE): Study Stent Related
timeFrame: 6 months
measure: Rate of Major Adverse Cardiac and Cerebrovascular Events (MACCE): Study Stent Related
timeFrame: 12 months
measure: Rate of Major Adverse Cardiac Events (MACE)
timeFrame: 6 months
measure: Rate of Major Adverse Cardiac Events (MACE)
timeFrame: 12 months
measure: Rate of Major Adverse Cardiac Events (MACE): Study Stent Related
timeFrame: 6 months
measure: Rate of Major Adverse Cardiac Events (MACE): Study Stent Related
timeFrame: 12 months
measure: Rate of Target Vessel Failure (TVF)
timeFrame: 6 months
measure: Rate of Target Vessel Failure (TVF)
timeFrame: 12 months
measure: Rate of Cardiac Death or Myocardial Infarction (MI)
timeFrame: 6 months
measure: Rate of Cardiac Death or Myocardial Infarction (MI)
timeFrame: 12 months
measure: Rate of All Cause Death
timeFrame: 6 months
measure: Rate of All Cause Death
timeFrame: 12 months
measure: Rate of Cardiac Death
timeFrame: 6 months
measure: Rate of Cardiac Death
timeFrame: 12 months
measure: Rate of Cardiac Death: Study Stent Related
timeFrame: 6 months
measure: Rate of Cardiac Death: Study Stent Related
timeFrame: 12 months
measure: Rate of Myocardial Infarction (MI)
timeFrame: 6 months
measure: Rate of Myocardial Infarction (MI)
timeFrame: 12 months
measure: Rate of Myocardial Infarction (MI): Study Stent Related
timeFrame: 6 months
measure: Rate of Myocardial Infarction (MI): Study Stent Related
timeFrame: 12 months
measure: Rate of Target Vessel Reintervention (TVR)
timeFrame: 6 months
measure: Rate of Target Vessel Reintervention (TVR)
timeFrame: 12 months
measure: Rate of Target Vessel Reintervention (TVR): Study Stent Related
timeFrame: 6 months
measure: Rate of Target Vessel Reintervention (TVR): Study Stent Related
timeFrame: 12 months
measure: Rate of Stroke
timeFrame: 6 months
measure: Rate of Stroke
timeFrame: 12 months
measure: Rate of Major Bleeding
timeFrame: 6 months
measure: Rate of Major Bleeding
timeFrame: 12 months
measure: Rate of Stent Thrombosis (ARC Definite + Probable)
timeFrame: 6 months
measure: Rate of Stent Thrombosis (ARC Definite + Probable)
timeFrame: 12 months
measure: Rate of Stent Thrombosis (Protocol Definition)
timeFrame: 6 months
measure: Rate of Stent Thrombosis (Protocol Definition)
timeFrame: 12 months
Other outcomes:
Locations:
city: Mesa
country: United States
facility: Advanced Cardiac Specialists
state: Arizona
city: Jonesboro
country: United States
facility: NEA Baptist Memorial Hospital
state: Arkansas
city: Jonesboro
country: United States
facility: St. Bernard's Medical Center
state: Arkansas
city: Little Rock
country: United States
facility: Baptist Health Medical Center
state: Arkansas
city: Bakersfield
country: United States
facility: Bakersfield Memorial Hospital
state: California
city: Bakersfield
country: United States
facility: Bakersfield Heart
state: California
city: Sacramento
country: United States
facility: Mercy General Hospital
state: California
city: San Diego
country: United States
facility: Alvarado Hospital
state: California
city: Stanford
country: United States
facility: Stanford University Medical Center
state: California
city: Torrance
country: United States
facility: Torrance Memorial Medical Center
state: California
city: Denver
country: United States
facility: St. Anthony Central Hospital
state: Colorado
city: Loveland
country: United States
facility: Medical Center of the Rockies (Loveland)
state: Colorado
city: Bridgeport
country: United States
facility: St. Vincent's Medical Center
state: Connecticut
city: Newark
country: United States
facility: Christiana Hospital
state: Delaware
city: Atlantis
country: United States
facility: JFK Medical Center
state: Florida
city: Gainesville
country: United States
facility: North Florida Regional Medical Center
state: Florida
city: Jacksonville
country: United States
facility: Baptist Medical Center
state: Florida
city: Jacksonville
country: United States
facility: Memorial Hospital Jacksonville/ Orange Park Medical Center
state: Florida
city: Melbourne
country: United States
facility: Holmes Regional Medical Center
state: Florida
city: Orlando
country: United States
facility: Florida Hospital
state: Florida
city: Pensacola
country: United States
facility: Baptist Hospital
state: Florida
city: Pensacola
country: United States
facility: Sacred Heart Hospital
state: Florida
city: St. Petersburg
country: United States
facility: Bayfront Medical Center
state: Florida
city: Stuart
country: United States
facility: Martin Memorial Medical Center
state: Florida
city: Tampa
country: United States
facility: University Community Hospital
state: Florida
city: Honolulu
country: United States
facility: Kaiser Foundation Hospitals
state: Hawaii
city: Coeur d'Alene
country: United States
facility: Kootenai Medical Center
state: Idaho
city: Berwyn
country: United States
facility: MacNeal Hospital
state: Illinois
city: Chicago
country: United States
facility: Jesse Brown VA Medical Center
state: Illinois
city: Carmel
country: United States
facility: IU Health North Medical Center
state: Indiana
city: Indianapolis
country: United States
facility: Indiana Heart Hospital
state: Indiana
city: Ashland
country: United States
facility: King's Daughters Medical Center- Kentucky Heart Institute
state: Kentucky
city: Lexington
country: United States
facility: St. Joseph Hospital
state: Kentucky
city: Alexandria
country: United States
facility: Christus St. Frances Cabrini Hospital
state: Louisiana
city: Shreveport
country: United States
facility: Cardiovascular Research, LLC
state: Louisiana
city: Bangor
country: United States
facility: Eastern Maine Medical Center
state: Maine
city: Lewiston
