The PLATINUM Clinical Trial to Assess the PROMUS Element Stent System for Treatment of De Novo Coronary Artery Lesions (PLATINUM)

PLATINUM: A Prospective, Randomized, Multicenter Trial to Assess an Everolimus-Eluting Coronary Stent System (PROMUS Element™) for the Treatment of up to Two De Novo Coronary Artery Lesions

The purpose of this study is to evaluate the safety and effectiveness of the PROMUS Element™ Everolimus-Eluting Coronary Stent System for the treatment of patients with up to 2 de novo atherosclerotic coronary artery lesions.

This clinical trial compares outcomes in patients treated with PROMUS Element to those in patients treated with a different everolimus-eluting coronary stent. The lesions are of average length in average-sized vessels ("workhorse"). A companion sub-trial evaluates outcomes in smaller vessels (SV) and another sub-trial evaluates outcomes in longer lesions (LL).

Study Overview

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

Detailed Description

The wide-spread use of DES has evolved as standard of care in de novo lesions. The proposed study will evaluate the safety and effectiveness of PROMUS Element for the treatment of de novo atherosclerotic lesions in native coronary arteries. The study design is consistent with the draft guidance for industry titled, "Coronary Drug-Eluting Stents - Nonclinical and Clinical Studies" (March 2008).

During the trial, thienopyridines must be administered according to the 2007 American College of Cardiology (ACC)/American Heart Association (AHA)/Society for Cardiovascular Angiography and Interventions (SCAI) guidelines, which recommended that clopidogrel (75 mg daily) or ticlopidine (250 mg twice daily) be prescribed after stent implantation for at least 6 months in all patients, and for at least 12 months in patients who are not at high risk of bleeding. For sites in the United States, the use of prasugrel is not allowed as part of the PLATINUM Clinical Trial. For sites in other countries, prasugrel may be prescribed according to its approved dosing in countries in which it is available. For patients taking aspirin daily a loading dose is recommended; for patients who have not been taking aspirin daily, aspirin must be administered as a loading dose. Patients continue to take aspirin indefinitely to reduce the risk of thrombosis.

The main study is the PLATINUM Workhorse Randomized Controlled Trial, which is registered under NCT00823212. The clinical protocol includes two companion sub-trials with smaller vessels (PLATINUM SV) and longer lesions (PLATINUM LL) plus a Pharmacokinetics sub-trial (PLATINUM PK). The three sub-trials are registered under separate NCT numbers.

