TAXUS Libertē Post Approval Study

Coronary Artery Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00997503
• Other study ID #: H7T-MC-TADN
• Secondary ID: S2035
• Status: Completed
• Phase: Phase 4
• First received: October 15, 2009
• Last updated: July 20, 2015
• Start date: December 2009
• Est. completion date: July 2015

Study information

• Verified date: March 2015
• Source: Boston Scientific Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4199
• Est. completion date: July 2015
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

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
• placebo
Oral placebo to match both 10mg and 5mg prasugrel tablets.
• aspirin
Oral, as prescribed by physician through end of study.

Locations

Country	Name	City	State
United States	Heart Hospital of New Mexico	Albuquerque	New Mexico
United States	Christus St. Frances Cabrini Hospital	Alexandria	Louisiana
United States	King's Daughters Medical Center- Kentucky Heart Institute	Ashland	Kentucky
United States	JFK Medical Center	Atlantis	Florida
United States	Bakersfield Heart	Bakersfield	California
United States	Bakersfield Memorial Hospital	Bakersfield	California
United States	Eastern Maine Medical Center	Bangor	Maine
United States	MacNeal Hospital	Berwyn	Illinois
United States	St. Vincent's Medical Center	Bridgeport	Connecticut
United States	Maimonides Medical Center	Brooklyn	New York
United States	Our Lady of Lourdes Medical Center	Camden	New Jersey
United States	IU Health North Medical Center	Carmel	Indiana
United States	Jesse Brown VA Medical Center	Chicago	Illinois
United States	Kootenai Medical Center	Coeur d'Alene	Idaho
United States	Palmetto Richland Memorial Hospital	Columbia	South Carolina
United States	Sisters of Charity Providence Hospital	Columbia	South Carolina
United States	Ohio State University Medical Center	Columbus	Ohio
United States	Baylor Jack and Jane Hamilton Heart and Vascular Hospital	Dallas	Texas
United States	St. Anthony Central Hospital	Denver	Colorado
United States	Doctors Hospital at Renaissance/ McAllen Heart Hospital	Edinburg	Texas
United States	North Florida Regional Medical Center	Gainesville	Florida
United States	Gaston Memorial Hospital	Gastonia	North Carolina
United States	Genesys Regional Medical Center	Grand Blanc	Michigan
United States	Memorial Hospital at Gulfport	Gulfport	Mississippi
United States	Hackensack University Medical Center	Hackensack	New Jersey
United States	Kaiser Foundation Hospitals	Honolulu	Hawaii
United States	Michael E. DeBakey VA Medical Center	Houston	Texas
United States	Indiana Heart Hospital	Indianapolis	Indiana
United States	Jackson Madison County General Hospital	Jackson	Tennessee
United States	Baptist Medical Center	Jacksonville	Florida
United States	Memorial Hospital Jacksonville/ Orange Park Medical Center	Jacksonville	Florida
United States	Conemaugh Valley Memorial Hospital	Johnstown	Pennsylvania
United States	NEA Baptist Memorial Hospital	Jonesboro	Arkansas
United States	St. Bernard's Medical Center	Jonesboro	Arkansas
United States	Freeman West Hospital	Joplin	Missouri
United States	Kingwood Medical Center	Kingwood	Texas
United States	Ingham Regional Medical Center	Lansing	Michigan
United States	Central Maine Medical Center	Lewiston	Maine
United States	St. Joseph Hospital	Lexington	Kentucky
United States	Baptist Health Medical Center	Little Rock	Arkansas
United States	Medical Center of the Rockies (Loveland)	Loveland	Colorado
United States	Meriter Hospital, Inc.	Madison	Wisconsin
United States	Med Central Health System- Mid Ohio Heart Clinic	Mansfield	Ohio
United States	Holmes Regional Medical Center	Melbourne	Florida
United States	Advanced Cardiac Specialists	Mesa	Arizona
United States	Mid Michigan Medical Center	Midland	Michigan
United States	North Memorial Medical Center	Minneapolis	Minnesota
United States	St. Mary's Medical Center	Mt. Pleasant	Michigan
United States	Grand Strand Regional Medical Center	Myrtle Beach	South Carolina
United States	Jersey Shore University Medical Center	Neptune	New Jersey
United States	Columbia University/ New York Presbyterian Hospital	New York	New York
United States	Lenox Hill Hospital	New York	New York
United States	Christiana Hospital	Newark	Delaware
United States	Oklahoma Heart Hospital	Oklahoma City	Oklahoma
United States	University of Oklahoma Health Science Center	Oklahoma City	Oklahoma
United States	Florida Hospital	Orlando	Florida
United States	Baptist Hospital	Pensacola	Florida
United States	Sacred Heart Hospital	Pensacola	Florida
United States	Northern Michigan Hospital	Petoskey	Michigan
United States	Presbyterian University of Pennsylvania Medical Center	Philadelphia	Pennsylvania
United States	Wake Medical Center	Raleigh	North Carolina
United States	Rapid City Regional Hospital	Rapid City	South Dakota
United States	Mercy General Hospital	Sacramento	California
United States	Covenant Medical Center	Saginaw	Michigan
United States	Methodist Texsan Hospital	San Antonio	Texas
United States	Alvarado Hospital	San Diego	California
United States	Cardiovascular Research, LLC	Shreveport	Louisiana
United States	Avera Heart Hospital of South Dakota	Sioux Falls	South Dakota
United States	Providence Hospital	Southfield	Michigan
United States	Cox Medical Centers	Springfield	Missouri
United States	Lakeland Hospital at St. Joseph	St. Joseph	Michigan
United States	St. John's Mercy Medical Center	St. Louis	Missouri
United States	United Heart and Vascular Clinic	St. Paul	Minnesota
United States	Bayfront Medical Center	St. Petersburg	Florida
United States	Stanford University Medical Center	Stanford	California
United States	Martin Memorial Medical Center	Stuart	Florida
United States	University Community Hospital	Tampa	Florida
United States	St. Vincent Mercy Medical Center	Toledo	Ohio
United States	Torrance Memorial Medical Center	Torrance	California
United States	North Mississippi Medical Center	Tupelo	Mississippi
United States	Cardiovascular Associates of East Texas Medical Center	Tyler	Texas
United States	St. Elizabeth Medical Center	Utica	New York

