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

NCT00823212 | Completed Phase 3 Results DMC

• 2 other identifiers: S2046ACTRN12608000582358
• Study Type: interventional
• Target: 1,530
• Locations: 16 countries
• Sites: 132

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).

Conditions

Coronary Artery Disease

Keywords

drug-eluting stents; DES; atherosclerotic

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (38)

• Target Lesion Failure (TLF)

  30 days

• Target Lesion Failure (TLF)

  6 months

• Target Lesion Failure (TLF)

  12 months

• Target Vessel Failure (TVF)

  30 days

• Target Vessel Failure (TVF)

  6 months

Study Arms (2)

PROMUS

ACTIVE COMPARATOR

Patients who received the PROMUS (XIENCE V) Everolimus-Eluting Coronary Stent

Device: PROMUS Coronary Stent System; Drug: Aspirin; Drug: Thienopyridine

PROMUS Element

EXPERIMENTAL

Patients who received the PROMUS™ Element Everolimus-Eluting Coronary Stent

Device: PROMUS Element Coronary Stent System; Drug: Aspirin; Drug: Thienopyridine

Interventions

PROMUS Coronary Stent System DEVICE

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).

Also known as: XIENCE V

PROMUS

PROMUS Element Coronary Stent System DEVICE

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).

PROMUS Element

Aspirin DRUG

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.

PROMUS; PROMUS Element

Thienopyridine DRUG

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.

Also known as: A brand name for clopidogrel is PLAVIX., A brand name for ticlopidine is TICLID.

PROMUS; PROMUS Element

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• \- 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Boston Scientific Corporation: lead

Study Sites (133)

Baptist Medical Center Princeton

Birmingham, Alabama, 35211, United States

Location

Banner Good Samaritan Regional Medical Center

Phoenix, Arizona, 85006, United States

Location

Arkansas Heart Hospital

Little Rock, Arkansas, 72211, United States

Location

Bakersfield Memorial Hospital

Bakersfield, California, 93301, United States

Location

Scripps Clinic

La Jolla, California, 92037, United States

Location

Good Samaritan Hospital

Los Angeles, California, 90017, United States

Location

University of California Davis Medical Center

Sacramento, California, 95817, United States

Location

Mercy General Hospital

Sacramento, California, 95819, United States

Location

University of California San Diego

San Diego, California, 92103, United States

Location

Alvarado Hospital

San Diego, California, 92120, United States

Location

South Denver Cardiology Associates, PC

Littleton, Colorado, 80120, United States

Location

Medical Center of the Rockies (Loveland)

Loveland, Colorado, 80538, United States

Location

Holy Cross Hospital

Fort Lauderdale, Florida, 33308, United States

Location

MediQuest Research Group Inc. at Munroe Regional Medical Center

Ocala, Florida, 34471, United States

Location

Florida Hospital

Orlando, Florida, 32803, United States

Location

Tallahassee Memorial Hospital

Tallahassee, Florida, 32308, United States

Location

Medical Center of Central Georgia

Macon, Georgia, 31201, United States

Location

Southern Illinois University Memorial Medical Center

Springfield, Illinois, 62702, United States

Location

St. John's Hospital

Springfield, Illinois, 62769, United States

Location

Krannert Institute of Cardiology

Indianapolis, Indiana, 46202, United States

Location

St. Vincent's Hospital

Indianapolis, Indiana, 46260, United States

Location

Mercy Hospital Medical Center

Des Moines, Iowa, 50314, United States

Location

Jewish Hospital and St. Mary's Healthcare

Louisville, Kentucky, 40202, United States

Location

Maine Medical Center

Portland, Maine, 04102, United States

Location

Union Memorial Hospital

Baltimore, Maryland, 21218, United States

Location

Washington Adventist Hospital

Takoma Park, Maryland, 20912, United States

Location

Tufts Medical Center

Boston, Massachusetts, 02111, United States

Location

Baystate Medical Center

Springfield, Massachusetts, 01199, United States

Location

Genesys Regional Medical Center

Grand Blanc, Michigan, 48439, United States

Location

Spectrum Health Hospitals

Grand Rapids, Michigan, 49503, United States

Location

Northern Michigan Hospital

Petoskey, Michigan, 49770, United States

Location

William Beaumont Hospital

Royal Oak, Michigan, 48073, United States

Location

St. Mary's Duluth Clinic Regional Heart Center

Duluth, Minnesota, 55805, United States

Location

Abbott Northwestern Hospital

Minneapolis, Minnesota, 55407, United States

Location

Mayo Clinic Foundation

Rochester, Minnesota, 55905, United States

Location

North Mississippi Medical Center

Tupelo, Mississippi, 38801, United States

Location

St. Luke's Hospital / Mid America Heart Institute

Kansas City, Missouri, 64111, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Missouri Baptist Medical Center

