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DC Field | Value | Language |
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dc.contributor.author | Urban P. | en |
dc.contributor.author | Garot P. | en |
dc.contributor.author | Berland J. | en |
dc.contributor.author | Abdellaoui M. | en |
dc.contributor.author | Morice M.-C. | en |
dc.contributor.author | Abizaid A. | en |
dc.contributor.author | Greene S. | en |
dc.contributor.author | Pocock S. | en |
dc.contributor.author | Meredith I. | en |
dc.contributor.author | Lipiecki J. | en |
dc.contributor.author | Carrie D. | en |
dc.date.accessioned | 2021-05-14T13:49:22Z | en |
dc.date.available | 2021-05-14T13:49:22Z | en |
dc.date.copyright | 2016 | en |
dc.date.created | 20160304 | en |
dc.date.issued | 2016-03-16 | en |
dc.identifier.citation | Archives of Cardiovascular Diseases Supplements. Conference: 26es Journees Europeennes de la Societe Francaise de Cardiologie. Paris France. Conference Publication: (var.pagings). 8 (1 SUPPL. 1) (pp 2-3), 2016. Date of Publication: January 2016. | en |
dc.identifier.issn | 1878-6480 | en |
dc.identifier.uri | https://repository.monashhealth.org/monashhealthjspui/handle/1/40411 | en |
dc.description.abstract | Background A sizeable proportion of patients treated with PCI are unable to take dual antiplatelet therapy (DAPT) for the guideline-recommended time period of 6-12 months. Optimal treatment of pts at high bleeding risk thus remains uncertain. The BioFreedomTM DCS (Biosensors, Europe SA, Morges, Switzerland) is polymer- and carrier-free, releases Biolimus A9 into the vessel wall over a period of 4 weeks, and then technically becomes a BMS. Methods 2,466 pts at high bleeding risk from 68 centers in Europe, Asia, and Canada were enrolled over an 18 months period in a doubleblinded randomized 1:1 comparison of the GazelleTM BMS vs. the BioFreedom DCS (both Biosensors, Morges, CH) with a 1 month course of DAPT only in both arms. At 1 year, the primary endpoints are: safety: a composite of cardiovascular death, MI and stent thrombosis, and efficacy: the rate of ci-TLR. Current results In the trial population, the most frequently used inclusion criteria were: advanced age (64%), need for long term oral anticoagulation (36%), anemia, recent bleeding or transfusion (20%), renal insufficiency (18%), planned surgery (15%) and concomitant cancer (9%). When compared to those included in 'all-comer' trials, pts were markedly older (75 years) and had more co-morbidiites (diabetes 33%, atrial fibrillation 33%, peripheral vascular disease 15%, heart failure 13%, prior stroke 9% and COPD 11%) 1.5 lesions/pts were treated and 1.7 stents/pts were implanted for a total stent length of 32mm/patient. Technical procedure success was 95%. 71% of pts were discharged on DAPT alone, 27% of DAPT+oral anticoagulation and 2% on a single antiplatelet agent + oral anticoagulation. Conclusion The trial focuses on a never previously studied high bleeding risk population characterized by advanced age and more comorbid conditions. It is the 1st evaluation of a DCS with clinical endpoints and comprises the shortest ever DAPT course with an active stent to be evaluated for both safety and efficacy. | en |
dc.language | en | en |
dc.language | English | en |
dc.publisher | Elsevier Masson SAS | en |
dc.subject | *risk | en |
dc.subject | anticoagulation | en |
dc.subject | drug eluting coronary stent | en |
dc.subject | biosensor | en |
dc.subject | population | en |
dc.subject | safety | en |
dc.subject | stent | en |
dc.subject | Europe | en |
dc.subject | gazelle | en |
dc.subject | procedures | en |
dc.subject | Canada | en |
dc.subject | arm | en |
dc.subject | Asia | en |
dc.subject | peripheral vascular disease | en |
dc.subject | blood vessel wall | en |
dc.subject | atrial fibrillation | en |
dc.subject | diabetes mellitus | en |
dc.subject | surgery | en |
dc.subject | transfusion | en |
dc.subject | anemia | en |
dc.subject | Switzerland | en |
dc.subject | kidney failure | en |
dc.subject | stent thrombosis | en |
dc.subject | neoplasm | en |
dc.subject | heart failure | en |
dc.subject | cerebrovascular accident | en |
dc.subject | death | en |
dc.subject | therapy | en |
dc.subject | umirolimus | en |
