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XLIMus drug eluting stent: A randomIzed controlled Trial to assess endothelialization. The XLIMIT trial

BACKGROUND: Thin strut 3rd generation drug eluting stents offer the potential advantage over the previous generation of better technical performance and reduced neointimal proliferation parameters, which are linked to mid and late term device failure. AIM: To evaluate the performance of the Xlimus s...

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Autores principales: Testa, Luca, Pero, Gaetano, Bollati, Mario, Casenghi, Matteo, Popolo Rubbio, Antonio, Cuman, Magdalena, Moreno, Raul, Serra, Antoni, Gomez, Joan Antoni, Bedogni, Francesco
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Elsevier 2019
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6487315/
https://www.ncbi.nlm.nih.gov/pubmed/31061876
http://dx.doi.org/10.1016/j.ijcha.2019.100363
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author Testa, Luca
Pero, Gaetano
Bollati, Mario
Casenghi, Matteo
Popolo Rubbio, Antonio
Cuman, Magdalena
Moreno, Raul
Serra, Antoni
Gomez, Joan Antoni
Bedogni, Francesco
author_facet Testa, Luca
Pero, Gaetano
Bollati, Mario
Casenghi, Matteo
Popolo Rubbio, Antonio
Cuman, Magdalena
Moreno, Raul
Serra, Antoni
Gomez, Joan Antoni
Bedogni, Francesco
author_sort Testa, Luca
collection PubMed
description BACKGROUND: Thin strut 3rd generation drug eluting stents offer the potential advantage over the previous generation of better technical performance and reduced neointimal proliferation parameters, which are linked to mid and late term device failure. AIM: To evaluate the performance of the Xlimus sirolimus-eluting stent (SES) against the Synergy everolimus-eluting stent (EES) in terms of device reendothelialization in patients undergoing PCI for coronary artery disease (CAD). METHODS: XLIMIT is a multicenter randomized controlled trial targeting 180 patients requiring percutaneous coronary interventions (PCI). Patients will be treated with Xlimus SES or Synergy EES implantation and randomization will be performed in a 2:1 ratio. The primary endpoint will be the reendothelialization grade of the Xlimus stent in terms of strut coverage and neointimal hyperplasia volume as compared to Synergy. Secondary endpoints will be represented by clinical and procedural outcomes. The first patient was enrolled on February 2019. CONCLUSIONS: A clearer understanding of the endothelialization process of new generation DES could significantly impact the treatment with dual antiplatelet therapy in the future. Moreover, although not powered for clinical end-points, the XLIMIT trial will provide randomized data in a population with minimal exclusion criteria. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03745053. Registered on November 19, 2018.
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spelling pubmed-64873152019-05-06 XLIMus drug eluting stent: A randomIzed controlled Trial to assess endothelialization. The XLIMIT trial Testa, Luca Pero, Gaetano Bollati, Mario Casenghi, Matteo Popolo Rubbio, Antonio Cuman, Magdalena Moreno, Raul Serra, Antoni Gomez, Joan Antoni Bedogni, Francesco Int J Cardiol Heart Vasc Original Paper BACKGROUND: Thin strut 3rd generation drug eluting stents offer the potential advantage over the previous generation of better technical performance and reduced neointimal proliferation parameters, which are linked to mid and late term device failure. AIM: To evaluate the performance of the Xlimus sirolimus-eluting stent (SES) against the Synergy everolimus-eluting stent (EES) in terms of device reendothelialization in patients undergoing PCI for coronary artery disease (CAD). METHODS: XLIMIT is a multicenter randomized controlled trial targeting 180 patients requiring percutaneous coronary interventions (PCI). Patients will be treated with Xlimus SES or Synergy EES implantation and randomization will be performed in a 2:1 ratio. The primary endpoint will be the reendothelialization grade of the Xlimus stent in terms of strut coverage and neointimal hyperplasia volume as compared to Synergy. Secondary endpoints will be represented by clinical and procedural outcomes. The first patient was enrolled on February 2019. CONCLUSIONS: A clearer understanding of the endothelialization process of new generation DES could significantly impact the treatment with dual antiplatelet therapy in the future. Moreover, although not powered for clinical end-points, the XLIMIT trial will provide randomized data in a population with minimal exclusion criteria. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03745053. Registered on November 19, 2018. Elsevier 2019-04-28 /pmc/articles/PMC6487315/ /pubmed/31061876 http://dx.doi.org/10.1016/j.ijcha.2019.100363 Text en © 2019 The Authors http://creativecommons.org/licenses/by-nc-nd/4.0/ This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).
spellingShingle Original Paper
Testa, Luca
Pero, Gaetano
Bollati, Mario
Casenghi, Matteo
Popolo Rubbio, Antonio
Cuman, Magdalena
Moreno, Raul
Serra, Antoni
Gomez, Joan Antoni
Bedogni, Francesco
XLIMus drug eluting stent: A randomIzed controlled Trial to assess endothelialization. The XLIMIT trial
title XLIMus drug eluting stent: A randomIzed controlled Trial to assess endothelialization. The XLIMIT trial
title_full XLIMus drug eluting stent: A randomIzed controlled Trial to assess endothelialization. The XLIMIT trial
title_fullStr XLIMus drug eluting stent: A randomIzed controlled Trial to assess endothelialization. The XLIMIT trial
title_full_unstemmed XLIMus drug eluting stent: A randomIzed controlled Trial to assess endothelialization. The XLIMIT trial
title_short XLIMus drug eluting stent: A randomIzed controlled Trial to assess endothelialization. The XLIMIT trial
title_sort xlimus drug eluting stent: a randomized controlled trial to assess endothelialization. the xlimit trial
topic Original Paper
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6487315/
https://www.ncbi.nlm.nih.gov/pubmed/31061876
http://dx.doi.org/10.1016/j.ijcha.2019.100363
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