2-Year Outcomes of High Bleeding Risk Patients After Polymer-Free Drug-Coated Stents.
Identifieur interne : 001357 ( PubMed/Checkpoint ); précédent : 001356; suivant : 0013582-Year Outcomes of High Bleeding Risk Patients After Polymer-Free Drug-Coated Stents.
Auteurs : Philippe Garot [France] ; Marie-Claude Morice [France] ; Damras Tresukosol [Thaïlande] ; Stuart J. Pocock [Royaume-Uni] ; Ian T. Meredith [Australie] ; Alexandre Abizaid [Brésil] ; Didier Carrié [France] ; Christoph Naber [Allemagne] ; Andres I Iguez [Espagne] ; Suneel Talwar [Royaume-Uni] ; Ian B A. Menown [Royaume-Uni] ; Evald H. Christiansen [Danemark] ; John Gregson [Royaume-Uni] ; Samuel Copt [Suisse] ; Thomas Hovasse [France] ; Philipp Lurz [Allemagne] ; Luc Maillard [France] ; Florian Krackhardt [Allemagne] ; Paul Ong [Singapour] ; Jonathan Byrne [Royaume-Uni] ; Simon Redwood [Royaume-Uni] ; Ute Windhövel [France] ; Samantha Greene [Suisse] ; Hans-Peter Stoll [Suisse] ; Philip Urban [Suisse]Source :
- Journal of the American College of Cardiology [ 1558-3597 ] ; 2017.
Descripteurs français
- KwdFr :
- Adulte d'âge moyen, Angioplastie coronaire par ballonnet (instrumentation), Antiagrégants plaquettaires (administration et posologie), Antiagrégants plaquettaires (effets indésirables), Association de médicaments, Endoprothèses (effets indésirables), Endoprothèses à élution de substances (effets indésirables), Estimation de Kaplan-Meier, Femelle, Humains, Hémorragie (), Infarctus du myocarde (), Infarctus du myocarde (mortalité), Maladie coronarienne (), Maladie coronarienne (mortalité), Modèles de hasards proportionnels, Mort, Mâle, Méthode en double aveugle, Risque, Sirolimus (administration et posologie), Sirolimus (analogues et dérivés), Sirolimus (effets indésirables), Statistiques comme sujet, Sujet âgé, Sujet âgé de 80 ans ou plus, Taux de survie, Thrombose coronarienne (), Thrombose coronarienne (mortalité), Études prospectives.
- MESH :
- administration et posologie : Antiagrégants plaquettaires, Sirolimus.
- analogues et dérivés : Sirolimus.
- effets indésirables : Antiagrégants plaquettaires, Endoprothèses, Endoprothèses à élution de substances, Sirolimus.
- mortalité : Infarctus du myocarde, Maladie coronarienne, Thrombose coronarienne.
- Adulte d'âge moyen, Angioplastie coronaire par ballonnet, Association de médicaments, Estimation de Kaplan-Meier, Femelle, Humains, Hémorragie, Infarctus du myocarde, Maladie coronarienne, Modèles de hasards proportionnels, Mort, Mâle, Méthode en double aveugle, Risque, Statistiques comme sujet, Sujet âgé, Sujet âgé de 80 ans ou plus, Taux de survie, Thrombose coronarienne, Études prospectives.
English descriptors
- KwdEn :
- Aged, Aged, 80 and over, Angioplasty, Balloon, Coronary (instrumentation), Coronary Disease (mortality), Coronary Disease (therapy), Coronary Thrombosis (mortality), Coronary Thrombosis (prevention & control), Death, Double-Blind Method, Drug Therapy, Combination, Drug-Eluting Stents (adverse effects), Female, Hemorrhage (chemically induced), Humans, Kaplan-Meier Estimate, Male, Middle Aged, Myocardial Infarction (mortality), Myocardial Infarction (prevention & control), Platelet Aggregation Inhibitors (administration & dosage), Platelet Aggregation Inhibitors (adverse effects), Proportional Hazards Models, Prospective Studies, Risk, Sirolimus (administration & dosage), Sirolimus (adverse effects), Sirolimus (analogs & derivatives), Statistics as Topic, Stents (adverse effects), Survival Rate.
- MESH :
- chemical , administration & dosage : Platelet Aggregation Inhibitors, Sirolimus.
- adverse effects : Drug-Eluting Stents, Platelet Aggregation Inhibitors, Sirolimus, Stents.
- chemical , analogs & derivatives : Sirolimus.
- chemically induced : Hemorrhage.
- instrumentation : Angioplasty, Balloon, Coronary.
- mortality : Coronary Disease, Coronary Thrombosis, Myocardial Infarction.
- prevention & control : Coronary Thrombosis, Myocardial Infarction.
- therapy : Coronary Disease.
- Aged, Aged, 80 and over, Death, Double-Blind Method, Drug Therapy, Combination, Female, Humans, Kaplan-Meier Estimate, Male, Middle Aged, Proportional Hazards Models, Prospective Studies, Risk, Statistics as Topic, Survival Rate.