dc.subject | antithrombocytic agent | en |
dc.subject | *polymer | en |
dc.subject | *drug eluting stent | en |
dc.subject | *patient | en |
dc.subject | *human | en |
dc.subject | *bleeding | en |
dc.title | The leaders free trial: A double blind randomized comparison of a BMS and a polymer-free Drug Coated Stent (DCS) in 2,466 patients at high bleeding risk and treated with one month DAPT only. | en |
dc.type | Conference Abstract | en |
local.date.conferencestart | 2016-01-13 | en |
dc.identifier.source | 72208252 | en |
dc.identifier.institution | (Lipiecki) Pole Sante Republique, Clermont-Ferrand, France (Carrie) CHU Toulouse, Rangueil, Toulouse, France (Garot) Institut Cardiovasculaire Paris Sud, Quincy-Sous-Senart, France (Berland) Clinique St Hilaire, Rouen, France (Abdellaoui) GH Mutualiste Grenoble, Grenoble, France (Morice) CERC, Massy, France (Abizaid) Instituto Dante Pazzanese De Cardiologia, Sao Paulo, Brazil (Meredith) Monash Medical Centre, Clayton, Australia (Greene) Biosensors, Morges, Switzerland (Pocock) London School of Hygiene and Tropical Medicine, Londres, United Kingdom (Urban) Hopital De La Tour, Geneve, Switzerland | en |
dc.description.address | P. Garot, Institut Cardiovasculaire Paris Sud, Quincy-Sous-Senart, France. E-mail: p.garot@icps.com.fr | en |
dc.subject.keyword | safety | en |
dc.subject.keyword | stent | en |
dc.subject.keyword | Europe | en |
dc.subject.keyword | gazelle | en |
dc.subject.keyword | procedures | en |
dc.subject.keyword | Canada | en |
dc.subject.keyword | arm | en |
dc.subject.keyword | Asia | en |
dc.subject.keyword | peripheral vascular disease | en |
dc.subject.keyword | blood vessel wall | en |
dc.subject.keyword | atrial fibrillation | en |
dc.subject.keyword | diabetes mellitus | en |
dc.subject.keyword | surgery | en |
dc.subject.keyword | transfusion | en |
dc.subject.keyword | anemia | en |
dc.subject.keyword | Switzerland | en |
dc.subject.keyword | kidney failure | en |
dc.subject.keyword | stent thrombosis | en |
dc.subject.keyword | neoplasm | en |
dc.subject.keyword | heart failure | en |
dc.subject.keyword | cerebrovascular accident | en |
dc.subject.keyword | *risk | en |
dc.subject.keyword | therapy | en |
dc.subject.keyword | *bleeding | en |
dc.subject.keyword | *human | en |
dc.subject.keyword | *patient | en |
dc.subject.keyword | death | en |
dc.subject.keyword | anticoagulation | en |
dc.subject.keyword | drug eluting coronary stent | en |
dc.subject.keyword | biosensor | en |
dc.subject.keyword | population | en |
dc.subject.keyword | *drug eluting stent | en |
dc.relation.libraryurl | LibKey Link | en |
dc.description.publicationstatus | CONFERENCE ABSTRACT | en |
local.date.conferenceend | 2016-01-16 | en |
dc.rights.statement | Copyright 2016 Elsevier B.V., All rights reserved. | en |
dc.identifier.authoremail | Garot P.; p.garot@icps.com.fr | en |
dc.identifier.affiliationext | (Lipiecki) Pole Sante Republique, Clermont-Ferrand, France | - |
dc.identifier.affiliationext | (Carrie) CHU Toulouse, Rangueil, Toulouse, France | - |
dc.identifier.affiliationext | (Garot) Institut Cardiovasculaire Paris Sud, Quincy-Sous-Senart, France | - |
dc.identifier.affiliationext | (Berland) Clinique St Hilaire, Rouen, France | - |
dc.identifier.affiliationext | (Abdellaoui) GH Mutualiste Grenoble, Grenoble, France | - |
dc.identifier.affiliationext | (Morice) CERC, Massy, France | - |
dc.identifier.affiliationext | (Abizaid) Instituto Dante Pazzanese De Cardiologia, Sao Paulo, Brazil | - |
dc.identifier.affiliationext | (Greene) Biosensors, Morges, Switzerland | - |
dc.identifier.affiliationext | (Pocock) London School of Hygiene and Tropical Medicine, Londres, United Kingdom | - |
dc.identifier.affiliationext | (Urban) Hopital De La Tour, Geneve, Switzerland | - |
dc.identifier.affiliationmh | (Meredith) Monash Medical Centre, Clayton, Australia | - |
item.openairetype | Conference Abstract | - |
item.openairecristype | http://purl.org/coar/resource_type/c_18cf | - |
item.grantfulltext | none | - |
item.cerifentitytype | Publications | - |
item.fulltext | No Fulltext | - |
crisitem.author.dept | Cardiology (MonashHeart & Victorian Heart Institute) | - |
Appears in Collections: | Conferences |
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