Clinical trial NCT00823212: The PLATINUM Clinical Trial to Assess the PROMUS Element Stent System for Treatment of De Novo Coronary Artery Lesions
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Coronary Artery Disease
Keywords: drug-eluting stents
DES
atherosclerotic
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2009-01-15
Enrollment: 1530
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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).

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 The study design is consistent with the draft guidance for industry titled, "Coronary Drug-Eluting Stents - Nonclinical and Clinical Studies" (March 2008).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.

Eligibility criteria: 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.

Primary outcomes:
measure: Target Lesion Failure (TLF)
timeFrame: 12-month post index procedure
Secondary outcomes:
measure: Target Lesion Failure (TLF)
timeFrame: 30 days
measure: Target Lesion Failure (TLF)
timeFrame: 6 months
measure: Target Lesion Failure (TLF)
timeFrame: 12 months
measure: Target Vessel Failure (TVF)
timeFrame: 30 days
measure: Target Vessel Failure (TVF)
timeFrame: 6 months
measure: Target Vessel Failure (TVF)
timeFrame: 12 months
measure: Myocardial Infarction (MI) Related to the Target Vessel
timeFrame: 30 days
measure: Myocardial Infarction (MI) Related to the Target Vessel
timeFrame: 6 months
measure: Myocardial Infarction (MI) Related to the Target Vessel
timeFrame: 12 months
measure: All Cause Mortality
timeFrame: 30 days
measure: All Cause Mortality
timeFrame: 6 months
measure: All Cause Mortality
timeFrame: 12 months
measure: Cardiac Death Related to the Target Vessel
timeFrame: 30 days
measure: Cardiac Death Related to the Target Vessel
timeFrame: 6 months
measure: Cardiac Death Related to the Target Vessel
timeFrame: 12 months
measure: Non-cardiac Death
timeFrame: 30 Days
measure: Non-cardiac Death
timeFrame: 6 Months
measure: Non-cardiac Death
timeFrame: 12 months
measure: Cardiac Death or Myocardial Infarction (MI)
timeFrame: 30 days
measure: Cardiac Death or Myocardial Infarction (MI)
timeFrame: 6 months
measure: Cardiac Death or Myocardial Infarction (MI)
timeFrame: 12 months
measure: All Death or Myocardial Infarction (MI)
timeFrame: 30 days
measure: All Death or Myocardial Infarction (MI)
timeFrame: 6 months
measure: All Death or Myocardial Infarction (MI)
timeFrame: 12 months
measure: Target Lesion Revascularization (TLR)
timeFrame: 30 days
measure: Target Lesion Revascularization (TLR)
timeFrame: 6 months
measure: Target Lesion Revascularization (TLR)
timeFrame: 12 months
measure: Target Vessel Revascularization (TVR)
timeFrame: 30 days
measure: Target Vessel Revascularization (TVR)
timeFrame: 6 months
measure: Target Vessel Revascularization (TVR)
timeFrame: 12 months
measure: Definite + Probable Stent Thrombosis (ST) Rate Based on Academic Research Consortium (ARC) Definition
timeFrame: 24 hours
measure: Definite + Probable Stent Thrombosis (ST) Rate Based on Academic Research Consortium (ARC) Definition
timeFrame: >24 hr-30 days
measure: Definite + Probable Stent Thrombosis (ST) Rate Based on Academic Research Consortium (ARC) Definition
timeFrame: >30 days-1 year
measure: Composite of All Death, All Myocardial Infarction (MI), All Target Vessel Revascularization (TVR)
timeFrame: 30 days
measure: Composite of All Death, All Myocardial Infarction (MI), All Target Vessel Revascularization (TVR)
timeFrame: 6 months
measure: Composite of All Death, All Myocardial Infarction (MI), All Target Vessel Revascularization (TVR)
timeFrame: 12 months
measure: Clinical Procedural Success
timeFrame: In hospital
measure: Acute Technical Success
timeFrame: Acute-At time of index procedure
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Baptist Medical Center Princeton
state: Alabama
city: Phoenix
country: United States