Abstract
A 1-year follow-up, polymer-free metallic stent coated with biolimus-A9 followed by 1-month dual antiplatelet therapy is safer and more effective than a bare-metal stent (BMS) for patients with high risk of bleeding.
DOI: 10.1016/j.jacc.2016.10.009
PubMed: 27806919
Affiliations:
- Allemagne, Australie, Brésil, Danemark, Espagne, France, Royaume-Uni, Singapour, Suisse, Thaïlande
- Angleterre, Berlin, District de Leipzig, Grand Londres, Midi-Pyrénées, Occitanie (région administrative), Saxe (Land), Victoria (État), État de São Paulo
- Berlin, Leipzig, Londres, Melbourne, São Paulo, Toulouse
Links toward previous steps (curation, corpus...)
Links to Exploration step
pubmed:27806919Le document en format XML
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<author><name sortKey="Morice, Marie Claude" sort="Morice, Marie Claude" uniqKey="Morice M" first="Marie-Claude" last="Morice">Marie-Claude Morice</name>
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<author><name sortKey="Meredith, Ian T" sort="Meredith, Ian T" uniqKey="Meredith I" first="Ian T" last="Meredith">Ian T. Meredith</name>
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<author><name sortKey="Abizaid, Alexandre" sort="Abizaid, Alexandre" uniqKey="Abizaid A" first="Alexandre" last="Abizaid">Alexandre Abizaid</name>
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<country xml:lang="fr">Brésil</country>
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<author><name sortKey="Carrie, Didier" sort="Carrie, Didier" uniqKey="Carrie D" first="Didier" last="Carrié">Didier Carrié</name>
<affiliation wicri:level="3"><nlm:affiliation>Cardiology Department, Toulouse Rangueil Hospital, Toulouse, France.</nlm:affiliation>
<country xml:lang="fr">France</country>
<wicri:regionArea>Cardiology Department, Toulouse Rangueil Hospital, Toulouse</wicri:regionArea>
<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="Naber, Christoph" sort="Naber, Christoph" uniqKey="Naber C" first="Christoph" last="Naber">Christoph Naber</name>
<affiliation wicri:level="1"><nlm:affiliation>Department of Medical Statistics, Contilia Heart and Vascular Centre, Elisabeth Krankenhaus, Essen, Germany.</nlm:affiliation>
<country xml:lang="fr">Allemagne</country>
<wicri:regionArea>Department of Medical Statistics, Contilia Heart and Vascular Centre, Elisabeth Krankenhaus, Essen</wicri:regionArea>
<wicri:noRegion>Essen</wicri:noRegion>
<wicri:noRegion>Essen</wicri:noRegion>
<wicri:noRegion>Essen</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="I Iguez, Andres" sort="I Iguez, Andres" uniqKey="I Iguez A" first="Andres" last="I Iguez">Andres I Iguez</name>
<affiliation wicri:level="1"><nlm:affiliation>Cardiology Department, Complejo Hospitalario Universitario de Vigo, Hospital Meixoeiro, Meixoeiro, Spain.</nlm:affiliation>
<country xml:lang="fr">Espagne</country>
<wicri:regionArea>Cardiology Department, Complejo Hospitalario Universitario de Vigo, Hospital Meixoeiro, Meixoeiro</wicri:regionArea>
<wicri:noRegion>Meixoeiro</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Talwar, Suneel" sort="Talwar, Suneel" uniqKey="Talwar S" first="Suneel" last="Talwar">Suneel Talwar</name>
<affiliation wicri:level="1"><nlm:affiliation>Dorset Heart Centre, Royal Bournemouth Hospital, Bournemouth, United Kingdom.</nlm:affiliation>
<country xml:lang="fr">Royaume-Uni</country>
<wicri:regionArea>Dorset Heart Centre, Royal Bournemouth Hospital, Bournemouth</wicri:regionArea>
<wicri:noRegion>Bournemouth</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Menown, Ian B A" sort="Menown, Ian B A" uniqKey="Menown I" first="Ian B A" last="Menown">Ian B A. Menown</name>
<affiliation wicri:level="1"><nlm:affiliation>Department of Cardiology, Craigavon Cardiac Center, Portadown, United Kingdom.</nlm:affiliation>
<country xml:lang="fr">Royaume-Uni</country>
<wicri:regionArea>Department of Cardiology, Craigavon Cardiac Center, Portadown</wicri:regionArea>
<wicri:noRegion>Portadown</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Christiansen, Evald H" sort="Christiansen, Evald H" uniqKey="Christiansen E" first="Evald H" last="Christiansen">Evald H. Christiansen</name>
<affiliation wicri:level="1"><nlm:affiliation>Department of Cardiology, Aarhus University Hospital, Skejby, Denmark.</nlm:affiliation>
<country xml:lang="fr">Danemark</country>
<wicri:regionArea>Department of Cardiology, Aarhus University Hospital, Skejby</wicri:regionArea>
<wicri:noRegion>Skejby</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Gregson, John" sort="Gregson, John" uniqKey="Gregson J" first="John" last="Gregson">John Gregson</name>
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<country xml:lang="fr">Royaume-Uni</country>
