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
Identifieur interne : 006D98 ( Main/Exploration ); précédent : 006D97; suivant : 006D99A 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
Auteurs : Gregg W. Stone [États-Unis] ; Paul S. Teirstein [États-Unis] ; Ian T. Meredith [Australie] ; Bruno Farah [France] ; Christophe L. Dubois [Belgique] ; Robert L. Feldman [États-Unis] ; Joseph Dens [Belgique] ; Nobuhisa Hagiwara [Japon] ; Dominic J. Allocco [États-Unis] ; Keith D. Dawkins [États-Unis]Source :
- Journal of the American College of Cardiology [ 0735-1097 ] ; 2011.
Descripteurs français
- Pascal (Inist)
- Wicri :
- topic : Prospective, Platine.
English descriptors
- KwdEn :
Abstract
Objectives We sought to evaluate the clinical outcomes with a novel platinum chromium everolimus-eluting stent (PtCr-EES) compared with a predicate cobalt chromium everolimus-eluting stent (CoCr-EES) in patients undergoing percutaneous coronary intervention (PCI). Background Randomized trials have demonstrated an excellent safety and efficacy profile for the CoCr-EES. The PtCr-EES uses the identical antiproliferative agent and polymer but with a novel platinum chromium scaffold designed for enhanced deliverability, vessel conformability, side-branch access, radiopacity, radial strength, and fracture resistance. Methods A total of 1,530 patients undergoing PCI of 1 or 2 de novo native lesions were randomized at 132 worldwide sites to CoCr-EES (n = 762) or PtCr-EES (n = 768). The primary endpoint was the 12-month rate of target lesion failure (TLF), the composite of target vessel-related cardiac death, target vessel-related myocardial infarction (MI), or ischemia-driven target lesion revascularization (TLR) in the per-protocol population (patients who received ≥1 assigned study stent), powered for noninferiority. Results The 12-month rate of TLF in the per-protocol population occurred in 2.9% versus 3.4% of patients assigned to CoCr-EES versus PtCr-EES, respectively (difference: 0.5%, 95% confidence interval: -1.3% to 2.3%, Pnoninferiority = 0.001, psuperiority = 0.60). By intention-to-treat, there were no significant differences between CoCr-EES and PtCr-EES in the 12-month rates of TLF (3.2% vs. 3.5%, p = 0.72), cardiac death or MI (2.5% vs. 2.0%, p = 0.56), TLR (1.9% vs. 1.9%, p = 0.96), or Academic Research Consortium definite or probable stent thrombosis (0.4% vs. 0.4%, p = 1.00). Conclusions In this large-scale, prospective, single-blind randomized trial, a novel PtCr-EES was noninferior to the predicate CoCr-EES for TLF, with nonsignificant differences in measures of safety and efficacy through 12-month follow-up after PCI. (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: NCT00823212)
Affiliations:
- Australie, Belgique, France, Japon, États-Unis
- Californie, Floride, Massachusetts, Midi-Pyrénées, Occitanie (région administrative), Région de Kantō, État de New York
- Tokyo, Toulouse
Links toward previous steps (curation, corpus...)
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Stone</name><affiliation wicri:level="2"><inist:fA14 i1="01"><s1>Columbia University Medical Center/New York-Presbyterian Hospital and the Cardiovascular Research Foundation, New York</s1><s2>New York</s2><s3>USA</s3><sZ>1 aut.</sZ></inist:fA14><country>États-Unis</country><placeName><region type="state">État de New York</region></placeName></affiliation></author><author><name sortKey="Teirstein, Paul S" sort="Teirstein, Paul S" uniqKey="Teirstein P" first="Paul S." last="Teirstein">Paul S. Teirstein</name><affiliation wicri:level="2"><inist:fA14 i1="02"><s1>Scripps Clinic, Division of Cardiovascular Diseases</s1><s2>La Jolla, California</s2><s3>USA</s3><sZ>2 aut.</sZ></inist:fA14><country>États-Unis</country><placeName><region type="state">Californie</region></placeName></affiliation></author><author><name sortKey="Meredith, Ian T" sort="Meredith, Ian T" uniqKey="Meredith I" first="Ian T." last="Meredith">Ian T. Meredith</name><affiliation wicri:level="1"><inist:fA14 i1="03"><s1>MonashHEART, South- ern Health, Monash Medical Centre</s1><s2>Clayton, Victoria</s2><s3>AUS</s3><sZ>3 aut.</sZ></inist:fA14><country>Australie</country><wicri:noRegion>Clayton, Victoria</wicri:noRegion></affiliation></author><author><name sortKey="Farah, Bruno" sort="Farah, Bruno" uniqKey="Farah B" first="Bruno" last="Farah">Bruno Farah</name><affiliation wicri:level="3"><inist:fA14 i1="04"><s1>Clinique Pasteur</s1><s2>Toulouse</s2><s3>FRA</s3><sZ>4 aut.