facility: Banner Good Samaritan Regional Medical Center
state: Arizona
city: Little Rock
country: United States
facility: Arkansas Heart Hospital
state: Arkansas
city: Bakersfield
country: United States
facility: Bakersfield Memorial Hospital
state: California
city: La Jolla
country: United States
facility: Scripps Clinic
state: California
city: Los Angeles
country: United States
facility: Good Samaritan Hospital
state: California
city: Sacramento
country: United States
facility: University of California Davis Medical Center
state: California
city: Sacramento
country: United States
facility: Mercy General Hospital
state: California
city: San Diego
country: United States
facility: University of California San Diego
state: California
city: San Diego
country: United States
facility: Alvarado Hospital
state: California
city: Littleton
country: United States
facility: South Denver Cardiology Associates, PC
state: Colorado
city: Loveland
country: United States
facility: Medical Center of the Rockies (Loveland)
state: Colorado
city: Fort Lauderdale
country: United States
facility: Holy Cross Hospital
state: Florida
city: Ocala
country: United States
facility: MediQuest Research Group Inc. at Munroe Regional Medical Center
state: Florida
city: Orlando
country: United States
facility: Florida Hospital
state: Florida
city: Tallahassee
country: United States
facility: Tallahassee Memorial Hospital
state: Florida
city: Macon
country: United States
facility: Medical Center of Central Georgia
state: Georgia
city: Springfield
country: United States
facility: Southern Illinois University Memorial Medical Center
state: Illinois
city: Springfield
country: United States
facility: St. John's Hospital
state: Illinois
city: Indianapolis
country: United States
facility: Krannert Institute of Cardiology
state: Indiana
city: Indianapolis
country: United States
facility: St. Vincent's Hospital
state: Indiana
city: Des Moines
country: United States
facility: Mercy Hospital Medical Center
state: Iowa
city: Louisville
country: United States
facility: Jewish Hospital and St. Mary's Healthcare
state: Kentucky
city: Portland
country: United States
facility: Maine Medical Center
state: Maine
city: Baltimore
country: United States
facility: Union Memorial Hospital
state: Maryland
city: Takoma Park
country: United States
facility: Washington Adventist Hospital
state: Maryland
city: Boston
country: United States
facility: Tufts Medical Center
state: Massachusetts
city: Springfield
country: United States
facility: Baystate Medical Center
state: Massachusetts
city: Grand Blanc
country: United States
facility: Genesys Regional Medical Center
state: Michigan
city: Grand Rapids
country: United States
facility: Spectrum Health Hospitals
state: Michigan
city: Petoskey
country: United States
facility: Northern Michigan Hospital
state: Michigan
city: Royal Oak
country: United States
facility: William Beaumont Hospital
state: Michigan
city: Duluth
country: United States
facility: St. Mary's Duluth Clinic Regional Heart Center
state: Minnesota
city: Minneapolis
country: United States
facility: Abbott Northwestern Hospital
state: Minnesota
city: Rochester
country: United States
facility: Mayo Clinic Foundation
state: Minnesota
city: Tupelo
country: United States
facility: North Mississippi Medical Center
state: Mississippi
city: Kansas City
country: United States
facility: St. Luke's Hospital / Mid America Heart Institute
state: Missouri
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Saint Louis
country: United States
facility: Missouri Baptist Medical Center
state: Missouri
city: Lincoln
country: United States
facility: Nebraska Heart Institute
state: Nebraska
city: Camden
country: United States
facility: Cooper Hospital/University Medical Center
state: New Jersey
city: Camden
country: United States
facility: Our Lady of Lourdes Medical Center
state: New Jersey
city: Brooklyn
country: United States