<wicri:regionArea>London School of Hygiene and Tropical Medicine, London</wicri:regionArea>
<placeName><settlement type="city">Londres</settlement>
<region type="country">Angleterre</region>
<region type="région" nuts="1">Grand Londres</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Copt, Samuel" sort="Copt, Samuel" uniqKey="Copt S" first="Samuel" last="Copt">Samuel Copt</name>
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<country xml:lang="fr">Suisse</country>
<wicri:regionArea>Biosensors Europe, Morges</wicri:regionArea>
<wicri:noRegion>Morges</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Hovasse, Thomas" sort="Hovasse, Thomas" uniqKey="Hovasse T" first="Thomas" last="Hovasse">Thomas Hovasse</name>
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<country xml:lang="fr">France</country>
<wicri:regionArea>Hôpital Privé Jacques Cartier, Institut Cardiovasculaire Paris-sud Ramsay-Générale de Santé, Massy</wicri:regionArea>
<wicri:noRegion>Massy</wicri:noRegion>
<wicri:noRegion>Massy</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Lurz, Philipp" sort="Lurz, Philipp" uniqKey="Lurz P" first="Philipp" last="Lurz">Philipp Lurz</name>
<affiliation wicri:level="3"><nlm:affiliation>Department of Internal Medicine/Cardiology, Universität Leipzig-Herzzentrum, Leipzig, Germany.</nlm:affiliation>
<country xml:lang="fr">Allemagne</country>
<wicri:regionArea>Department of Internal Medicine/Cardiology, Universität Leipzig-Herzzentrum, Leipzig</wicri:regionArea>
<placeName><region type="land" nuts="1">Saxe (Land)</region>
<region type="district" nuts="2">District de Leipzig</region>
<settlement type="city">Leipzig</settlement>
</placeName>
</affiliation>
</author>
<author><name sortKey="Maillard, Luc" sort="Maillard, Luc" uniqKey="Maillard L" first="Luc" last="Maillard">Luc Maillard</name>
<affiliation wicri:level="1"><nlm:affiliation>Service de Cardiologie, Groupement de Coopération Sanitaire Etablissements de Santé, Axium-Rambot, City, France.</nlm:affiliation>
<country xml:lang="fr">France</country>
<wicri:regionArea>Service de Cardiologie, Groupement de Coopération Sanitaire Etablissements de Santé, Axium-Rambot, City</wicri:regionArea>
<wicri:noRegion>City</wicri:noRegion>
<wicri:noRegion>City</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Krackhardt, Florian" sort="Krackhardt, Florian" uniqKey="Krackhardt F" first="Florian" last="Krackhardt">Florian Krackhardt</name>
<affiliation wicri:level="3"><nlm:affiliation>Department of Cardiology, Charité Campus Virchow Klinikum, Berlin, Germany.</nlm:affiliation>
<country xml:lang="fr">Allemagne</country>
<wicri:regionArea>Department of Cardiology, Charité Campus Virchow Klinikum, Berlin</wicri:regionArea>
<placeName><region type="land" nuts="3">Berlin</region>
<settlement type="city">Berlin</settlement>
</placeName>
</affiliation>
</author>
<author><name sortKey="Ong, Paul" sort="Ong, Paul" uniqKey="Ong P" first="Paul" last="Ong">Paul Ong</name>
<affiliation wicri:level="1"><nlm:affiliation>Tan Tock Seng Hospital, Singapore.</nlm:affiliation>
<country xml:lang="fr">Singapour</country>
<wicri:regionArea>Tan Tock Seng Hospital</wicri:regionArea>
</affiliation>
</author>
<author><name sortKey="Byrne, Jonathan" sort="Byrne, Jonathan" uniqKey="Byrne J" first="Jonathan" last="Byrne">Jonathan Byrne</name>
<affiliation wicri:level="3"><nlm:affiliation>Department of Cardiology, King's College Hospital, London, United Kingdom.</nlm:affiliation>
<country xml:lang="fr">Royaume-Uni</country>
<wicri:regionArea>Department of Cardiology, King's College Hospital, London</wicri:regionArea>
<placeName><settlement type="city">Londres</settlement>
<region type="country">Angleterre</region>
<region type="région" nuts="1">Grand Londres</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Redwood, Simon" sort="Redwood, Simon" uniqKey="Redwood S" first="Simon" last="Redwood">Simon Redwood</name>
<affiliation wicri:level="3"><nlm:affiliation>St. Thomas Hospital, London, United Kingdom.</nlm:affiliation>
<country xml:lang="fr">Royaume-Uni</country>
<wicri:regionArea>St. Thomas Hospital, London</wicri:regionArea>
<placeName><settlement type="city">Londres</settlement>
<region type="country">Angleterre</region>
<region type="région" nuts="1">Grand Londres</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Windhovel, Ute" sort="Windhovel, Ute" uniqKey="Windhovel U" first="Ute" last="Windhövel">Ute Windhövel</name>
<affiliation wicri:level="1"><nlm:affiliation>Cardiovascular European Research Center, Massy, France.</nlm:affiliation>
<country xml:lang="fr">France</country>
<wicri:regionArea>Cardiovascular European Research Center, Massy</wicri:regionArea>
<wicri:noRegion>Massy</wicri:noRegion>
<wicri:noRegion>Massy</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Greene, Samantha" sort="Greene, Samantha" uniqKey="Greene S" first="Samantha" last="Greene">Samantha Greene</name>