• Study Type: Interventional
• Enrollment (Actual): 1530
• Phase: Phase 3

Contacts and Locations

Study Locations

• Australia
  • Perth, Australia, 6000
    • Royal Perth Hospital
  • Queensland, Australia, 4032
    • The Prince Charles Hospital
  • Victoria
    • Clayton, Victoria, Australia, 3168
      • Monash Medical Centre
    • Fitzroy, Victoria, Australia, 3065
      • St. Vincent's Hospital
• Austria
  • Vienna, Austria, A-1090
    • Allgemeines Krankenhauas AKH
• Belgium
  • Antwerpen, Belgium, B-2020
    • Academisch Ziekenhuis Middelheim
  • Genk, Belgium, 3600
    • Ziekenhuis Oost Limburg
  • Gent, Belgium, B-9000
    • Universitair Ziekenhuis Gent
  • Leuven, Belgium, B-3000
    • Uz Gasthuisberg
• Denmark
  • Aarhus, Denmark, D-8200
    • Skejby Sygehus
  • Copenhagen, Denmark, 2100
    • Rigshospitalet Copenhagen
• Finland
  • Oulu, Finland, 90029
    • Oulu University Hospital
  • Tampere, Finland, 33521
    • Tampere University Hospital
  • Turku, Finland, 20521
    • Turku University Hospital
• France
  • Besancon, France, 25030
    • CHU de Besancon
  • Bordeaux, France, 33000
    • Clinique St. Augustin
  • Massy, France, 91300
    • Institut Cardiovasculaire - Paris Sud / Institut Hospitalier Jacques Cartier
  • Montpellier, France, 34960
    • Clinique du Millénaire
  • Toulouse, France, 31076
    • Clinique Pasteur
  • Toulouse, France, 31059
    • Centre Hôpital Universitaire Rangueil
• Germany
  • Bad Nauheim, Germany, 61231
    • Kerckhoff Klinik
  • Bad Oeynhausen, Germany, 32545
    • Herz-und Diabeteszentrum Nordrhein-Westfalen
  • Bad Segeberg, Germany, 23795
    • Herz-Kreislauf-Zentrum Segeberger Kliniken GmbH
  • Berlin, Germany, 10117
    • Universitatsklinik Charite Berlin
  • Heidelberg, Germany, 69120
    • Universitat Heidelberg
  • Leipzig, Germany, 04289
    • Herzzentrum Universität Leipzig
• Japan
  • Osaka, Japan, 530-0001
    • Sakurabashi Watanabe Hospital
  • Fukuoka
    • Kitakyushu-shi, Fukuoka, Japan
      • Kokura Memorial Hospital
  • Hokkaido
    • Sapporo-shi, Hokkaido, Japan
      • Japan Community Health Care Organization Hokkaido Hospital
  • Kanagawa
    • Kamakura-shi, Kanagawa, Japan
      • Shonan Kamakura General Hospital
    • Yokohama-shi, Kanagawa, Japan
      • Saiseikai Yokohama-City Eastern Hospital
  • Tokyo
    • Fuchu-shi, Tokyo, Japan
      • Sakakibara Heart Institute, Japan Research Promotion Society for Cardiovascular Diseases
    • Itabashi-ku, Tokyo, Japan
      • Teikyo University Hospital
    • Meguro-ku, Tokyo, Japan
      • Toho University Ohashi Medical Center
    • Minato-ku, Tokyo, Japan
      • The Cardiovascular Institute Hospital
    • Shinjuku-ku, Tokyo, Japan
      • Tokyo Women's Medical University Hospital
• Latvia
  • Riga, Latvia
    • P. Stradins University Hospital
• Malaysia
  • Kuala Lumpur, Malaysia, 50400
    • Institut Jantung Negara
  • Sarawak
    • Kota Samarahan, Sarawak, Malaysia, 94300
      • Sarawak General Hospital
• Netherlands
  • Alkmaar, Netherlands, 1815 JD
    • Medisch Centrum Alkmaar
  • Breda, Netherlands, 4818CK
    • Amphia Ziekenhuis
  • Eindhoven, Netherlands, 5623 EJ
    • Catherina Ziekenhuis
  • Nieuwegein, Netherlands, 3435 CM
    • St Antonius Ziekenhuis
• New Zealand
  • Auckland, New Zealand, 1051
    • Ascot Angiography
  • Wellington, New Zealand, 6021
    • Wellington Hospital
  • Auckland
    • Otahuhu, Auckland, New Zealand, 1640
      • Middlemore Hospital
• Poland
  • Bydgoszcz, Poland, 85-094
    • Szpital Uniwersytecki
  • Krakow, Poland, 31-501
    • SPZOZ Szpital Uniwersytecki w Krakowie
  • Warsaw, Poland, 04-628
    • National Institute of Cardiology
  • Wroklaw, Poland, 50-891
    • Military Hospital
• Portugal
  • Carnaxide, Portugal, 2799-532
    • Hospital de Santa Cruz
• Singapore
  • Singapore, Singapore, 168752
    • National Heart Centre Singapore
• United Kingdom
  • Clydebank, United Kingdom, G81 4HX
    • Golden Jubilee National Hospital
  • Southampton, United Kingdom, SO16 6YD
    • Southampton University Hospital
  • England
    • London, England, United Kingdom, SE1 7EH
      • Guys and St. Thomas NHS Foundation Trust St. Thomas Hospital
    • Middlesbrough, England, United Kingdom, TS4 3BW
      • James Cook University Hospital
    • Oxford, England, United Kingdom, OX3 9DU
      • John Radcliffe Infirmary Oxford II
  • Ireland
    • Belfast, Ireland, United Kingdom, BT12 6BA
      • Royal Victoria Hospital
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35211
      • Baptist Medical Center Princeton
  • Arizona
    • Phoenix, Arizona, United States, 85006
      • Banner Good Samaritan Regional Medical Center
  • Arkansas
    • Little Rock, Arkansas, United States, 72211
      • Arkansas Heart Hospital
  • California
    • Bakersfield, California, United States, 93301
      • Bakersfield Memorial Hospital
    • La Jolla, California, United States, 92037
      • Scripps Clinic
    • Los Angeles, California, United States, 90017
      • Good Samaritan Hospital
    • Sacramento, California, United States, 95817
      • University of California Davis Medical Center
    • Sacramento, California, United States, 95819
      • Mercy General Hospital
    • San Diego, California, United States, 92103
      • University of California San Diego
    • San Diego, California, United States, 92120
      • Alvarado Hospital
  • Colorado
    • Littleton, Colorado, United States, 80120
      • South Denver Cardiology Associates, PC
    • Loveland, Colorado, United States, 80538
      • Medical Center of the Rockies (Loveland)
  • Florida
    • Fort Lauderdale, Florida, United States, 33308
      • Holy Cross Hospital
    • Ocala, Florida, United States, 34471
      • MediQuest Research Group Inc. at Munroe Regional Medical Center