facility: Maimonides Medical Center
state: New York
city: Buffalo
country: United States
facility: Kaleida Health
state: New York
city: New York
country: United States
facility: Mount Sinai School Medical Center
state: New York
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
city: Roslyn
country: United States
facility: St. Francis Hospital
state: New York
city: Greensboro
country: United States
facility: Moses H. Cone Memorial Hospital/LeBauer Cardiovascular Research Foundation
state: North Carolina
city: Raleigh
country: United States
facility: Wake Medical Center
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest University School of Medicine
state: North Carolina
city: Cincinnati
country: United States
facility: Lindner Center for Research and Education at The Christ Hospital
state: Ohio
city: Cincinnati
country: United States
facility: Good Samaritan Hospital
state: Ohio
city: Columbus
country: United States
facility: Ohio State University Medical Center
state: Ohio
city: Columbus
country: United States
facility: Ohio Health Research and Innovation Institute
state: Ohio
city: Sandusky
country: United States
facility: Firelands Regional Medical Center
state: Ohio
city: Toledo
country: United States
facility: Mercy St. Vincent Medical Center
state: Ohio
city: Oklahoma City
country: United States
facility: Oklahoma Heart Hospital
state: Oklahoma
city: Portland
country: United States
facility: Providence St. Vincent Medical Center
state: Oregon
city: Bryn Mawr
country: United States
facility: Lankenau Institute for Medical Research
state: Pennsylvania
city: Harrisburg
country: United States
facility: Pinnacle Health at Harrisburg Hospital
state: Pennsylvania
city: Hershey
country: United States
facility: Penn State Milton S Hershey Medical Center
state: Pennsylvania
city: Columbia
country: United States
facility: Sisters of Charity Providence Hospital
state: South Carolina
city: Jackson
country: United States
facility: Jackson-Madison County General Hospital
state: Tennessee
city: Memphis
country: United States
facility: Baptist Memorial Hospital
state: Tennessee
city: Austin
country: United States
facility: Heart Hospital of Austin
state: Texas
city: Dallas
country: United States
facility: Baylor Heart & Vascular Hospital
state: Texas
city: Houston
country: United States
facility: St. Luke's Episcopal Hospital
state: Texas
city: San Antonio
country: United States
facility: Methodist Texsan Hospital
state: Texas
city: Tyler
country: United States
facility: Trinity Mother Frances Health System
state: Texas
city: Lynchburg
country: United States
facility: Lynchburg General Hospital
state: Virginia
city: Norfolk
country: United States
facility: Sentara Norfolk General Hospital
state: Virginia
city: Seattle
country: United States
facility: Swedish Medical Center
state: Washington
city: Spokane
country: United States
facility: Deaconess Medical Center
state: Washington
city: Spokane
country: United States
facility: Providence Health & Services - Washington
state: Washington
city: Wausau
country: United States
facility: Aspirus Heart and Vascular Institute - Research and Education
state: Wisconsin
city: Clayton
country: Australia
facility: Monash Medical Centre
state: Victoria
city: Fitzroy
country: Australia
facility: St. Vincent's Hospital
state: Victoria
city: Perth
country: Australia
facility: Royal Perth Hospital
city: Queensland
country: Australia
facility: The Prince Charles Hospital
city: Vienna
country: Austria
facility: Allgemeines Krankenhauas AKH
city: Antwerpen
country: Belgium
facility: Academisch Ziekenhuis Middelheim
city: Genk
country: Belgium
facility: Ziekenhuis Oost Limburg
city: Gent
country: Belgium
facility: Universitair Ziekenhuis Gent
city: Leuven
country: Belgium
facility: UZ Gasthuisberg
city: Aarhus
country: Denmark
facility: Skejby Sygehus
city: Copenhagen
country: Denmark
facility: Rigshospitalet Copenhagen
