PROMUS Element Plus US Post-Approval Study

Coronary Artery Disease Clinical Trial

Official title:

A U.S. Post-Approval Study of the PROMUS Element™ Plus Everolimus-Eluting Platinum Chromium Coronary Stent System

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01589978
• Other study ID #: S2066
• Status: Completed
• Phase: Phase 4
• Start date: May 2012
• Est. completion date: June 2018

Study information

• Verified date: June 2018
• Source: Boston Scientific Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is designed to observe clinical outcomes in patients receiving the PROMUS Element Plus Everolimus-Eluting Platinum Chromium Coronary Stent System in routine clinical practice. Patients will have symptomatic heart disease or documented silent ischemia. This is a prospective, open-label consecutively-enrolling study. Clinical follow-up is through 5 years. Approximately 2,689 patients are to be enrolled in up to 65 centers in the United States.

Description:

The wide-spread use of drug-eluting stents (DES) has evolved as standard of care in de novo lesions. The PROMUS Element Plus Everolimus-Eluting Platinum Chromium Coronary Stent System is indicated for improving luminal diameter in patients with symptomatic heart disease or documented silent ischemia due to de novo lesions in native coronary arteries ≥2.25 mm to ≤4.00 mm in diameter in lesions ≤34 mm in length. The proposed study will compile real-world clinical outcomes data for the PROMUS Element Plus Everolimus-Eluting Platinum Chromium Coronary Stent System in routine clinical practice.

Patients enrolled in this study are expected to follow antiplatelet therapy recommendations per American College of Cardiology (ACC)/American Heart Association (AHA)/Society for Cardiovascular Angiography and Interventions (SCAI) guidelines for percutaneous coronary intervention (PCI). Recommended medications include aspirin, which should be taken for 3 days prior to the procedure or as a peri-procedural loading dose and then continued indefinitely. Additionally, one of the following P2Y12 antagonists may be given in a peri-procedural loading dose and in a maintenance dose per physician discretion: clopidogrel, prasugrel, ticagrelor, or ticlopidine.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2681
• Est. completion date: June 2018
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• The population will include consecutive, consented patients.

Exclusion Criteria:

• There are no exclusion criteria in this all-comers study.

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Device:
• PROMUS Element Plus Coronary Stent System
PROMUS Element is a device/drug combination product composed of two components, a device (coronary stent) and a drug product (a formulation of everolimus contained in a polymer coating).

Drug:
• Aspirin
Aspirin should be taken daily (81 mg) for 3 days prior to the procedure or as a peri-procedural loading dose of 250-500 mg. A maintenance dose of aspirin of at least 81 mg daily, or as indicated by the treating physician, should be continued indefinitely.
• P2Y12 antagonist
Patients to take one of the following P2Y12 antagonists; maintenance doses to be continued per ACC/AHA/SCAI guidelines for PCI. Clopidogrel: Per treating physician, peri-procedural loading dose (300-600 mg), subsequent maintenance dose (75 mg daily) Prasugrel: Per treating physician, peri-procedural loading dose (60 mg), subsequent maintenance dose (10 or 5 mg daily per product labeling) Ticagrelor: Per treating physician, peri-procedural loading dose (180 mg), subsequent maintenance dose (90 mg 2x daily); maintenance aspirin doses >100 mg may reduce ticagrelor effectiveness and should be avoided. Ticlopidine: Per treating physician, if allergy/intolerance to clopidogrel, prasugrel, and/or ticagrelor, loading dose (500 mg), subsequent maintenance dose (250 mg 2x daily)