Sponsors (3)

Lead Sponsor	Collaborator
Boston Scientific Corporation	Daiichi Sankyo Inc., Eli Lilly and Company

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View 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

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 Liberte post-approval study. Journal of the American College of Cardiology. 2013;62:B54-B54

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	12 months	Yes
Secondary	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	Yes
Secondary	Target Vessel Failure (TVF) for the Medically-Treated Diabetic Population	Target vessel failure (TVF) for TAXUS Liberte Post-Approval Study medically-treated diabetic population. For pooled data from the TAXUS Liberté population, please see the citations	12 months	Yes
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	6 months	Yes
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	12 months	Yes
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.	6 months	Yes
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	12 months	Yes
Secondary	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	Yes
Secondary	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	Yes
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	6 months	Yes
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	12 months	Yes
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	6 months	Yes
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	12 months	Yes
Secondary	Rate of Cardiac Death or Myocardial Infarction (MI)	- Binary Rate	6 months	Yes
Secondary	Rate of Cardiac Death or Myocardial Infarction (MI)	- Binary Rate	12 months	Yes
Secondary	Rate of All Cause Death	-Binary rate	6 months	Yes
Secondary	Rate of All Cause Death	-Binary rate	12 months	Yes
Secondary	Rate of Cardiac Death	-Binary rate	6 months	Yes
Secondary	Rate of Cardiac Death	-Binary rate	12 months	Yes
Secondary	Rate of Cardiac Death: Study Stent Related	-Binary rate	6 months	Yes
Secondary	Rate of Cardiac Death: Study Stent Related	-Binary rate	12 months	Yes
Secondary	Rate of Myocardial Infarction (MI)	-Binary rate	6 months	Yes
Secondary	Rate of Myocardial Infarction (MI)	-Binary rate	12 months	Yes
Secondary	Rate of Myocardial Infarction (MI): Study Stent Related	-Binary rate	6 months	Yes
Secondary	Rate of Myocardial Infarction (MI): Study Stent Related	-Binary rate	12 months	Yes
Secondary	Rate of Target Vessel Reintervention (TVR)	-Binary rate	6 months	No
Secondary	Rate of Target Vessel Reintervention (TVR)	-Binary rate	12 months	No
Secondary	Rate of Target Vessel Reintervention (TVR): Study Stent Related	-Binary rate	6 months	No
Secondary	Rate of Target Vessel Reintervention (TVR): Study Stent Related	-Binary rate	12 months	No
Secondary	Rate of Stroke	-Binary Rate	6 months	Yes
Secondary	Rate of Stroke	-Binary Rate	12 months	Yes
Secondary	Rate of Major Bleeding	Major Bleeding defined as the composite of severe or moderate bleeding complication (based upon GUSTO classification).; Binary rate	6 months	Yes
Secondary	Rate of Major Bleeding	Major Bleeding defined as the composite of severe or moderate bleeding complication (based upon GUSTO classification).; Binary rate	12 months	Yes
Secondary	Rate of Stent Thrombosis (ARC Definite + Probable)	ARC - Academic Research Consortium; Binary rate	6 months	Yes
Secondary	Rate of Stent Thrombosis (ARC Definite + Probable)	ARC - Academic Research Consortium; Binary Rate	12 months	Yes
Secondary	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	Yes
Secondary	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	Yes