A prospective, multicenter, real-world registry of coronary lithotripsy in calcified coronary arteries: the REPLICA-EPIC18 study

Background: Intravascular lithotripsy (IVL) has demonstrated effectiveness in the treatment of calcified lesions in selected patients with stable coronary disease. Objectives: The authors sought to assess the performance of coronary IVL in calcified coronary lesions in a real-life, all comers, setti...

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Autores: Rodríguez-Leor, Oriol, Cid-Álvarez, Ana Belén, López-Benito, María, Gonzalo, Nieves, Vilalta, Victoria, Diarte de Miguel, José Antonio, Fernández López, Leticia, Jurado-Román, Alfonso, Diego, Alejandro, Oteo, Juan Francisco, Cuellas, Carlos, Trillo, Ramiro, Travieso, Alendro, Alfonso, Fernando, Carrillo, Xavier, Vegas-Valle, José Miguel, Cortes-Villar, Carlos, Pascual, Isaac, Torre Hernández, José María de la |||0000-0003-4570-8902
Formato: artículo
Fecha de publicación:2024
País:España
Recursos:Universidad de Cantabria (UC)
Repositorio:UCrea Repositorio Abierto de la Universidad de Cantabria
Idioma:inglés
OAI Identifier:oai:repositorio.unican.es:10902/32750
Acesso em linha:https://hdl.handle.net/10902/32750
Access Level:acceso abierto
Palavra-chave:Acute coronary syndrome
Coronary artery calcification
Intravascular lithotripsy
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dc.title.none.fl_str_mv A prospective, multicenter, real-world registry of coronary lithotripsy in calcified coronary arteries: the REPLICA-EPIC18 study
title A prospective, multicenter, real-world registry of coronary lithotripsy in calcified coronary arteries: the REPLICA-EPIC18 study
spellingShingle A prospective, multicenter, real-world registry of coronary lithotripsy in calcified coronary arteries: the REPLICA-EPIC18 study
Rodríguez-Leor, Oriol
Acute coronary syndrome
Coronary artery calcification
Intravascular lithotripsy
title_short A prospective, multicenter, real-world registry of coronary lithotripsy in calcified coronary arteries: the REPLICA-EPIC18 study
title_full A prospective, multicenter, real-world registry of coronary lithotripsy in calcified coronary arteries: the REPLICA-EPIC18 study
title_fullStr A prospective, multicenter, real-world registry of coronary lithotripsy in calcified coronary arteries: the REPLICA-EPIC18 study
title_full_unstemmed A prospective, multicenter, real-world registry of coronary lithotripsy in calcified coronary arteries: the REPLICA-EPIC18 study
title_sort A prospective, multicenter, real-world registry of coronary lithotripsy in calcified coronary arteries: the REPLICA-EPIC18 study
dc.creator.none.fl_str_mv Rodríguez-Leor, Oriol
Cid-Álvarez, Ana Belén
López-Benito, María
Gonzalo, Nieves
Vilalta, Victoria
Diarte de Miguel, José Antonio
Fernández López, Leticia
Jurado-Román, Alfonso
Diego, Alejandro
Oteo, Juan Francisco
Cuellas, Carlos
Trillo, Ramiro
Travieso, Alendro
Alfonso, Fernando
Carrillo, Xavier
Vegas-Valle, José Miguel
Cortes-Villar, Carlos
Pascual, Isaac
Torre Hernández, José María de la |||0000-0003-4570-8902
author Rodríguez-Leor, Oriol
author_facet Rodríguez-Leor, Oriol
Cid-Álvarez, Ana Belén
López-Benito, María
Gonzalo, Nieves
Vilalta, Victoria
Diarte de Miguel, José Antonio
Fernández López, Leticia
Jurado-Román, Alfonso
Diego, Alejandro
Oteo, Juan Francisco
Cuellas, Carlos
Trillo, Ramiro
Travieso, Alendro
Alfonso, Fernando
Carrillo, Xavier
Vegas-Valle, José Miguel
Cortes-Villar, Carlos
Pascual, Isaac
Torre Hernández, José María de la |||0000-0003-4570-8902
author_role author
author2 Cid-Álvarez, Ana Belén
López-Benito, María
Gonzalo, Nieves
Vilalta, Victoria
Diarte de Miguel, José Antonio
Fernández López, Leticia
Jurado-Román, Alfonso
Diego, Alejandro
Oteo, Juan Francisco
Cuellas, Carlos
Trillo, Ramiro
Travieso, Alendro
Alfonso, Fernando
Carrillo, Xavier
Vegas-Valle, José Miguel
Cortes-Villar, Carlos
Pascual, Isaac
Torre Hernández, José María de la |||0000-0003-4570-8902
author2_role author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
dc.contributor.none.fl_str_mv Universidad de Cantabria
dc.subject.none.fl_str_mv Acute coronary syndrome
Coronary artery calcification
Intravascular lithotripsy
topic Acute coronary syndrome
Coronary artery calcification
Intravascular lithotripsy
description Background: Intravascular lithotripsy (IVL) has demonstrated effectiveness in the treatment of calcified lesions in selected patients with stable coronary disease. Objectives: The authors sought to assess the performance of coronary IVL in calcified coronary lesions in a real-life, all comers, setting. Methods: The REPLICA-EPIC18 study prospectively enrolled consecutive patients treated with IVL in 26 centers in Spain. An independent core laboratory performed the angiographic analysis and event adjudication. The primary effectiveness endpoint assessed procedural success (successful IVL delivery, final diameter stenosis <20%, and absence of in-hospital major adverse cardiovascular events [MACE]). The primary safety endpoint measured freedom from MACE at 30 