Locations

Country	Name	City	State
United States	Piedmont Hospital	Atlanta	Georgia
United States	South Austin Hospital	Austin	Texas
United States	Eastern Maine Medical Center	Bangor	Maine
United States	Brandon Regional Hospital	Brandon	Florida
United States	IU Health North Medical Center	Carmel	Indiana
United States	Novant Health Presbyterian Medical Center	Charlotte	North Carolina
United States	Mercy Hospital	Coon Rapids	Minnesota
United States	Presbyterian Hospital of Dallas	Dallas	Texas
United States	VA North Texas Health Care System	Dallas	Texas
United States	Doylestown Hospital	Doylestown	Pennsylvania
United States	North Florida Regional Medical Center	Gainesville	Florida
United States	St. Francis Health System - St. Francis Hospital	Greenville	South Carolina
United States	University Medical Center-Greenville Memorial Hospital	Greenville	South Carolina
United States	Hackensack University Medical Center	Hackensack	New Jersey
United States	Forest County General Hospital	Hattiesburg	Mississippi
United States	Memorial Regional Hospital	Hollywood	Florida
United States	Huntsville Hospital - The Heart Center, PC	Huntsville	Alabama
United States	Cape Cod Hospital	Hyannis	Massachusetts
United States	Community Heart and Vascular Hospital	Indianapolis	Indiana
United States	Franciscan St. Francis Hospital	Indianapolis	Indiana
United States	NEA Baptist Memorial Hospital	Jonesboro	Arkansas
United States	St. Bernard's Medical Center	Jonesboro	Arkansas
United States	St. Joseph Hospital	Lexington	Kentucky
United States	Loma Linda University Medical Center	Loma Linda	California
United States	Coliseum Medical Center	Macon	Georgia
United States	Meriter Hospital	Madison	Wisconsin
United States	Mount Sinai Medical Center	Miami Beach	Florida
United States	North Memorial Medical Center	Minneapolis	Minnesota
United States	Springhill Medical Center	Mobile	Alabama
United States	Grand Strand Regional Medical Center	Myrtle Beach	South Carolina
United States	New York University Medical Center	New York	New York
United States	Christiana Hospital	Newark	Delaware
United States	Orlando Regional Medical Center	Orlando	Florida
United States	Bay Medical Center	Panama City	Florida
United States	Presbyterian University of Pennsylvania Medical Center	Philadelphia	Pennsylvania
United States	Blessing Hospital	Quincy	Illinois
United States	Rapid City Regional Hospital	Rapid City	South Dakota
United States	Chippenham Medical Center	Richmond	Virginia
United States	Carilion Roanoke Memorial Hospital	Roanoke	Virginia
United States	Redmond Regional Medical Center	Rome	Georgia
United States	Mercy General Hospital	Sacramento	California
United States	Lakeland Hospitals at St. Joseph	Saint Joseph	Michigan
United States	United Hospital - St. Paul Heart Clinic	Saint Paul	Minnesota
United States	University of Utah Hospital and Clinics	Salt Lake City	Utah
United States	Cardiovascular Research, LLC	Shreveport	Louisiana
United States	Avera Heart Hospital of South Dakota	Sioux Falls	South Dakota
United States	Cox Medical Centers	Springfield	Missouri
United States	St. John's Regional Health Center (Springfield)	Springfield	Missouri
United States	Martin Memorial Health Systems - Martin Memorial Medical Center	Stuart	Florida
United States	St. Francis Hospital	Tulsa	Oklahoma
United States	St. Elizabeth Medical Center	Utica	New York
United States	Marshfiled Clinic	Weston	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
Boston Scientific Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cardiac Death or Myocardial Infarction Rate in PLATINUM-like Patients	Cardiac death or myocardial infarction rate at 12 months post implantation in PLATINUM-like patients (no acute myocardial infarction, graft stenting, chronic total occlusion, in-stent restenosis, failed brachytherapy, bifurcation, ostial lesion, severe tortuosity, moderate/severe calcification, 3-vessel stenting, cardiogenic shock, left main disease, or acute/chronic renal dysfunction; lesion length =28 mm with reference vessel diameter =2.25 mm and <2.5 mm, or lesion length =24 mm with diameter =2.5 mm and =4.25 mm); statistical testing will assess if rate meets the performance goal (3.2%)	12 months