St Louis, Missouri, 63131, United States

Location

Nebraska Heart Institute

Lincoln, Nebraska, 68526, United States

Location

Cooper Hospital/University Medical Center

Camden, New Jersey, 08103, United States

Location

Our Lady of Lourdes Medical Center

Camden, New Jersey, 08103, United States

Location

Maimonides Medical Center

Brooklyn, New York, 11219, United States

Location

Kaleida Health

Buffalo, New York, 14209, United States

Location

Mount Sinai School Medical Center

New York, New York, 10029, United States

Location

Columbia University Medical Center

New York, New York, 10032, United States

Location

St. Francis Hospital

Roslyn, New York, 11576, United States

Location

Moses H. Cone Memorial Hospital/LeBauer Cardiovascular Research Foundation

Greensboro, North Carolina, 27401, United States

Location

Wake Medical Center

Raleigh, North Carolina, 27610, United States

Location

Wake Forest University School of Medicine

Winston-Salem, North Carolina, 27157, United States

Location

Lindner Center for Research and Education at The Christ Hospital

Cincinnati, Ohio, 45219, United States

Location

Good Samaritan Hospital

Cincinnati, Ohio, 45220, United States

Location

Ohio State University Medical Center

Columbus, Ohio, 43210, United States

Location

Ohio Health Research and Innovation Institute

Columbus, Ohio, 43214, United States

Location

Firelands Regional Medical Center

Sandusky, Ohio, 44870, United States

Location

Mercy St. Vincent Medical Center

Toledo, Ohio, 43608, United States

Location

Oklahoma Heart Hospital

Oklahoma City, Oklahoma, 73120, United States

Location

Providence St. Vincent Medical Center

Portland, Oregon, 97225, United States

Location

Lankenau Institute for Medical Research

Bryn Mawr, Pennsylvania, 19010, United States

Location

Pinnacle Health at Harrisburg Hospital

Harrisburg, Pennsylvania, 17105, United States

Location

Penn State Milton S Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

Sisters of Charity Providence Hospital

Columbia, South Carolina, 29204, United States

Location

Jackson-Madison County General Hospital

Jackson, Tennessee, 38301, United States

Location

Baptist Memorial Hospital

Memphis, Tennessee, 38120, United States

Location

Heart Hospital of Austin

Austin, Texas, 78756, United States

Location

Baylor Heart & Vascular Hospital

Dallas, Texas, 75226, United States

Location

St. Luke's Episcopal Hospital

Houston, Texas, 77030, United States

Location

Methodist Texsan Hospital

San Antonio, Texas, 78201, United States

Location

Trinity Mother Frances Health System

Tyler, Texas, 75701, United States

Location

Lynchburg General Hospital

Lynchburg, Virginia, 24501, United States

Location

Sentara Norfolk General Hospital

Norfolk, Virginia, 23507, United States

Location

Swedish Medical Center

Seattle, Washington, 98122, United States

Location

Deaconess Medical Center

Spokane, Washington, 99204, United States

Location

Providence Health & Services - Washington

Spokane, Washington, 99204, United States

Location

Aspirus Heart and Vascular Institute - Research and Education

Wausau, Wisconsin, 54401, United States

Location

Monash Medical Centre

Clayton, Victoria, 3168, Australia

Location

St. Vincent's Hospital

Fitzroy, Victoria, 3065, Australia

Location

Royal Perth Hospital

Perth, 6000, Australia

Location

The Prince Charles Hospital

Queensland, 4032, Australia

Location

Allgemeines Krankenhauas AKH

Vienna, A-1090, Austria

Location

Academisch Ziekenhuis Middelheim

Antwerp, B-2020, Belgium

Location

Ziekenhuis Oost Limburg

Genk, 3600, Belgium

Location

Universitair Ziekenhuis Gent

Ghent, B-9000, Belgium

Location

UZ Gasthuisberg

Leuven, B-3000, Belgium

Location

Skejby Sygehus

Aarhus, D-8200, Denmark

Location

Rigshospitalet Copenhagen

Copenhagen, 2100, Denmark

Location

Oulu University Hospital

Oulu, 90029, Finland

Location

Tampere University Hospital

Tampere, 33521, Finland

Location

Turku University Hospital

Turku, 20521, Finland

Location

CHU de Besancon

Besançon, 25030, France

Location