    • Orlando, Florida, United States, 32803
      • Florida Hospital
    • Tallahassee, Florida, United States, 32308
      • Tallahassee Memorial Hospital
  • Georgia
    • Macon, Georgia, United States, 31201
      • Medical Center of Central Georgia
  • Illinois
    • Springfield, Illinois, United States, 62769
      • St. John's Hospital
    • Springfield, Illinois, United States, 62702
      • Southern Illinois University Memorial Medical Center
  • Indiana
    • Indianapolis, Indiana, United States, 46260
      • St. Vincent's Hospital
    • Indianapolis, Indiana, United States, 46202
      • Krannert Institute of Cardiology
  • Iowa
    • Des Moines, Iowa, United States, 50314
      • Mercy Hospital Medical Center
  • Kentucky
    • Louisville, Kentucky, United States, 40202
      • Jewish Hospital and St. Mary's Healthcare
  • Maine
    • Portland, Maine, United States, 04102
      • Maine Medical Center
  • Maryland
    • Baltimore, Maryland, United States, 21218
      • Union Memorial Hospital
    • Takoma Park, Maryland, United States, 20912
      • Washington Adventist Hospital
  • Massachusetts
    • Boston, Massachusetts, United States, 02111
      • Tufts Medical Center
    • Springfield, Massachusetts, United States, 01199
      • Baystate Medical Center
  • Michigan
    • Grand Blanc, Michigan, United States, 48439
      • Genesys Regional Medical Center
    • Grand Rapids, Michigan, United States, 49503
      • Spectrum Health Hospitals
    • Petoskey, Michigan, United States, 49770
      • Northern Michigan Hospital
    • Royal Oak, Michigan, United States, 48073
      • William Beaumont Hospital
  • Minnesota
    • Duluth, Minnesota, United States, 55805
      • St. Mary's Duluth Clinic Regional Heart Center
    • Minneapolis, Minnesota, United States, 55407
      • Abbott Northwestern Hospital
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic Foundation
  • Mississippi
    • Tupelo, Mississippi, United States, 38801
      • North Mississippi Medical Center
  • Missouri
    • Kansas City, Missouri, United States, 64111
      • St. Luke's Hospital / Mid America Heart Institute
    • Saint Louis, Missouri, United States, 63110
      • Washington University School of Medicine
    • Saint Louis, Missouri, United States, 63131
      • Missouri Baptist Medical Center
  • Nebraska
    • Lincoln, Nebraska, United States, 68526
      • Nebraska Heart Institute
  • New Jersey
    • Camden, New Jersey, United States, 08103
      • Our Lady of Lourdes Medical Center
    • Camden, New Jersey, United States, 08103
      • Cooper Hospital/University Medical Center
  • New York
    • Brooklyn, New York, United States, 11219
      • Maimonides Medical Center
    • Buffalo, New York, United States, 14209
      • Kaleida Health
    • New York, New York, United States, 10032
      • Columbia University Medical Center
    • New York, New York, United States, 10029
      • Mount Sinai School Medical Center
    • Roslyn, New York, United States, 11576
      • St. Francis Hospital
  • North Carolina
    • Greensboro, North Carolina, United States, 27401
      • Moses H. Cone Memorial Hospital/LeBauer Cardiovascular Research Foundation
    • Raleigh, North Carolina, United States, 27610
      • Wake Medical Center
    • Winston-Salem, North Carolina, United States, 27157
      • Wake Forest University School of Medicine
  • Ohio
    • Cincinnati, Ohio, United States, 45220
      • Good Samaritan Hospital
    • Cincinnati, Ohio, United States, 45219
      • Lindner Center for Research and Education at The Christ Hospital
    • Columbus, Ohio, United States, 43210
      • Ohio State University Medical Center
    • Columbus, Ohio, United States, 43214
      • Ohio Health Research and Innovation Institute
    • Sandusky, Ohio, United States, 44870
      • Firelands Regional Medical Center
    • Toledo, Ohio, United States, 43608
      • Mercy St. Vincent Medical Center
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73120
      • Oklahoma Heart Hospital
  • Oregon
    • Portland, Oregon, United States, 97225
      • Providence St. Vincent Medical Center
  • Pennsylvania
    • Bryn Mawr, Pennsylvania, United States, 19010
      • Lankenau Institute for Medical Research
    • Harrisburg, Pennsylvania, United States, 17105
      • Pinnacle Health at Harrisburg Hospital
    • Hershey, Pennsylvania, United States, 17033
      • Penn State Milton S Hershey Medical Center
  • South Carolina
    • Columbia, South Carolina, United States, 29204
      • Sisters of Charity Providence Hospital
  • Tennessee
    • Jackson, Tennessee, United States, 38301
      • Jackson-Madison County General Hospital
    • Memphis, Tennessee, United States, 38120
      • Baptist Memorial Hospital
  • Texas
    • Austin, Texas, United States, 78756
      • Heart Hospital of Austin
    • Dallas, Texas, United States, 75226
      • Baylor Heart & Vascular Hospital
    • Houston, Texas, United States, 77030
      • St. Luke's Episcopal Hospital
    • San Antonio, Texas, United States, 78201
      • Methodist Texsan Hospital
    • Tyler, Texas, United States, 75701
      • Trinity Mother Frances Health System
  • Virginia
    • Lynchburg, Virginia, United States, 24501
      • Lynchburg General Hospital
    • Norfolk, Virginia, United States, 23507
      • Sentara Norfolk General Hospital
  • Washington
    • Seattle, Washington, United States, 98122
      • Swedish Medical Center
    • Spokane, Washington, United States, 99204
      • Deaconess Medical Center
    • Spokane, Washington, United States, 99204
      • Providence Health & Services - Washington
  • Wisconsin
    • Wausau, Wisconsin, United States, 54401
      • Aspirus Heart and Vascular Institute - Research and Education