</sZ></inist:fA14><country>France</country><placeName><region type="region">Occitanie (région administrative)</region><region type="old region">Midi-Pyrénées</region><settlement type="city">Toulouse</settlement></placeName></affiliation></author><author><name sortKey="Dubois, Christophe L" sort="Dubois, Christophe L" uniqKey="Dubois C" first="Christophe L." last="Dubois">Christophe L. Dubois</name><affiliation wicri:level="1"><inist:fA14 i1="05"><s1>UZ Gasthuisberg</s1><s2>Leuven</s2><s3>BEL</s3><sZ>5 aut.</sZ></inist:fA14><country>Belgique</country><wicri:noRegion>UZ Gasthuisberg</wicri:noRegion></affiliation></author><author><name sortKey="Feldman, Robert L" sort="Feldman, Robert L" uniqKey="Feldman R" first="Robert L." last="Feldman">Robert L. Feldman</name><affiliation wicri:level="2"><inist:fA14 i1="06"><s1>Munroe Regional Medical Center</s1><s2>Ocala, Florida</s2><s3>USA</s3><sZ>6 aut.</sZ></inist:fA14><country>États-Unis</country><placeName><region type="state">Floride</region></placeName></affiliation></author><author><name sortKey="Dens, Joseph" sort="Dens, Joseph" uniqKey="Dens J" first="Joseph" last="Dens">Joseph Dens</name><affiliation wicri:level="1"><inist:fA14 i1="07"><s1>Ziekenhuis Oost Limburg</s1><s2>Genk</s2><s3>BEL</s3><sZ>7 aut.</sZ></inist:fA14><country>Belgique</country><wicri:noRegion>Ziekenhuis Oost Limburg</wicri:noRegion></affiliation></author><author><name sortKey="Hagiwara, Nobuhisa" sort="Hagiwara, Nobuhisa" uniqKey="Hagiwara N" first="Nobuhisa" last="Hagiwara">Nobuhisa Hagiwara</name><affiliation wicri:level="3"><inist:fA14 i1="08"><s1>Tokyo Women's Medical University Hospital</s1><s2>Shinjuku, Tokyo</s2><s3>JPN</s3><sZ>8 aut.</sZ></inist:fA14><country>Japon</country><placeName><settlement type="city">Tokyo</settlement><region type="région">Région de Kantō</region></placeName></affiliation></author><author><name sortKey="Allocco, Dominic J" sort="Allocco, Dominic J" uniqKey="Allocco D" first="Dominic J." last="Allocco">Dominic J. Allocco</name><affiliation wicri:level="2"><inist:fA14 i1="09"><s1>Boston Scientific Corporation</s1><s2>Natick, Massachusetts</s2><s3>USA</s3><sZ>9 aut.</sZ><sZ>10 aut.</sZ></inist:fA14><country>États-Unis</country><placeName><region type="state">Massachusetts</region></placeName></affiliation></author><author><name sortKey="Dawkins, Keith D" sort="Dawkins, Keith D" uniqKey="Dawkins K" first="Keith D." last="Dawkins">Keith D. Dawkins</name><affiliation wicri:level="2"><inist:fA14 i1="09"><s1>Boston Scientific Corporation</s1><s2>Natick, Massachusetts</s2><s3>USA</s3><sZ>9 aut.</sZ><sZ>10 aut.</sZ></inist:fA14><country>États-Unis</country><placeName><region type="state">Massachusetts</region></placeName></affiliation></author></analytic><series><title level="j" type="main">Journal of the American College of Cardiology</title><title level="j" type="abbreviated">J. Am. Coll. Cardiol.</title><idno type="ISSN">0735-1097</idno><imprint><date when="2011">2011</date></imprint></series></biblStruct></sourceDesc><seriesStmt><title level="j" type="main">Journal of the American College of Cardiology</title><title level="j" type="abbreviated">J. Am. Coll. Cardiol.</title><idno type="ISSN">0735-1097</idno></seriesStmt></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Carboplatin</term><term>Cardiology</term><term>Circulatory system</term><term>Cisplatin</term><term>Coronary artery</term><term>Coronary heart disease</term><term>De novo</term><term>Drug eluting stent</term><term>Elements</term><term>Evaluation</term><term>Everolimus</term><term>Immunosuppressive agent</term><term>Instrumentation therapy</term><term>Lesion</term><term>Multicenter study</term><term>Platinum</term><term>Prospective</term><term>Randomization</term><term>System</term></keywords><keywords scheme="Pascal" xml:lang="fr"><term>Cardiopathie coronaire</term><term>Prospective</term><term>Randomisation</term><term>Evaluation</term><term>Immunodépresseur</term><term>Evérolimus</term><term>Stent à élution médicamenteuse</term><term>Artère coronaire</term><term>Cisplatine</term><term>Platine</term><term>Carboplatine</term><term>Etude multicentrique</term><term>Système</term><term>Elément</term><term>De novo</term><term>Lésion</term><term>Appareil circulatoire</term><term>Cardiologie</term><term>Traitement