<affiliation wicri:level="1"><nlm:affiliation>Biosensors Europe, Morges, Switzerland.</nlm:affiliation>
<country xml:lang="fr">Suisse</country>
<wicri:regionArea>Biosensors Europe, Morges</wicri:regionArea>
<wicri:noRegion>Morges</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Stoll, Hans Peter" sort="Stoll, Hans Peter" uniqKey="Stoll H" first="Hans-Peter" last="Stoll">Hans-Peter Stoll</name>
<affiliation wicri:level="1"><nlm:affiliation>Biosensors Europe, Morges, Switzerland.</nlm:affiliation>
<country xml:lang="fr">Suisse</country>
<wicri:regionArea>Biosensors Europe, Morges</wicri:regionArea>
<wicri:noRegion>Morges</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Urban, Philip" sort="Urban, Philip" uniqKey="Urban P" first="Philip" last="Urban">Philip Urban</name>
<affiliation wicri:level="1"><nlm:affiliation>Cardiovascular Department, Hôpital de la Tour, Geneva, Switzerland. Electronic address: philip.urban@latour.ch.</nlm:affiliation>
<country xml:lang="fr">Suisse</country>
<wicri:regionArea>Cardiovascular Department, Hôpital de la Tour, Geneva</wicri:regionArea>
<wicri:noRegion>Geneva</wicri:noRegion>
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<series><title level="j">Journal of the American College of Cardiology</title>
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<term>Coronary Disease (therapy)</term>
<term>Coronary Thrombosis (mortality)</term>
<term>Coronary Thrombosis (prevention & control)</term>
<term>Death</term>
<term>Double-Blind Method</term>
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<term>Hemorrhage (chemically induced)</term>
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<term>Kaplan-Meier Estimate</term>
<term>Male</term>
<term>Middle Aged</term>
<term>Myocardial Infarction (mortality)</term>
<term>Myocardial Infarction (prevention & control)</term>
<term>Platelet Aggregation Inhibitors (administration & dosage)</term>
<term>Platelet Aggregation Inhibitors (adverse effects)</term>
<term>Proportional Hazards Models</term>
<term>Prospective Studies</term>
<term>Risk</term>
<term>Sirolimus (administration & dosage)</term>
<term>Sirolimus (adverse effects)</term>
<term>Sirolimus (analogs & derivatives)</term>
<term>Statistics as Topic</term>
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<term>Angioplastie coronaire par ballonnet (instrumentation)</term>
<term>Antiagrégants plaquettaires (administration et posologie)</term>
<term>Antiagrégants plaquettaires (effets indésirables)</term>
<term>Association de médicaments</term>
<term>Endoprothèses (effets indésirables)</term>
<term>Endoprothèses à élution de substances (effets indésirables)</term>
<term>Estimation de Kaplan-Meier</term>
<term>Femelle</term>
<term>Humains</term>
<term>Hémorragie ()</term>
<term>Infarctus du myocarde ()</term>
<term>Infarctus du myocarde (mortalité)</term>
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<term>Maladie coronarienne (mortalité)</term>
<term>Modèles de hasards proportionnels</term>
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<term>Sirolimus (analogues et dérivés)</term>
<term>Sirolimus (effets indésirables)</term>
<term>Statistiques comme sujet</term>
<term>Sujet âgé</term>
<term>Sujet âgé de 80 ans ou plus</term>
<term>Taux de survie</term>
<term>Thrombose coronarienne ()</term>
<term>Thrombose coronarienne (mortalité)</term>
<term>Études prospectives</term>
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<term>Myocardial Infarction</term>
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<term>Maladie coronarienne</term>
<term>Thrombose coronarienne</term>
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<term>Myocardial Infarction</term>
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<term>Aged, 80 and over</term>
<term>Death</term>
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<term>Female</term>
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<term>Association de médicaments</term>
<term>Estimation de Kaplan-Meier</term>
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<front><div type="abstract" xml:lang="en">A 1-year follow-up, polymer-free metallic stent coated with biolimus-A9 followed by 1-month dual antiplatelet therapy is safer and more effective than a bare-metal stent (BMS) for patients with high risk of bleeding.</div>
</front>
</TEI>
<pubmed><MedlineCitation Status="MEDLINE" Owner="NLM"><PMID Version="1">27806919</PMID>
<DateCreated><Year>2016</Year>
<Month>11</Month>
<Day>03</Day>
</DateCreated>
<DateCompleted><Year>2017</Year>
<Month>07</Month>
<Day>12</Day>
</DateCompleted>
<DateRevised><Year>2017</Year>
<Month>09</Month>
<Day>03</Day>
</DateRevised>