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patient must be at least 18 years of age
• Patient (or legal guardian) understands study requirements and treatment procedures and provides written informed consent before any study-specific tests or procedures are performed
• For patients less than 20 years of age enrolled at a Japanese site, patient and patient's legal representative must provide written informed consent before any study-specific tests or procedures are performed
• Patient is eligible for percutaneous coronary intervention (PCI)
• Patient has documented stable angina pectoris or documented silent ischemia; or unstable angina pectoris
• Patient is an acceptable candidate for coronary artery bypass grafting (CABG)
• Patient has a left ventricular ejection fraction (LVEF) >=30% as measured within 30 days prior to enrollment
• Patient is willing to comply with all protocol-required follow-up evaluations

Angiographic Inclusion Criteria (visual estimate):

- Target lesion must be a de novo lesion located in a native coronary artery with a visually estimated reference vessel diameter (RVD) >=2.50 mm and <=4.25 mm. Target lesion length must measure (by visual estimate) <=24 mm. Target lesion must be in a major coronary artery or branch with visually estimated stenosis >=50% and <100% with Thrombolysis in Myocardial Infarction (TIMI) flow >1.

Exclusion Criteria:

• Patient has clinical symptoms and/or electrocardiogram (ECG) changes consistent with acute myocardial infarction (MI)

• Patient has had a known diagnosis of recent MI (ie, within 72 hours prior to index procedure) and has elevated enzymes at time of index procedure as follows.

  • Patients are excluded if any of the following criteria are met at time of the index procedure.

    • If creatine kinase-myoglobin band (CK-MB) >2× upper limit of normal (ULN), the patient is excluded regardless of CK Total.
    • If CK-MB is 1-2× ULN, the patient is excluded if the CK Total is >2× ULN.

  • If CK Total/CK MB are not used and Troponin is, patients are excluded if the following criterion is met at time of index procedure.

    • Troponin >1× ULN with at least one of the following.

      • Patient has ischemic symptoms and ECG changes indicative of ongoing ischemia (eg, >1 mm ST segment elevation or depression in consecutive leads or new left bundle branch block [LBBB]);
      • Development of pathological Q waves in the ECG; or
      • Imaging evidence of new loss of viable myocardium or new regional wall motion abnormality.

Note: For patients with unstable angina or patients who have had a recent MI, CK Total/CK MB (or Troponin if CK Total/CK MB are not used) must be documented prior to enrolling/randomizing the patient.

• Patient has received an organ transplant or is on a waiting list for an organ transplant
• Patient is receiving or scheduled to receive chemotherapy within 30 days before or after index procedure
• Patient is receiving oral or intravenous immunosuppressive therapy (ie, inhaled steroids are not excluded) or has known life-limiting immunosuppressive or autoimmune disease (eg, human immunodeficiency virus, systemic lupus erythematosus, but not including diabetes mellitus)
• Patient is receiving chronic (>=72 hours) anticoagulation therapy (eg, heparin, coumadin) for indications other than acute coronary syndrome
• Patient has platelet count <100,000 cells/mm3 or >700,000 cells/mm3
• Patient has white blood cell (WBC) count <3,000 cells/mm3
• Patient has documented or suspected liver disease, including laboratory evidence of hepatitis
• Patient is on dialysis or has known renal insufficiency (ie, estimated creatinine clearance <50 ml/min by the Cockcroft Gault formula, or [(140-age)*lean body weight (in kg)]/[plasma creatinine (mg/dl)*72])
• Patient has history of bleeding diathesis or coagulopathy or will refuse blood transfusions
• Patient has had a cerebrovascular accident (CVA) or transient ischemic attack (TIA) within past 6 months, or has any permanent neurologic defect that may cause non-compliance with the protocol
• Target vessel(s) or side branch has been treated with any type of PCI (eg, balloon angioplasty, stent, cutting balloon, atherectomy) within 12 months prior to index procedure
• Target vessel(s) has been treated within 10 mm proximal or distal to target lesion (by visual estimate) with any type of PCI (eg, balloon angioplasty, stent, cutting balloon, atherectomy) at any time prior to index procedure
• Non-target vessel or side branch has been treated with any type of PCI (eg, balloon angioplasty, stent, cutting balloon, atherectomy) within 24 hours prior to index procedure
• Planned or actual target vessel(s) treatment with an unapproved device, directional or rotational coronary atherectomy, laser, cutting balloon, or transluminal extraction catheter immediately prior to stent placement
• Planned PCI or CABG after index procedure
• Patient previously treated at any time with coronary intravascular brachytherapy
• Patient has a known allergy to the study stent system or protocol-required concomitant medications (eg, stainless steel, platinum, cobalt, chromium, nickel, tungsten, acrylic, fluoropolymers, everolimus, thienopyridines, aspirin, contrast) that cannot be adequately premedicated
• Patient has active peptic ulcer or active gastrointestinal (GI) bleeding