Secondary	Definite + Probable Stent Thrombosis (ST) Rate Based on Academic Research Consortium (ARC) Definition in PLATINUM-like Patients	ARC definite/probable ST rate in PLATINUM-like patients (no acute myocardial infarction, graft stenting, chronic total occlusion, in-stent restenosis, failed brachytherapy, bifurcation, ostial lesion, severe tortuosity, moderate/severe calcification, 3-vessel stenting, cardiogenic shock, left main disease, or acute/chronic renal dysfunction; lesion length =28 mm with reference vessel diameter =2.25 mm and <2.5 mm, or lesion length =24 mm with diameter =2.5 mm and =4.25 mm); statistical testing will assess if the annual ST rate increase after the first year meets the performance goal (1.0%)	12 months
Secondary	Definite + Probable Stent Thrombosis (ST) Rate Based on Academic Research Consortium (ARC) Definition in All Patients	DEFINITE ST: acute coronary syndrome and angiographic or pathologic evidence of stent thrombosis; PROBABLE ST: unexplained death within 30 days or target-vessel infarction without angiographic information ARC ST is reported as a cumulative value at different time points and within the different separate time points. Time 0 is the time point after the guide catheter has been removed. Acute ST: 0-24 hours after stent implantation; Subacute ST: >24 hours to 30 days post; late ST: >30 days to 1 year post; Very late ST: >1 year post; NOTE: Acute/subacute can be replaced by early ST (0-30 days)	=24 hours, 30 days, 180 days, annually through 5 years
Secondary	Rate of Longitudinal Stent Deformation	Compression/elongation of a stent along its long axis resulting from interaction with an ancillary device (e.g., guide catheter) which catches the stent end or an internal stent strut; can occur with advancement or withdrawal of ancillary device. Under fluoroscopy, longitudinal compression usually results in increased strut density and elongation in decreased strut density ('pseudo-fracture'); both can occur in the same stent.	Index Procedure
Secondary	Major Adverse Cardiac Event Rate (MACE)	Composite of cardiac death, myocardial infarction, and target vessel revascularization	=24 hours, 30 days, 180 days, annually through 5 years
Secondary	Rate of Major Adverse Cardiac Events Related to the PROMUS Element Stent	Composite of cardiac death, myocardial infarction, and target vessel revascularization related to the PROMUS Element stent	=24 hours, 30 days, 180 days, annually through 5 years
Secondary	Myocardial Infarction (MI) Rate	New Q-waves in =2 leads lasting =0.04 sec with creatine kinase myoglobin band(CK-MB) or troponin >upper limit of normal(ULN); if no new Q-waves total CK levels >3×ULN (peri-percutaneous coronary intervention [PCI]) or >2×ULN (spontaneous) with elevated CK-MB or troponin >3×ULN (peri-PCI) or >2×ULN (spontaneous) plus =one of the following: ECG changes indicating new ischemia (new ST-T changes, left bundle branch block), imaging evidence of new loss of viable myocardium, new regional wall motion abnormality. Similar for MI diagnosis post coronary artery bypass graft with CK-MB or troponin >5×ULN	=24 hours, 30 days, 180 days, annually through 5 years
Secondary	Rate of Myocardial Infarction (MI) Events Related to the PROMUS Element Stent	New Q-waves in =2 leads lasting =0.04 sec with creatine kinase myoglobin band(CK-MB) or troponin >upper limit of normal(ULN); if no new Q-waves total CK levels >3×ULN (peri-percutaneous coronary intervention [PCI]) or >2×ULN (spontaneous) with elevated CK-MB or troponin >3×ULN (peri-PCI) or >2×ULN (spontaneous) plus =one of the following: ECG changes indicating new ischemia (new ST-T changes, left bundle branch block), imaging evidence of new loss of viable myocardium, new regional wall motion abnormality. Similar for MI diagnosis post coronary artery bypass graft with CK-MB or troponin >5×ULN	=24 hours, 30 days, 180 days, annually through 5 years
Secondary	Cardiac Death Rate	Cardiac death is defined as death due to any of the following: acute myocardial infarction; cardiac perforation/pericardial tamponade; arrhythmia or conduction abnormality; cerebrovascular accident through hospital discharge or cerebrovascular accident suspected of being related to the procedure; death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery; any death in which a cardiac cause cannot be excluded	=24 hours, 30 days, 180 days, annually through 5 years