<Article PubModel="Print-Electronic"><Journal><ISSN IssnType="Electronic">1558-3597</ISSN>
<JournalIssue CitedMedium="Internet"><Volume>69</Volume>
<Issue>2</Issue>
<PubDate><Year>2017</Year>
<Month>Jan</Month>
<Day>17</Day>
</PubDate>
</JournalIssue>
<Title>Journal of the American College of Cardiology</Title>
<ISOAbbreviation>J. Am. Coll. Cardiol.</ISOAbbreviation>
</Journal>
<ArticleTitle>2-Year Outcomes of High Bleeding Risk Patients After Polymer-Free Drug-Coated Stents.</ArticleTitle>
<Pagination><MedlinePgn>162-171</MedlinePgn>
</Pagination>
<ELocationID EIdType="pii" ValidYN="Y">S0735-1097(16)36602-5</ELocationID>
<ELocationID EIdType="doi" ValidYN="Y">10.1016/j.jacc.2016.10.009</ELocationID>
<Abstract><AbstractText Label="BACKGROUND" NlmCategory="BACKGROUND">A 1-year follow-up, polymer-free metallic stent coated with biolimus-A9 followed by 1-month dual antiplatelet therapy is safer and more effective than a bare-metal stent (BMS) for patients with high risk of bleeding.</AbstractText>
<AbstractText Label="OBJECTIVES" NlmCategory="OBJECTIVE">This study analyzed 2-year outcomes to determine whether these benefits are maintained.</AbstractText>
<AbstractText Label="METHODS" NlmCategory="METHODS">In a prospective, multicenter, double-blind trial, we randomized 2,466 high bleeding risk patients to receive a drug-coated stent (DCS) or a BMS followed by 1-month dual antiplatelet therapy. The primary safety endpoint was a composite of cardiac death, myocardial infarction, or stent thrombosis. The primary efficacy endpoint was clinically driven target lesion revascularization.</AbstractText>
<AbstractText Label="RESULTS" NlmCategory="RESULTS">At 2 years, the primary safety endpoint had occurred in 147 DCS and 180 BMS patients (15.3%) (hazard ratio: 0.80; 95% confidence interval: 0.64 to 0.99; p = 0.039). Clinically driven target lesion revascularization occurred for 77 DCS and 136 BMS patients (12.0%) (hazard ratio: 0.54; 95% confidence interval: 0.41 to 0.72; p < 0.0001). Major bleeding occurred in 8.9% of DCS and 9.2% of BMS patients (p = 0.95), and a coronary thrombotic event (myocardial infarction and/or stent thrombosis) occurred in 8.2% of DCS and 10.6% of BMS patients (p = 0.045). One-year mortality was 27.1% for a major bleed and 26.3% for a thrombotic event. At 2 years, multivariate correlates of major bleeding were age >75 years, anemia, raised plasma creatinine, and planned long-term anticoagulation. Correlates of the primary safety endpoint were age, anemia, congestive heart failure, multivessel disease, number of stents implanted, and use of a BMS rather than a DCS.</AbstractText>
<AbstractText Label="CONCLUSIONS" NlmCategory="CONCLUSIONS">Safety and efficacy benefits of DCS over BMS were maintained for 2 years in high bleeding risk patients. Rates of major bleeding and coronary thrombotic events were no different and were associated with a substantial and comparable mortality risk. (A Prospective Randomized Comparison of the BioFreedom Biolimus A9 Drug Coated Stent Versus the Gazelle Bare Metal Stent in Patients With High Risk of Bleeding [LEADERS FREE]; NCT01623180).</AbstractText>
<CopyrightInformation>Copyright © 2017 The Authors. Published by Elsevier Inc. All rights reserved.</CopyrightInformation>
</Abstract>
<AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Garot</LastName>
<ForeName>Philippe</ForeName>
<Initials>P</Initials>
<AffiliationInfo><Affiliation>Hôpital Claude Galien, Institut Cardiovasculaire Paris-sud Ramsay-Générale de Santé, Quincy Sous-Sénart, France; Hôpital Privé Jacques Cartier, Institut Cardiovasculaire Paris-sud Ramsay-Générale de Santé, Massy, France.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Morice</LastName>
<ForeName>Marie-Claude</ForeName>
<Initials>MC</Initials>
<AffiliationInfo><Affiliation>Hôpital Privé Jacques Cartier, Institut Cardiovasculaire Paris-sud Ramsay-Générale de Santé, Massy, France.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Tresukosol</LastName>
<ForeName>Damras</ForeName>
<Initials>D</Initials>
<AffiliationInfo><Affiliation>Siriraj Hospital, Bangkok, Thailand.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Pocock</LastName>
<ForeName>Stuart J</ForeName>
<Initials>SJ</Initials>
<AffiliationInfo><Affiliation>London School of Hygiene and Tropical Medicine, London, United Kingdom.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Meredith</LastName>
<ForeName>Ian T</ForeName>
<Initials>IT</Initials>
<AffiliationInfo><Affiliation>MonashHeart and Monash University, Melbourne, Australia.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Abizaid</LastName>
<ForeName>Alexandre</ForeName>
<Initials>A</Initials>
<AffiliationInfo><Affiliation>Instituto Dante Pazzanese de Cardiologia, São Paulo, Brazil, and Hospital Albert Einstein, São Paulo, Brazil.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Carrié</LastName>