• Patient has one of the following.

  • Other serious medical illness (eg, cancer, congestive heart failure) that may reduce life expectancy to less than 24 months
  • Current problems with substance abuse (eg, alcohol, cocaine, heroin, etc.)
  • Planned procedure that may cause non-compliance with protocol or confound data interpretation
• Patient is participating in another investigational drug or device clinical trial that has not reached its primary endpoint
• Patient intends to participate in another investigational drug or device clinical trial within 12 months after index procedure
• Patient with known intention to procreate within 12 months after index procedure (Women of child-bearing potential who are sexually active must agree to use a reliable method of contraception from the time of screening through 12 months after the index procedure.)
• Patient is a woman who is pregnant or nursing (A pregnancy test must be performed within 7 days prior to the index procedure in women of child-bearing potential)
• Patient has more than 2 target lesions, or more than 1 target lesion and 1 non-target lesion, which will be treated during the index procedure

Angiographic Exclusion Criteria (visual estimate):

• Target lesion meets any of the following criteria:

  • Aorto-ostial location (ie, lesion located within 5 mm of ostium by visual estimate)
  • Left main location
  • Located within 5 mm of origin of the left anterior descending (LAD) coronary artery or left circumflex (LCX) coronary artery by visual estimate
  • Located within a saphenous vein graft or arterial graft
  • Will be accessed via a saphenous vein graft or arterial graft
  • Involves a side branch >=2.0 mm in diameter by visual estimate
  • Involves a clinically significant side branch <2.0 mm in diameter by visual estimate that has a clinically significant stenosis at the ostium
  • TIMI flow 0 (total occlusion) or TIMI flow 1 prior to wire crossing
  • Excessive tortuosity proximal to or within the lesion
  • Extreme angulation proximal to or within the lesion
  • Target lesion and/or target vessel proximal to the target lesion is moderately to severely calcified by visual estimate
  • Restenotic from previous intervention
  • Thrombus, or possible thrombus, present in target vessel

• Non-target lesion to be treated during the index procedure meets any of the following criteria:

  • Located within the target vessel
  • Located within a bypass graft (venous or arterial)
  • Left main location
  • Chronic total occlusion
  • Involves a complex bifurcation (eg, bifurcations requiring treatment with more than 1 stent)
  • Restenotic from previous intervention
• Patient has unprotected left main coronary artery disease (>50% diameter stenosis)
• Patient has protected left main coronary artery disease and a target lesion in the LAD or LCX
• Patient has an additional clinically significant lesion(s) in target vessel for which an intervention within 12 months after the index procedure is likely to be required
• Patient has 2 target lesions in the same vessel that are separated by less than 15 mm (by visual estimate) Note: Multiple focal stenoses will be considered as a single lesion if they can be completely covered with 1 stent.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: PROMUS; Patients who received the PROMUS (XIENCE V) Everolimus-Eluting Coronary Stent	Drug: Aspirin; Patients are required to take aspirin indefinitely after stent implant. It is recommended that aspirin 162-325 mg daily be given for at least 6 months after stent placement and that aspirin 75-162 mg daily be given indefinitely thereafter.; Drug: Thienopyridine; Patients must be treated with one of the following thienopyridines for at least 6 months following the index procedure: clopidogrel 75 mg daily; or ticlopidine 250 mg twice daily; or prasugrel (outside the United States and if approved at the time of the procedure). If used, the prescribed dose should be in accordance with approved country-specific labeling. In patients not at high risk of bleeding, thienopyridine treatment should continue for at least 12 months after stent implant.; Other Names: A brand name for clopidogrel is PLAVIX.; A brand name for ticlopidine is TICLID.; Device: PROMUS Coronary Stent System; PROMUS is a device/drug combination product composed of two components, a device (coronary stent system including a cobalt chromium stent platform) and a drug product (a formulation of everolimus contained in a polymer coating).; Other Names: XIENCE V
Experimental: PROMUS Element; Patients who received the PROMUS™ Element Everolimus-Eluting Coronary Stent	Drug: Aspirin; Patients are required to take aspirin indefinitely after stent implant. It is recommended that aspirin 162-325 mg daily be given for at least 6 months after stent placement and that aspirin 75-162 mg daily be given indefinitely thereafter.; Drug: Thienopyridine; Patients must be treated with one of the following thienopyridines for at least 6 months following the index procedure: clopidogrel 75 mg daily; or ticlopidine 250 mg twice daily; or prasugrel (outside the United States and if approved at the time of the procedure). If used, the prescribed dose should be in accordance with approved country-specific labeling. In patients not at high risk of bleeding, thienopyridine treatment should continue for at least 12 months after stent implant.; Other Names: A brand name for clopidogrel is PLAVIX.; A brand name for ticlopidine is TICLID.; Device: PROMUS Element Coronary Stent System; PROMUS Element is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a polymer coating that is the same as on the PROMUS [XIENCE V] stent).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Target Lesion Failure (TLF)	Defined as any ischemia-driven revascularization of the target lesion, myocardial infarction (Q-wave and non-Q-wave) related to the target vessel, or cardiac death related to the target vessel.	12-month post index procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
All Cause Mortality		6 months
All Cause Mortality		12 months
Target Vessel Revascularization (TVR)	TVR is any ischemia-driven repeat percutaneous intervention to improve blood flow, or bypass surgery of not previously existing lesions with diameter stenosis ≥50% by quantitative coronary angiography in the target vessel, including the target lesion.	6 months
Target Lesion Revascularization (TLR)	TLR is any ischemia-driven repeat percutaneous intervention to improve blood flow of the successfully treated target lesion or bypass surgery of the target vessel with a graft distally to the successfully treated target lesion.	6 months
Definite + Probable Stent Thrombosis (ST) Rate Based on Academic Research Consortium (ARC) Definition	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
Target Lesion Revascularization (TLR)	TLR is any ischemia-driven repeat percutaneous intervention to improve blood flow of the successfully treated target lesion or bypass surgery of the target vessel with a graft distally to the successfully treated target lesion.	12 months
Target Vessel Revascularization (TVR)	TVR is any ischemia-driven repeat percutaneous intervention to improve blood flow, or bypass surgery of not previously existing lesions with diameter stenosis ≥50% by quantitative coronary angiography in the target vessel, including the target lesion.	12 months
All Cause Mortality		30 days
Target Lesion Failure (TLF)	TLF is defined as any ischemia-driven revascularization of the target lesion, myocardial infarction (Q-wave and non-Q-wave) related to the target vessel, or cardiac death related to the target vessel.	30 days
Target Lesion Failure (TLF)	TLF is defined as any ischemia-driven revascularization of the target lesion, myocardial infarction (Q-wave and non-Q-wave) related to the target vessel, or cardiac death related to the target vessel.	6 months
Target Lesion Failure (TLF)	TLF is defined as any ischemia-driven revascularization of the target lesion, myocardial infarction (Q-wave and non-Q-wave) related to the target vessel, or cardiac death related to the target vessel.	12 months
Target Vessel Failure (TVF)	TVF is defined as any ischemia-driven revascularization of the target vessel, MI (Q-wave and non-Q-wave) 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 the MI or death was related to the target vessel, it will be considered a TVF.	30 days
Target Vessel Failure (TVF)	TVF is defined as any ischemia-driven revascularization of the target vessel, MI (Q-wave and non-Q-wave) 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 the MI or death was related to the target vessel, it will be considered a TVF.	6 months
Target Vessel Failure (TVF)	TVF is defined as any ischemia-driven revascularization of the target vessel, MI (Q-wave and non-Q-wave) 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 the MI or death was related to the target vessel, it will be considered a TVF.	12 months
Myocardial Infarction (MI) Related to the Target Vessel	Development of new Q-waves in ≥2 leads lasting ≥0.04 seconds with CK-MB/troponin levels above normal; if no new Q-waves, total creatine kinase (CK) >3x normal (peri-percutaneous coronary intervention [PCI]) or >2x normal (spontaneous) with elevated CK-MB, or troponin >3x normal (peri-PCI) or >2x normal (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 criteria for MI post bypass graft surgery, with CK-MB or troponin >5x normal	30 days
Myocardial Infarction (MI) Related to the Target Vessel	Development of new Q-waves in ≥2 leads lasting ≥0.04 seconds with CK-MB/troponin levels above normal; if no new Q-waves, total creatine kinase (CK) >3x normal (peri-percutaneous coronary intervention [PCI]) or >2x normal (spontaneous) with elevated CK-MB, or troponin >3x normal (peri-PCI) or >2x normal (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 criteria for MI post bypass graft surgery, with CK-MB or troponin >5x normal	6 months