city: Oulu
country: Finland
facility: Oulu University Hospital
city: Tampere
country: Finland
facility: Tampere University Hospital
city: Turku
country: Finland
facility: Turku University Hospital
city: Besancon
country: France
facility: CHU de Besancon
city: Bordeaux
country: France
facility: Clinique St. Augustin
city: Massy
country: France
facility: Institut Cardiovasculaire - Paris Sud / Institut Hospitalier Jacques Cartier
city: Montpellier
country: France
facility: Clinique du Millenaire
city: Toulouse
country: France
facility: Centre Hopital Universitaire Rangueil
city: Toulouse
country: France
facility: Clinique Pasteur
city: Bad Nauheim
country: Germany
facility: Kerckhoff Klinik
city: Bad Oeynhausen
country: Germany
facility: Herz-und Diabeteszentrum Nordrhein-Westfalen
city: Bad Segeberg
country: Germany
facility: Herz-Kreislauf-Zentrum Segeberger Kliniken GmbH
city: Berlin
country: Germany
facility: Universitatsklinik Charite Berlin
city: Heidelberg
country: Germany
facility: Universitat Heidelberg
city: Leipzig
country: Germany
facility: Herzzentrum Universitat Leipzig
city: Kitakyushu-shi
country: Japan
facility: Kokura Memorial Hospital
state: Fukuoka
city: Sapporo-shi
country: Japan
facility: Japan Community Health Care Organization Hokkaido Hospital
state: Hokkaido
city: Kamakura-shi
country: Japan
facility: Shonan Kamakura General Hospital
state: Kanagawa
city: Yokohama-shi
country: Japan
facility: Saiseikai Yokohama-City Eastern Hospital
state: Kanagawa
city: Fuchu-shi
country: Japan
facility: Sakakibara Heart Institute, Japan Research Promotion Society for Cardiovascular Diseases
state: Tokyo
city: Itabashi-ku
country: Japan
facility: Teikyo University Hospital
state: Tokyo
city: Meguro-ku
country: Japan
facility: Toho University Ohashi Medical Center
state: Tokyo
city: Minato-ku
country: Japan
facility: The Cardiovascular Institute Hospital
state: Tokyo
city: Shinjuku-ku
country: Japan
facility: Tokyo Women's Medical University Hospital
state: Tokyo
city: Osaka
country: Japan
facility: Sakurabashi Watanabe Hospital
city: Riga
country: Latvia
facility: P. Stradins University Hospital
city: Kota Samarahan
country: Malaysia
facility: Sarawak General Hospital
state: Sarawak
city: Kuala Lumpur
country: Malaysia
facility: Institut Jantung Negara
city: Alkmaar
country: Netherlands
facility: Medisch Centrum Alkmaar
city: Breda
country: Netherlands
facility: Amphia Ziekenhuis
city: Eindhoven
country: Netherlands
facility: Catherina Ziekenhuis
city: Nieuwegein
country: Netherlands
facility: St Antonius Ziekenhuis
city: Otahuhu
country: New Zealand
facility: Middlemore Hospital
state: Auckland
city: Auckland
country: New Zealand
facility: Ascot Angiography
city: Wellington
country: New Zealand
facility: Wellington Hospital
city: Bydgoszcz
country: Poland
facility: Szpital Uniwersytecki
city: Krakow
country: Poland
facility: SPZOZ Szpital Uniwersytecki w Krakowie
city: Warsaw
country: Poland
facility: National Institute of Cardiology
city: Wroklaw
country: Poland
facility: Military Hospital
city: Carnaxide
country: Portugal
facility: Hospital De Santa Cruz
city: Singapore
country: Singapore
facility: National Heart Centre Singapore
city: London
country: United Kingdom
facility: Guys and St. Thomas NHS Foundation Trust St. Thomas Hospital
state: England
city: Middlesbrough
country: United Kingdom
facility: James Cook University Hospital
state: England
city: Oxford
country: United Kingdom
facility: John Radcliffe Infirmary Oxford II
state: England
city: Belfast
country: United Kingdom
facility: Royal Victoria Hospital
state: Ireland
city: Clydebank
country: United Kingdom
facility: Golden Jubilee National Hospital
city: Southampton
country: United Kingdom
facility: Southampton University Hospital
Study officials:
affiliation: Boston Scientific Corporation
name: Peter M Maurer, MPH
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.