<ForeName>Didier</ForeName>
<Initials>D</Initials>
<AffiliationInfo><Affiliation>Cardiology Department, Toulouse Rangueil Hospital, Toulouse, France.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Naber</LastName>
<ForeName>Christoph</ForeName>
<Initials>C</Initials>
<AffiliationInfo><Affiliation>Department of Medical Statistics, Contilia Heart and Vascular Centre, Elisabeth Krankenhaus, Essen, Germany.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Iñiguez</LastName>
<ForeName>Andres</ForeName>
<Initials>A</Initials>
<AffiliationInfo><Affiliation>Cardiology Department, Complejo Hospitalario Universitario de Vigo, Hospital Meixoeiro, Meixoeiro, Spain.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Talwar</LastName>
<ForeName>Suneel</ForeName>
<Initials>S</Initials>
<AffiliationInfo><Affiliation>Dorset Heart Centre, Royal Bournemouth Hospital, Bournemouth, United Kingdom.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Menown</LastName>
<ForeName>Ian B A</ForeName>
<Initials>IBA</Initials>
<AffiliationInfo><Affiliation>Department of Cardiology, Craigavon Cardiac Center, Portadown, United Kingdom.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Christiansen</LastName>
<ForeName>Evald H</ForeName>
<Initials>EH</Initials>
<AffiliationInfo><Affiliation>Department of Cardiology, Aarhus University Hospital, Skejby, Denmark.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Gregson</LastName>
<ForeName>John</ForeName>
<Initials>J</Initials>
<AffiliationInfo><Affiliation>London School of Hygiene and Tropical Medicine, London, United Kingdom.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Copt</LastName>
<ForeName>Samuel</ForeName>
<Initials>S</Initials>
<AffiliationInfo><Affiliation>Biosensors Europe, Morges, Switzerland.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Hovasse</LastName>
<ForeName>Thomas</ForeName>
<Initials>T</Initials>
<AffiliationInfo><Affiliation>Hôpital Privé Jacques Cartier, Institut Cardiovasculaire Paris-sud Ramsay-Générale de Santé, Massy, France.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Lurz</LastName>
<ForeName>Philipp</ForeName>
<Initials>P</Initials>
<AffiliationInfo><Affiliation>Department of Internal Medicine/Cardiology, Universität Leipzig-Herzzentrum, Leipzig, Germany.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Maillard</LastName>
<ForeName>Luc</ForeName>
<Initials>L</Initials>
<AffiliationInfo><Affiliation>Service de Cardiologie, Groupement de Coopération Sanitaire Etablissements de Santé, Axium-Rambot, City, France.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Krackhardt</LastName>
<ForeName>Florian</ForeName>
<Initials>F</Initials>
<AffiliationInfo><Affiliation>Department of Cardiology, Charité Campus Virchow Klinikum, Berlin, Germany.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Ong</LastName>
<ForeName>Paul</ForeName>
<Initials>P</Initials>
<AffiliationInfo><Affiliation>Tan Tock Seng Hospital, Singapore.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Byrne</LastName>
<ForeName>Jonathan</ForeName>
<Initials>J</Initials>
<AffiliationInfo><Affiliation>Department of Cardiology, King's College Hospital, London, United Kingdom.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Redwood</LastName>
<ForeName>Simon</ForeName>
<Initials>S</Initials>
<AffiliationInfo><Affiliation>St. Thomas Hospital, London, United Kingdom.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Windhövel</LastName>
<ForeName>Ute</ForeName>
<Initials>U</Initials>
<AffiliationInfo><Affiliation>Cardiovascular European Research Center, Massy, France.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Greene</LastName>
<ForeName>Samantha</ForeName>
<Initials>S</Initials>
<AffiliationInfo><Affiliation>Biosensors Europe, Morges, Switzerland.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Stoll</LastName>
<ForeName>Hans-Peter</ForeName>
<Initials>HP</Initials>
<AffiliationInfo><Affiliation>Biosensors Europe, Morges, Switzerland.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Urban</LastName>
<ForeName>Philip</ForeName>
<Initials>P</Initials>
<AffiliationInfo><Affiliation>Cardiovascular Department, Hôpital de la Tour, Geneva, Switzerland. Electronic address: philip.urban@latour.ch.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><CollectiveName>LEADERS FREE Investigators</CollectiveName>
</Author>
</AuthorList>
<Language>eng</Language>
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<AccessionNumberList><AccessionNumber>NCT01623180</AccessionNumber>
</AccessionNumberList>
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<PublicationType UI="D016428">Journal Article</PublicationType>