instrumental</term></keywords><keywords scheme="Wicri" type="topic" xml:lang="fr"><term>Prospective</term><term>Platine</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">Objectives We sought to evaluate the clinical outcomes with a novel platinum chromium everolimus-eluting stent (PtCr-EES) compared with a predicate cobalt chromium everolimus-eluting stent (CoCr-EES) in patients undergoing percutaneous coronary intervention (PCI). Background Randomized trials have demonstrated an excellent safety and efficacy profile for the CoCr-EES. The PtCr-EES uses the identical antiproliferative agent and polymer but with a novel platinum chromium scaffold designed for enhanced deliverability, vessel conformability, side-branch access, radiopacity, radial strength, and fracture resistance. Methods A total of 1,530 patients undergoing PCI of 1 or 2 de novo native lesions were randomized at 132 worldwide sites to CoCr-EES (n = 762) or PtCr-EES (n = 768). The primary endpoint was the 12-month rate of target lesion failure (TLF), the composite of target vessel-related cardiac death, target vessel-related myocardial infarction (MI), or ischemia-driven target lesion revascularization (TLR) in the per-protocol population (patients who received ≥1 assigned study stent), powered for noninferiority. Results The 12-month rate of TLF in the per-protocol population occurred in 2.9% versus 3.4% of patients assigned to CoCr-EES versus PtCr-EES, respectively (difference: 0.5%, 95% confidence interval: -1.3% to 2.3%, P<sub>noninferiority</sub> = 0.001, p<sub>superiority</sub> = 0.60). By intention-to-treat, there were no significant differences between CoCr-EES and PtCr-EES in the 12-month rates of TLF (3.2% vs. 3.5%, p = 0.72), cardiac death or MI (2.5% vs. 2.0%, p = 0.56), TLR (1.9% vs. 1.9%, p = 0.96), or Academic Research Consortium definite or probable stent thrombosis (0.4% vs. 0.4%, p = 1.00). Conclusions In this large-scale, prospective, single-blind randomized trial, a novel PtCr-EES was noninferior to the predicate CoCr-EES for TLF, with nonsignificant differences in measures of safety and efficacy through 12-month follow-up after PCI. (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: NCT00823212)</div></front></TEI><affiliations><list><country><li>Australie</li><li>Belgique</li><li>France</li><li>Japon</li><li>États-Unis</li></country><region><li>Californie</li><li>Floride</li><li>Massachusetts</li><li>Midi-Pyrénées</li><li>Occitanie (région administrative)</li><li>Région de Kantō</li><li>État de New York</li></region><settlement><li>Tokyo</li><li>Toulouse</li></settlement></list><tree><country name="États-Unis"><region name="État de New York"><name sortKey="Stone, Gregg W" sort="Stone, Gregg W" uniqKey="Stone G" first="Gregg W." last="Stone">Gregg W. Stone</name></region><name sortKey="Allocco, Dominic J" sort="Allocco, Dominic J" uniqKey="Allocco D" first="Dominic J." last="Allocco">Dominic J. Allocco</name><name sortKey="Dawkins, Keith D" sort="Dawkins, Keith D" uniqKey="Dawkins K" first="Keith D." last="Dawkins">Keith D. Dawkins</name><name sortKey="Feldman, Robert L" sort="Feldman, Robert L" uniqKey="Feldman R" first="Robert L." last="Feldman">Robert L. Feldman</name><name sortKey="Teirstein, Paul S" sort="Teirstein, Paul S" uniqKey="Teirstein P" first="Paul S." last="Teirstein">Paul S. Teirstein</name></country><country name="Australie"><noRegion><name sortKey="Meredith, Ian T" sort="Meredith, Ian T" uniqKey="Meredith I" first="Ian T." last="Meredith">Ian T. Meredith</name></noRegion></country><country name="France"><region name="Occitanie (région administrative)"><name sortKey="Farah, Bruno" sort="Farah, Bruno" uniqKey="Farah B" first="Bruno" last="Farah">Bruno Farah</name></region></country><country name="Belgique"><noRegion><name sortKey="Dubois, Christophe L" sort="Dubois, Christophe L" uniqKey="Dubois C" first="Christophe L." last="Dubois">Christophe L. Dubois</name></noRegion><name sortKey="Dens, Joseph" sort="Dens, Joseph" uniqKey="Dens J" first="Joseph" last="Dens">Joseph Dens</name></country><country name="Japon"><region name="Région de Kantō"><name sortKey="Hagiwara, Nobuhisa" sort="Hagiwara, Nobuhisa" uniqKey="Hagiwara N" first="Nobuhisa" last="Hagiwara">Nobuhisa Hagiwara</name></region></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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