Secondary	Rate of Cardiac Death Events Related to the PROMUS Element Stent	Cardiac death is defined as death due to any of the following: acute myocardial infarction; cardiac perforation/pericardial tamponade; arrhythmia or conduction abnormality; cerebrovascular accident through hospital discharge or cerebrovascular accident suspected of being related to the procedure; death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery; any death in which a cardiac cause cannot be excluded	=24 hours, 30 days, 180 days, annually through 5 years
Secondary	Target Vessel Revascularization (TVR) Rate	Target vessel revascularization is defined as any attempted or successfully completed percutaneous or surgical revascularization of a target vessel.	=24 hours, 30 days, 180 days, annually through 5 years
Secondary	Rate of Target Vessel Revascularization (TVR) Events Related to the PROMUS Element Stent	Target vessel revascularization is defined as any attempted or successfully completed percutaneous or surgical revascularization of a target vessel.	=24 hours, 30 days, 180 days, annually through 5 years
Secondary	Cardiac Death or Myocardial Infarction (MI) Rate	See individual descriptions of events.	=24 hours, 30 days, 180 days, annually through 5 years
Secondary	Rate of Cardiac Death or Myocardial Infarction Events Related to the PROMUS Element Stent	See individual descriptions of events.	=24 hours, 30 days, 180 days, annually through 5 years
Secondary	Target Vessel Failure (TVF) Rate	Target vessel failure (TVF) is defined as any revascularization of the target vessel, myocardial infarction (MI) related to the target vessel, or death related to the target vessel.; For the purposes of this protocol, if it cannot be determined with certainty whether MI or death was related to the target vessel it will be considered TVF.	=24 hours, 30 days, 180 days, annually through 5 years
Secondary	Rate of Target Vessel Failure (TVF) Related to the PROMUS Element Stent	Target vessel failure (TVF) is defined as any revascularization of the target vessel, myocardial infarction (MI) related to the target vessel, or death related to the target vessel.; For the purposes of this protocol, if it cannot be determined with certainty whether MI or death was related to the target vessel it will be considered TVF.	=24 hours, 30 days, 180 days, annually through 5 years
Secondary	All Death Rate	All death includes cardiac death and non-cardiac death.	=24 hours, 30 days, 180 days, annually through 5 years
Secondary	Non-cardiac Death Rate	Non-cardiac death is defined as death not due to cardiac causes.; Cardiac death is death due to any of the following: acute myocardial infarction; cardiac perforation/pericardial tamponade; arrhythmia or conduction abnormality; cerebrovascular accident through hospital discharge or cerebrovascular accident suspected of being related to the procedure; death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery; any death in which a cardiac cause cannot be excluded.	=24 hours, 30 days, 180 days, annually through 5 years
Secondary	All Death or Myocardial Infarction Rate	See description of individual events.	=24 hours, 30 days, 180 days, annually through 5 years
Secondary	Target Vessel Failure (TVF) Rate in PLATINUM-like Medically Treated Diabetic Patients	Any revascularization of the target vessel, myocardial infarction related to the target vessel, or death related to the target vessel. See individual components for descriptions. Statistical testing will determine if the rate meets the performance goal (12.6%)	12 Months
Secondary	ARC ST Rate in PLATINUM-like Population.	Using the Academic Research Consortium (ARC) definition, the (definite/probable) stent thrombosis (ST) rate in the PLATINUM-like* population will be analyzed. Statistical testing will be used to determine if the annual increase after the first year in ST rates observed in PLATINUM-like patients meets the performance goal of 1.0% (expected rate of 0.4% + a delta of 0.6%).	Annually through 5 years