country: United States
facility: Central Maine Medical Center
state: Maine
city: Grand Blanc
country: United States
facility: Genesys Regional Medical Center
state: Michigan
city: Lansing
country: United States
facility: Ingham Regional Medical Center
state: Michigan
city: Midland
country: United States
facility: Mid Michigan Medical Center
state: Michigan
city: Mt. Pleasant
country: United States
facility: St. Mary's Medical Center
state: Michigan
city: Petoskey
country: United States
facility: Northern Michigan Hospital
state: Michigan
city: Saginaw
country: United States
facility: Covenant Medical Center
state: Michigan
city: Southfield
country: United States
facility: Providence Hospital
state: Michigan
city: St. Joseph
country: United States
facility: Lakeland Hospital at St. Joseph
state: Michigan
city: Minneapolis
country: United States
facility: North Memorial Medical Center
state: Minnesota
city: St. Paul
country: United States
facility: United Heart and Vascular Clinic
state: Minnesota
city: Gulfport
country: United States
facility: Memorial Hospital at Gulfport
state: Mississippi
city: Tupelo
country: United States
facility: North Mississippi Medical Center
state: Mississippi
city: Joplin
country: United States
facility: Freeman West Hospital
state: Missouri
city: Springfield
country: United States
facility: Cox Medical Centers
state: Missouri
city: St. Louis
country: United States
facility: St. John's Mercy Medical Center
state: Missouri
city: Camden
country: United States
facility: Our Lady of Lourdes Medical Center
state: New Jersey
city: Hackensack
country: United States
facility: Hackensack University Medical Center
state: New Jersey
city: Neptune
country: United States
facility: Jersey Shore University Medical Center
state: New Jersey
city: Albuquerque
country: United States
facility: Heart Hospital of New Mexico
state: New Mexico
city: Brooklyn
country: United States
facility: Maimonides Medical Center
state: New York
city: New York
country: United States
facility: Lenox Hill Hospital
state: New York
city: New York
country: United States
facility: Columbia University/ New York Presbyterian Hospital
state: New York
city: Utica
country: United States
facility: St. Elizabeth Medical Center
state: New York
city: Gastonia
country: United States
facility: Gaston Memorial Hospital
state: North Carolina
city: Raleigh
country: United States
facility: Wake Medical Center
state: North Carolina
city: Columbus
country: United States
facility: Ohio State University Medical Center
state: Ohio
city: Mansfield
country: United States
facility: Med Central Health System- Mid Ohio Heart Clinic
state: Ohio
city: Toledo
country: United States
facility: St. Vincent Mercy Medical Center
state: Ohio
city: Oklahoma City
country: United States
facility: University of Oklahoma Health Science Center
state: Oklahoma
city: Oklahoma City
country: United States
facility: Oklahoma Heart Hospital
state: Oklahoma
city: Johnstown
country: United States
facility: Conemaugh Valley Memorial Hospital
state: Pennsylvania
city: Philadelphia
country: United States
facility: Presbyterian University of Pennsylvania Medical Center
state: Pennsylvania
city: Columbia
country: United States
facility: Palmetto Richland Memorial Hospital
state: South Carolina
city: Columbia
country: United States
facility: Sisters of Charity Providence Hospital
state: South Carolina
city: Myrtle Beach
country: United States
facility: Grand Strand Regional Medical Center
state: South Carolina
city: Rapid City
country: United States
facility: Rapid City Regional Hospital
state: South Dakota
city: Sioux Falls
country: United States
facility: Avera Heart Hospital of South Dakota
state: South Dakota
city: Jackson
country: United States
facility: Jackson Madison County General Hospital
state: Tennessee
city: Dallas
country: United States
facility: Baylor Jack and Jane Hamilton Heart and Vascular Hospital
state: Texas
city: Edinburg
country: United States
facility: Doctors Hospital at Renaissance/ McAllen Heart Hospital
state: Texas
city: Houston
country: United States
facility: Michael E. DeBakey VA Medical Center
state: Texas
city: Kingwood
country: United States
facility: Kingwood Medical Center
state: Texas
city: San Antonio
country: United States
facility: Methodist Texsan Hospital
state: Texas
city: Tyler
country: United States
facility: Cardiovascular Associates of East Texas Medical Center
state: Texas
city: Madison
country: United States
facility: Meriter Hospital, Inc.
state: Wisconsin
Study officials:
affiliation: Stanford University
name: David P Lee, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Lenox Hill Hospital
name: Kirk N Garratt, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Boston Scientific Corporation
name: Peter M Maurer, MPH
role: STUDY_DIRECTOR
References:
citation: Ellis SG, Vandormael MG, Cowley MJ, DiSciascio G, Deligonul U, Topol EJ, Bulle TM. Coronary morphologic and clinical determinants of procedural outcome with angioplasty for multivessel coronary disease. Implications for patient selection. Multivessel Angioplasty Prognosis Study Group. Circulation. 1990 Oct;82(4):1193-202. doi: 10.1161/01.cir.82.4.1193.
citation: 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
citation: 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.
citation: Garratt KN, Weaver WD, Jenkins RG, Pow TK, Mauri L, Kereiakes DJ, Winters KJ, Christen T, Allocco DJ, Lee DP. Prasugrel plus aspirin beyond 12 months is associated with improved outcomes after TAXUS Liberte paclitaxel-eluting coronary stent placement. Circulation. 2015 Jan 6;131(1):62-73. doi: 10.1161/CIRCULATIONAHA.114.013570. Epub 2014 Nov 16.