<PublicationType UI="D016448">Multicenter Study</PublicationType>
<PublicationType UI="D016449">Randomized Controlled Trial</PublicationType>
</PublicationTypeList>
<ArticleDate DateType="Electronic"><Year>2016</Year>
<Month>10</Month>
<Day>30</Day>
</ArticleDate>
</Article>
<MedlineJournalInfo><Country>United States</Country>
<MedlineTA>J Am Coll Cardiol</MedlineTA>
<NlmUniqueID>8301365</NlmUniqueID>
<ISSNLinking>0735-1097</ISSNLinking>
</MedlineJournalInfo>
<ChemicalList><Chemical><RegistryNumber>0</RegistryNumber>
<NameOfSubstance UI="D010975">Platelet Aggregation Inhibitors</NameOfSubstance>
</Chemical>
<Chemical><RegistryNumber>U36PGF65JH</RegistryNumber>
<NameOfSubstance UI="C518022">umirolimus</NameOfSubstance>
</Chemical>
<Chemical><RegistryNumber>W36ZG6FT64</RegistryNumber>
<NameOfSubstance UI="D020123">Sirolimus</NameOfSubstance>
</Chemical>
</ChemicalList>
<CitationSubset>AIM</CitationSubset>
<CitationSubset>IM</CitationSubset>
<MeshHeadingList><MeshHeading><DescriptorName UI="D000368" MajorTopicYN="N">Aged</DescriptorName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D000369" MajorTopicYN="N">Aged, 80 and over</DescriptorName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D015906" MajorTopicYN="N">Angioplasty, Balloon, Coronary</DescriptorName>
<QualifierName UI="Q000295" MajorTopicYN="Y">instrumentation</QualifierName>
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<QualifierName UI="Q000401" MajorTopicYN="N">mortality</QualifierName>
<QualifierName UI="Q000628" MajorTopicYN="Y">therapy</QualifierName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D003328" MajorTopicYN="N">Coronary Thrombosis</DescriptorName>
<QualifierName UI="Q000401" MajorTopicYN="N">mortality</QualifierName>
<QualifierName UI="Q000517" MajorTopicYN="N">prevention & control</QualifierName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D003643" MajorTopicYN="N">Death</DescriptorName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D004311" MajorTopicYN="N">Double-Blind Method</DescriptorName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D004359" MajorTopicYN="N">Drug Therapy, Combination</DescriptorName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D054855" MajorTopicYN="N">Drug-Eluting Stents</DescriptorName>
<QualifierName UI="Q000009" MajorTopicYN="Y">adverse effects</QualifierName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D005260" MajorTopicYN="N">Female</DescriptorName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D006470" MajorTopicYN="N">Hemorrhage</DescriptorName>
<QualifierName UI="Q000139" MajorTopicYN="Y">chemically induced</QualifierName>
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<MeshHeading><DescriptorName UI="D006801" MajorTopicYN="N">Humans</DescriptorName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D053208" MajorTopicYN="N">Kaplan-Meier Estimate</DescriptorName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D008297" MajorTopicYN="N">Male</DescriptorName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D008875" MajorTopicYN="N">Middle Aged</DescriptorName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D009203" MajorTopicYN="N">Myocardial Infarction</DescriptorName>
<QualifierName UI="Q000401" MajorTopicYN="N">mortality</QualifierName>
<QualifierName UI="Q000517" MajorTopicYN="N">prevention & control</QualifierName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D010975" MajorTopicYN="N">Platelet Aggregation Inhibitors</DescriptorName>
<QualifierName UI="Q000008" MajorTopicYN="Y">administration & dosage</QualifierName>
<QualifierName UI="Q000009" MajorTopicYN="Y">adverse effects</QualifierName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D016016" MajorTopicYN="N">Proportional Hazards Models</DescriptorName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D011446" MajorTopicYN="N">Prospective Studies</DescriptorName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D012306" MajorTopicYN="N">Risk</DescriptorName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D020123" MajorTopicYN="N">Sirolimus</DescriptorName>
<QualifierName UI="Q000008" MajorTopicYN="N">administration & dosage</QualifierName>
<QualifierName UI="Q000009" MajorTopicYN="N">adverse effects</QualifierName>
<QualifierName UI="Q000031" MajorTopicYN="Y">analogs & derivatives</QualifierName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D013223" MajorTopicYN="N">Statistics as Topic</DescriptorName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D015607" MajorTopicYN="N">Stents</DescriptorName>
<QualifierName UI="Q000009" MajorTopicYN="Y">adverse effects</QualifierName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D015996" MajorTopicYN="N">Survival Rate</DescriptorName>
</MeshHeading>
</MeshHeadingList>