Myocardial Infarction (MI) Related to the Target Vessel	Development of new Q-waves in ≥2 leads lasting ≥0.04 seconds with CK-MB/troponin levels above normal; if no new Q-waves, total creatine kinase (CK) >3x normal (peri-percutaneous coronary intervention [PCI]) or >2x normal (spontaneous) with elevated CK-MB, or troponin >3x normal (peri-PCI) or >2x normal (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 criteria for MI post bypass graft surgery, with CK-MB or troponin >5x normal	12 months
Cardiac Death Related to the Target Vessel	Cardiac death is defined as Death due to any of the following: acute myocardial infarction (MI); cardiac perforation/pericardial tamponade; arrhythmia or conduction abnormality; cerebrovascular accident (CVA) through hospital discharge or CVA suspected of being related to the procedure; complication of the procedure including bleeding, vascular repair, transfusion reaction, or bypass surgery or any death in which a cardiac cause cannot be excluded	30 days
Cardiac Death Related to the Target Vessel	Cardiac death is defined as Death due to any of the following: acute myocardial infarction (MI); cardiac perforation/pericardial tamponade; arrhythmia or conduction abnormality; cerebrovascular accident (CVA) through hospital discharge or CVA suspected of being related to the procedure; complication of the procedure including bleeding, vascular repair, transfusion reaction, or bypass surgery or any death in which a cardiac cause cannot be excluded	6 months
Cardiac Death Related to the Target Vessel	Cardiac death is defined as Death due to any of the following: acute myocardial infarction (MI); cardiac perforation/pericardial tamponade; arrhythmia or conduction abnormality; cerebrovascular accident (CVA) through hospital discharge or CVA suspected of being related to the procedure; complication of the procedure including bleeding, vascular repair, transfusion reaction, or bypass surgery or any death in which a cardiac cause cannot be excluded	12 months
Non-cardiac Death	Defined as a death not due to cardiac causes (see definition of cardiac death above)	30 Days
Non-cardiac Death	Defined as a death not due to cardiac causes (see definition of cardiac death above)	6 Months
Non-cardiac Death	Defined as a death not due to cardiac causes (see definition of cardiac death above)	12 months
Cardiac Death or Myocardial Infarction (MI)	Cardiac death is defined as death due to any of the following: acute myocardial infarction (MI); cardiac perforation/pericardial tamponade; arrhythmia or conduction abnormality; cerebrovascular accident (CVA) through hospital discharge or CVA suspected of being related to the procedure; complication of the procedure including bleeding, vascular repair, transfusion reaction, or bypass surgery or any death in which a cardiac cause cannot be excluded; see definition of MI above	30 days
Cardiac Death or Myocardial Infarction (MI)	Cardiac death is defined as death due to any of the following: acute myocardial infarction (MI); cardiac perforation/pericardial tamponade; arrhythmia or conduction abnormality; cerebrovascular accident (CVA) through hospital discharge or CVA suspected of being related to the procedure; complication of the procedure including bleeding, vascular repair, transfusion reaction, or bypass surgery or any death in which a cardiac cause cannot be excluded; see definition of MI above	6 months
Cardiac Death or Myocardial Infarction (MI)	Cardiac death is defined as Death due to any of the following: acute myocardial infarction (MI); cardiac perforation/pericardial tamponade; arrhythmia or conduction abnormality; cerebrovascular accident (CVA) through hospital discharge or CVA suspected of being related to the procedure; complication of the procedure including bleeding, vascular repair, transfusion reaction, or bypass surgery or any death in which a cardiac cause cannot be excluded; see definition of MI above	12 months
All Death or Myocardial Infarction (MI)	Development of new Q-waves in ≥2 leads lasting ≥0.04 seconds with CK-MB/troponin levels above normal; if no new Q-waves, total creatine kinase (CK) >3x normal (peri-percutaneous coronary intervention [PCI]) or >2x normal (spontaneous) with elevated CK-MB, or troponin >3x normal (peri-PCI) or >2x normal (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 criteria for MI post bypass graft surgery, with CK-MB or troponin >5x normal	30 days
All Death or Myocardial Infarction (MI)	Development of new Q-waves in ≥2 leads lasting ≥0.04 seconds with CK-MB/troponin levels above normal; if no new Q-waves, total creatine kinase (CK) >3x normal (peri-percutaneous coronary intervention [PCI]) or >2x normal (spontaneous) with elevated CK-MB, or troponin >3x normal (peri-PCI) or >2x normal (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 criteria for MI post bypass graft surgery, with CK-MB or troponin >5x normal	6 months
All Death or Myocardial Infarction (MI)	Development of new Q-waves in ≥2 leads lasting ≥0.04 seconds with CK-MB/troponin levels above normal; if no new Q-waves, total creatine kinase (CK) >3x normal (peri-percutaneous coronary intervention [PCI]) or >2x normal (spontaneous) with elevated CK-MB, or troponin >3x normal (peri-PCI) or >2x normal (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 criteria for MI post bypass graft surgery, with CK-MB or troponin >5x normal	12 months
Target Lesion Revascularization (TLR)	Target lesion revascularization is any ischemia-driven repeat percutaneous intervention to improve blood flow of the successfully treated target lesion or bypass surgery of the target vessel with a graft distally to the successfully treated target lesion.	30 days
Target Vessel Revascularization (TVR)	Target vessel revascularization is any ischemia-driven repeat percutaneous intervention to improve blood flow, or bypass surgery of not previously existing lesions with diameter stenosis ≥50% by quantitative coronary angiography in the target vessel, including the target lesion.	30 days
Definite + Probable Stent Thrombosis (ST) Rate Based on Academic Research Consortium (ARC) Definition	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 hr-30 days
Definite + Probable Stent Thrombosis (ST) Rate Based on Academic Research Consortium (ARC) Definition	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).	>30 days-1 year
Composite of All Death, All Myocardial Infarction (MI), All Target Vessel Revascularization (TVR)	See above for definitions of MI and TVR	30 days
Composite of All Death, All Myocardial Infarction (MI), All Target Vessel Revascularization (TVR)	See above for definitions of MI and TVR.	6 months
Composite of All Death, All Myocardial Infarction (MI), All Target Vessel Revascularization (TVR)	See above for definitions of MI and TVR.	12 months
Clinical Procedural Success	Defined as mean lesion diameter stenosis <30% with visually assessed TIMI 3 flow and without the occurrence of in-hospital myocardial infarction (MI), target vessel revascularization (TVR), or cardiac death	In hospital
Acute Technical Success	Defined as successful delivery and deployment of the study stent to the target vessel, without balloon rupture or stent embolization; expressed per stent	Acute-At time of index procedure

