PROMUS Element Plus US Post-Approval Study

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

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.

Study Overview

• Status: Completed
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Device: PROMUS Element Plus Coronary Stent System; Drug: Aspirin; Drug: P2Y12 antagonist

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 2681
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Huntsville, Alabama, United States, 35801
      • Huntsville Hospital - The Heart Center, PC
    • Mobile, Alabama, United States, 36608
      • Springhill Medical Center
  • Arkansas
    • Jonesboro, Arkansas, United States, 72401
      • NEA Baptist Memorial Hospital
    • Jonesboro, Arkansas, United States, 72401
      • St. Bernard's Medical Center
  • California
    • Loma Linda, California, United States, 92354
      • Loma Linda University Medical Center
    • Sacramento, California, United States, 95819
      • Mercy General Hospital
  • Delaware
    • Newark, Delaware, United States, 19718
      • Christiana Hospital
  • Florida
    • Brandon, Florida, United States, 33511
      • Brandon Regional Hospital
    • Gainesville, Florida, United States, 32605
      • North Florida Regional Medical Center
    • Hollywood, Florida, United States, 33021
      • Memorial Regional Hospital
    • Miami Beach, Florida, United States, 33140
      • Mount Sinai Medical Center
    • Orlando, Florida, United States, 32806
      • Orlando Regional Medical Center
    • Panama City, Florida, United States, 32401
      • Bay Medical Center
    • Stuart, Florida, United States, 34996
      • Martin Memorial Health Systems - Martin Memorial Medical Center
  • Georgia
    • Atlanta, Georgia, United States, 30309
      • Piedmont Hospital
    • Macon, Georgia, United States, 31217
      • Coliseum Medical Center
    • Rome, Georgia, United States, 30165
      • Redmond Regional Medical Center
  • Illinois
    • Quincy, Illinois, United States, 62301
      • Blessing Hospital
  • Indiana
    • Carmel, Indiana, United States, 46032
      • IU Health North Medical Center
    • Indianapolis, Indiana, United States, 46250
      • Community Heart and Vascular Hospital
    • Indianapolis, Indiana, United States, 46237
      • Franciscan St. Francis Hospital
  • Kentucky
    • Lexington, Kentucky, United States, 40504
      • St. Joseph Hospital
  • Louisiana
    • Shreveport, Louisiana, United States, 71103
      • Cardiovascular Research, LLC
  • Maine
    • Bangor, Maine, United States, 04401
      • Eastern Maine Medical Center
  • Massachusetts
    • Hyannis, Massachusetts, United States, 02601
      • Cape Cod Hospital
  • Michigan
    • Saint Joseph, Michigan, United States, 49085
      • Lakeland Hospitals at St. Joseph
  • Minnesota
    • Coon Rapids, Minnesota, United States, 55433
      • Mercy Hospital
    • Minneapolis, Minnesota, United States, 55422
      • North Memorial Medical Center
    • Saint Paul, Minnesota, United States, 55102
      • United Hospital - St. Paul Heart Clinic
  • Mississippi
    • Hattiesburg, Mississippi, United States, 39401
      • Forest County General Hospital
  • Missouri
    • Springfield, Missouri, United States, 65807
      • Cox Medical Centers
    • Springfield, Missouri, United States, 65804
      • St. John's Regional Health Center (Springfield)
  • New Jersey
    • Hackensack, New Jersey, United States, 07601
      • Hackensack University Medical Center
  • New York
    • New York, New York, United States, 10011
      • New York University Medical Center
    • Utica, New York, United States, 13501
      • St. Elizabeth Medical Center
  • North Carolina
    • Charlotte, North Carolina, United States, 28204
      • Novant Health Presbyterian Medical Center
  • Oklahoma
    • Tulsa, Oklahoma, United States, 74136
      • St. Francis Hospital
  • Pennsylvania
    • Doylestown, Pennsylvania, United States, 18901
      • Doylestown Hospital
    • Philadelphia, Pennsylvania, United States, 19104
      • Presbyterian University of Pennsylvania Medical Center
  • South Carolina
    • Greenville, South Carolina, United States, 29605
      • University Medical Center-Greenville Memorial Hospital
    • Greenville, South Carolina, United States, 29607
      • St. Francis Health System - St. Francis Hospital
    • Myrtle Beach, South Carolina, United States, 29572
      • Grand Strand Regional Medical Center
  • South Dakota
    • Rapid City, South Dakota, United States, 57701
      • Rapid City Regional Hospital
    • Sioux Falls, South Dakota, United States, 57108
      • Avera Heart Hospital of South Dakota
  • Texas
    • Austin, Texas, United States, 78745
      • South Austin Hospital
    • Dallas, Texas, United States, 75216
      • VA North Texas Health Care System
    • Dallas, Texas, United States, 75231
      • Presbyterian Hospital of Dallas
  • Utah
    • Salt Lake City, Utah, United States, 84132
      • University of Utah Hospital and Clinics
  • Virginia
    • Richmond, Virginia, United States, 23225
      • Chippenham Medical Center
    • Roanoke, Virginia, United States, 24014
      • Carilion Roanoke Memorial Hospital
  • Wisconsin
    • Madison, Wisconsin, United States, 53713
      • Meriter Hospital
    • Weston, Wisconsin, United States, 55476
      • Marshfiled Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• The population will include consecutive, consented patients.