<KeywordList Owner="NOTNLM"><Keyword MajorTopicYN="N">bare-metal stent</Keyword>
<Keyword MajorTopicYN="N">bleeding</Keyword>
<Keyword MajorTopicYN="N">drug-coated stent</Keyword>
<Keyword MajorTopicYN="N">dual antiplatelet therapy</Keyword>
<Keyword MajorTopicYN="N">thrombosis</Keyword>
</KeywordList>
<InvestigatorList><Investigator ValidYN="Y"><LastName>Urban</LastName>
<ForeName>Philip</ForeName>
<Initials>P</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Morice</LastName>
<ForeName>Marie-Claude</ForeName>
<Initials>MC</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Abizaid</LastName>
<ForeName>Alexander</ForeName>
<Initials>A</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Meredith</LastName>
<ForeName>Ian T</ForeName>
<Initials>IT</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Pocock</LastName>
<ForeName>Stuart J</ForeName>
<Initials>SJ</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Carrié</LastName>
<ForeName>Didier</ForeName>
<Initials>D</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Naber</LastName>
<ForeName>Christoph</ForeName>
<Initials>C</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Greene</LastName>
<ForeName>Samantha</ForeName>
<Initials>S</Initials>
</Investigator>
<Investigator ValidYN="Y"><LastName>Stoll</LastName>
<ForeName>Hans-Peter</ForeName>
<Initials>HP</Initials>
</Investigator>
</InvestigatorList>
</MedlineCitation>
<PubmedData><History><PubMedPubDate PubStatus="received"><Year>2016</Year>
<Month>09</Month>
<Day>15</Day>
</PubMedPubDate>
<PubMedPubDate PubStatus="revised"><Year>2016</Year>
<Month>10</Month>
<Day>06</Day>
</PubMedPubDate>
<PubMedPubDate PubStatus="accepted"><Year>2016</Year>
<Month>10</Month>
<Day>07</Day>
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<PubMedPubDate PubStatus="pubmed"><Year>2016</Year>
<Month>11</Month>
<Day>4</Day>
<Hour>6</Hour>
<Minute>0</Minute>
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<PubMedPubDate PubStatus="medline"><Year>2017</Year>
<Month>7</Month>
<Day>14</Day>
<Hour>6</Hour>
<Minute>0</Minute>
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<PubMedPubDate PubStatus="entrez"><Year>2016</Year>
<Month>11</Month>
<Day>4</Day>
<Hour>6</Hour>
<Minute>0</Minute>
</PubMedPubDate>
</History>
<PublicationStatus>ppublish</PublicationStatus>
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<ArticleId IdType="pii">S0735-1097(16)36602-5</ArticleId>
<ArticleId IdType="doi">10.1016/j.jacc.2016.10.009</ArticleId>
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<affiliations><list><country><li>Allemagne</li>
<li>Australie</li>
<li>Brésil</li>
<li>Danemark</li>
<li>Espagne</li>
<li>France</li>
<li>Royaume-Uni</li>
<li>Singapour</li>
<li>Suisse</li>
<li>Thaïlande</li>
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<region><li>Angleterre</li>
<li>Berlin</li>
<li>District de Leipzig</li>
<li>Grand Londres</li>
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<li>Leipzig</li>
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</country>
<country name="Thaïlande"><noRegion><name sortKey="Tresukosol, Damras" sort="Tresukosol, Damras" uniqKey="Tresukosol D" first="Damras" last="Tresukosol">Damras Tresukosol</name>
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<country name="Royaume-Uni"><region name="Angleterre"><name sortKey="Pocock, Stuart J" sort="Pocock, Stuart J" uniqKey="Pocock S" first="Stuart J" last="Pocock">Stuart J. Pocock</name>
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<name sortKey="Byrne, Jonathan" sort="Byrne, Jonathan" uniqKey="Byrne J" first="Jonathan" last="Byrne">Jonathan Byrne</name>
<name sortKey="Gregson, John" sort="Gregson, John" uniqKey="Gregson J" first="John" last="Gregson">John Gregson</name>
<name sortKey="Menown, Ian B A" sort="Menown, Ian B A" uniqKey="Menown I" first="Ian B A" last="Menown">Ian B A. Menown</name>
<name sortKey="Redwood, Simon" sort="Redwood, Simon" uniqKey="Redwood S" first="Simon" last="Redwood">Simon Redwood</name>
<name sortKey="Talwar, Suneel" sort="Talwar, Suneel" uniqKey="Talwar S" first="Suneel" last="Talwar">Suneel Talwar</name>
</country>
<country name="Australie"><region name="Victoria (État)"><name sortKey="Meredith, Ian T" sort="Meredith, Ian T" uniqKey="Meredith I" first="Ian T" last="Meredith">Ian T. Meredith</name>
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<country name="Brésil"><region name="État de São Paulo"><name sortKey="Abizaid, Alexandre" sort="Abizaid, Alexandre" uniqKey="Abizaid A" first="Alexandre" last="Abizaid">Alexandre Abizaid</name>
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<country name="Singapour"><noRegion><name sortKey="Ong, Paul" sort="Ong, Paul" uniqKey="Ong P" first="Paul" last="Ong">Paul Ong</name>
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