Collaborators and Investigators

• Sponsor: Boston Scientific Corporation

Publications and helpful links

General Publications

• Stone GW, Teirstein PS, Meredith IT, Farah B, Dubois CL, Feldman RL, Dens J, Hagiwara N, Allocco DJ, Dawkins KD; PLATINUM Trial Investigators. A prospective, randomized evaluation of a novel everolimus-eluting coronary stent: the PLATINUM (a Prospective, Randomized, Multicenter Trial to Assess an Everolimus-Eluting Coronary Stent System [PROMUS Element] for the Treatment of Up to Two de Novo Coronary Artery Lesions) trial. J Am Coll Cardiol. 2011 Apr 19;57(16):1700-8. doi: 10.1016/j.jacc.2011.02.016. Epub 2011 Apr 4.
• Kelly CR, Teirstein PS, Meredith IT, Farah B, Dubois CL, Feldman RL, Dens J, Hagiwara N, Rabinowitz A, Carrie D, Pompili V, Bouchard A, Saito S, Allocco DJ, Dawkins KD, Stone GW. Long-Term Safety and Efficacy of Platinum Chromium Everolimus-Eluting Stents in Coronary Artery Disease: 5-Year Results From the PLATINUM Trial. JACC Cardiovasc Interv. 2017 Dec 11;10(23):2392-2400. doi: 10.1016/j.jcin.2017.06.070.

Study record dates

Study Major Dates

• Study Start: January 1, 2009
• Primary Completion (Actual): September 1, 2010
• Study Completion (Actual): December 1, 2014

Study Registration Dates

• First Submitted: January 13, 2009
• First Submitted That Met QC Criteria: January 13, 2009
• First Posted (Estimate): January 15, 2009

Study Record Updates

• Last Update Posted (Actual): March 27, 2019
• Last Update Submitted That Met QC Criteria: March 13, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Keywords: atherosclerotic; DES; drug-eluting stents
• 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; 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; Cytochrome P-450 Enzyme Inhibitors; Cytochrome P-450 CYP2C19 Inhibitors; Aspirin; Clopidogrel; Ticlopidine
• Other Study ID Numbers: S2046; ACTRN12608000582358

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: The data and study protocol for this clinical trial may be made available to other researchers in accordance with the Boston Scientific Data Sharing Policy (http://www.bostonscientific.com/en-US/data-sharing-requests.html).