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

EXPERIMENTAL: PROMUS Element; Subjects who receive the PROMUS Element everolimus-eluting coronary stent

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).; Other Names: PROMUS Element stent; 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.; Other Names: Acetyl salicylic acid; Drug: 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); Other Names: PLAVIX (clopidogrel); TICLID (ticlopidine); EFFIENT (prasugrel); BRILINTA (ticagrelor)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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
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
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
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
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
Cardiac Death or Myocardial Infarction (MI) Rate	See individual descriptions of events.	≤24 hours, 30 days, 180 days, annually through 5 years
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
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
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
All Death Rate	All death includes cardiac death and non-cardiac death.	≤24 hours, 30 days, 180 days, annually through 5 years
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
All Death or Myocardial Infarction Rate	See description of individual events.	≤24 hours, 30 days, 180 days, annually through 5 years
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
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

Collaborators and Investigators

• Sponsor: Boston Scientific Corporation

Publications and helpful links

General Publications

• Batchelor WB, Damluji AA, Yong C, Fiuzat M, Barnett SD, Kandzari DE, Sherwood MW, Epps KC, Tehrani BN, Allocco DJ, Meredith IT, Lindenfeld J, O'Connor CM, Mehran R. Does study subject diversity influence cardiology research site performance?: Insights from 2 U.S. National Coronary Stent Registries. Am Heart J. 2021 Jun;236:37-48. doi: 10.1016/j.ahj.2021.02.003. Epub 2021 Feb 24.
• Kandzari DE, Amjadi N, Caputo C, Rowe SK, Williams J, Tamboli HP, Christen T, Allocco DJ, Dawkins KD. One-Year Outcomes in "Real-World" Patients Treated With a Thin-Strut, Platinum-Chromium, Everolimus-Eluting Stent (from the PROMUS Element Plus US Post-Approval Study [PE-Plus PAS]). Am J Cardiol. 2016 Feb 15;117(4):539-545. doi: 10.1016/j.amjcard.2015.11.043. Epub 2015 Dec 7.

Study record dates

Study Major Dates

• Study Start: May 1, 2012
• Primary Completion (ACTUAL): August 1, 2014
• Study Completion (ACTUAL): June 1, 2018

Study Registration Dates

• First Submitted: May 1, 2012
• First Submitted That Met QC Criteria: May 1, 2012
• First Posted (ESTIMATE): May 2, 2012

Study Record Updates

• Last Update Posted (ACTUAL): July 26, 2018
• Last Update Submitted That Met QC Criteria: June 27, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Keywords: atherosclerosis; drug-eluting stent; everolimus; DES
• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Fibrinolytic Agents; Fibrin Modulating Agents; Platelet Aggregation Inhibitors; Cyclooxygenase Inhibitors; Antipyretics; Purinergic P2Y Receptor Antagonists; Purinergic P2 Receptor Antagonists; Purinergic Antagonists; Purinergic Agents; Dermatologic Agents; Cytochrome P-450 Enzyme Inhibitors; Antifungal Agents; Keratolytic Agents; Cytochrome P-450 CYP2C19 Inhibitors; Aspirin; Ticagrelor; Clopidogrel; Salicylic Acid; Prasugrel Hydrochloride; Salicylates; Ticlopidine
• Other Study ID Numbers: S2066