Clinique St. Augustin

Bordeaux, 33000, France

Location

Institut Cardiovasculaire - Paris Sud / Institut Hospitalier Jacques Cartier

Massy, 91300, France

Location

Clinique du Millenaire

Montpellier, 34960, France

Location

Centre Hopital Universitaire Rangueil

Toulouse, 31059, France

Location

Clinique Pasteur

Toulouse, 31076, France

Location

Kerckhoff Klinik

Bad Nauheim, 61231, Germany

Location

Herz-und Diabeteszentrum Nordrhein-Westfalen

Bad Oeynhausen, 32545, Germany

Location

Herz-Kreislauf-Zentrum Segeberger Kliniken GmbH

Bad Segeberg, 23795, Germany

Location

Universitatsklinik Charite Berlin

Berlin, 10117, Germany

Location

Universitat Heidelberg

Heidelberg, 69120, Germany

Location

Herzzentrum Universitat Leipzig

Leipzig, 04289, Germany

Location

Kokura Memorial Hospital

Kitakyushu-shi, Fukuoka, Japan

Location

Japan Community Health Care Organization Hokkaido Hospital

Sapporo, Hokkaido, Japan

Location

Shonan Kamakura General Hospital

Kamakura-shi, Kanagawa, Japan

Location

Saiseikai Yokohama-City Eastern Hospital

Yokohama, Kanagawa, Japan

Location

Sakakibara Heart Institute, Japan Research Promotion Society for Cardiovascular Diseases

Fuchu-shi, Tokyo, Japan

Location

Teikyo University Hospital

Itabashi-ku, Tokyo, Japan

Location

Toho University Ohashi Medical Center

Meguro-ku, Tokyo, Japan

Location

The Cardiovascular Institute Hospital

Minato-ku, Tokyo, Japan

Location

Tokyo Women's Medical University Hospital

Shinjuku-ku, Tokyo, Japan

Location

Sakurabashi Watanabe Hospital

Osaka, 530-0001, Japan

Location

P. Stradins University Hospital

Riga, Latvia

Location

Sarawak General Hospital

Kota Samarahan, Sarawak, 94300, Malaysia

Location

Institut Jantung Negara

Kuala Lumpur, 50400, Malaysia

Location

Medisch Centrum Alkmaar

Alkmaar, 1815 JD, Netherlands

Location

Amphia Ziekenhuis

Breda, 4818CK, Netherlands

Location

Catherina Ziekenhuis

Eindhoven, 5623 EJ, Netherlands

Location

St Antonius Ziekenhuis

Nieuwegein, 3435 CM, Netherlands

Location

Middlemore Hospital

Otahuhu, Auckland, 1640, New Zealand

Location

Ascot Angiography

Auckland, 1051, New Zealand

Location

Wellington Hospital

Wellington, 6021, New Zealand

Location

Szpital Uniwersytecki

Bydgoszcz, 85-094, Poland

Location

SPZOZ Szpital Uniwersytecki w Krakowie

Krakow, 31-501, Poland

Location

National Institute of Cardiology

Warsaw, 04-628, Poland

Location

Military Hospital

Wroclaw, 50-891, Poland

Location

Hospital De Santa Cruz

Carnaxide, 2799-532, Portugal

Location

National Heart Centre Singapore

Singapore, 168752, Singapore

Location

Guys and St. Thomas NHS Foundation Trust St. Thomas Hospital

London, England, SE1 7EH, United Kingdom

Location

James Cook University Hospital

Middlesbrough, England, TS4 3BW, United Kingdom

Location

John Radcliffe Infirmary Oxford II

Oxford, England, OX3 9DU, United Kingdom

Location

Royal Victoria Hospital

Belfast, Ireland, BT12 6BA, United Kingdom

Location

Golden Jubilee National Hospital

Clydebank, G81 4HX, United Kingdom

Location

Southampton University Hospital

Southampton, SO16 6YD, United Kingdom

Location

Related Publications (2)

• 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.

  PMID: 21470815 RESULT

• 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.

  PMID: 29217001 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Aspirin; thienopyridine

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Results Point of Contact

• Title: Ruth Starzyk, PhD
• Organization: Boston Scientific Corporation

ruth.starzyk@bsci.com

508-683-6577

Study Officials

• Peter M Maurer, MPH

  Boston Scientific Corporation

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2009
• First Posted: January 15, 2009
• Study Start: January 1, 2009
• Primary Completion: September 1, 2010
• Study Completion: December 1, 2014
• Last Updated: March 27, 2019
• Results First Posted: January 27, 2012

Record last verified: 2019-03

Locations

PT (1); AU (4); US (75); JP (10); GB (6); DK (2); MY (2); LA (1); NL (4); DE (6); FR (6); NZ (3); PL (4); BE (4); SG (1); FI (3)