days. A predefined substudy compared outcomes between acute coronary syndrome (ACS) and chronic coronary syndrome (CCS) patients. Results: A total of 426 patients (456 lesions) were included, 63% of the patients presenting with ACS. IVL delivery was successful in 99% of cases. Before IVL, 49% of lesions were considered undilatable. The primary effectiveness endpoint was achieved in 66% of patients, with similar rates among CCS patients (68%) and ACS patients (65%). Likewise, there were no significant differences in angiographic success after IVL between CCS and ACS patients. The rate of MACE at 30 days (primary safety endpoint) was 3% (1% in CCS and 5% in ACS patients [P = 0.073]). Conclusions: Coronary IVL proved to be a feasible and safe procedure in a "real-life" setting, effectively facilitating stent implantation in severely calcified lesions. Patients with ACS on admission showed similar angiographic success rates but showed a trend toward higher 30-day MACE compared with patients with CCS. (REPLICA-EPIC18 study [Registry of Coronary Lithotripsy in Spain]; NCT04298307)
publishDate 2024
dc.date.none.fl_str_mv 2024
2024-01-01
dc.type.none.fl_str_mv journal article
http://purl.org/coar/resource_type/c_6501
NA
http://purl.org/coar/version/c_be7fb7dd8ff6fe43
dc.type.openaire.fl_str_mv info:eu-repo/semantics/article
format article
dc.identifier.none.fl_str_mv https://hdl.handle.net/10902/32750
url https://hdl.handle.net/10902/32750
dc.language.none.fl_str_mv Inglés
eng
language_invalid_str_mv Inglés
language eng
dc.rights.none.fl_str_mv open access
http://purl.org/coar/access_right/c_abf2
Attribution 4.0 International
http://creativecommons.org/licenses/by/4.0/
dc.rights.openaire.fl_str_mv info:eu-repo/semantics/openAccess
rights_invalid_str_mv open access
http://purl.org/coar/access_right/c_abf2
Attribution 4.0 International
http://creativecommons.org/licenses/by/4.0/
eu_rights_str_mv openAccess
dc.publisher.none.fl_str_mv Elsevier
publisher.none.fl_str_mv Elsevier
dc.source.none.fl_str_mv JACC: Cardiovascular Interventions, 2024, 17(6), 756-767
reponame:UCrea Repositorio Abierto de la Universidad de Cantabria
instname:Universidad de Cantabria (UC)
instname_str Universidad de Cantabria (UC)
reponame_str UCrea Repositorio Abierto de la Universidad de Cantabria
collection UCrea Repositorio Abierto de la Universidad de Cantabria
repository.name.fl_str_mv
repository.mail.fl_str_mv
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spelling A prospective, multicenter, real-world registry of coronary lithotripsy in calcified coronary arteries: the REPLICA-EPIC18 studyRodríguez-Leor, OriolCid-Álvarez, Ana BelénLópez-Benito, MaríaGonzalo, NievesVilalta, VictoriaDiarte de Miguel, José AntonioFernández López, LeticiaJurado-Román, AlfonsoDiego, AlejandroOteo, Juan FranciscoCuellas, CarlosTrillo, RamiroTravieso, AlendroAlfonso, FernandoCarrillo, XavierVegas-Valle, José MiguelCortes-Villar, CarlosPascual, IsaacTorre Hernández, José María de la |||0000-0003-4570-8902Acute coronary syndromeCoronary artery calcificationIntravascular lithotripsyBackground: Intravascular lithotripsy (IVL) has demonstrated effectiveness in the treatment of calcified lesions in selected patients with stable coronary disease. Objectives: The authors sought to assess the performance of coronary IVL in calcified coronary lesions in a real-life, all comers, setting. Methods: The REPLICA-EPIC18 study prospectively enrolled consecutive patients treated with IVL in 26 centers in Spain. An independent core laboratory performed the angiographic analysis and event adjudication. The primary effectiveness endpoint assessed procedural success (successful IVL delivery, final diameter stenosis <20%, and absence of in-hospital major adverse cardiovascular events [MACE]). The primary safety endpoint measured freedom from MACE at 30 days. A predefined substudy compared outcomes between acute coronary syndrome (ACS) and chronic coronary syndrome (CCS) patients. Results: A total of 426 patients (456 lesions) were included, 63% of the patients presenting with ACS. IVL delivery was successful in 99% of cases. Before IVL, 49% of lesions were considered undilatable. The primary effectiveness endpoint was achieved in 66% of patients, with similar rates among CCS patients (68%) and ACS patients (65%). Likewise, there were no significant differences in angiographic success after IVL between CCS and ACS patients. The rate of MACE at 30 days (primary safety endpoint) was 3% (1% in CCS and 5% in ACS patients [P = 0.073]). Conclusions: Coronary IVL proved to be a feasible and safe procedure in a "real-life" setting, effectively facilitating stent implantation in severely calcified lesions. Patients with ACS on admission showed similar angiographic success rates but showed a trend toward higher 30-day MACE compared with patients with CCS. (REPLICA-EPIC18 study [Registry of Coronary Lithotripsy in Spain]; NCT04298307)FUNDING SUPPORT AND AUTHOR DISCLOSURES: The study sponsor, Fundación EPIC, has received an institutional research grant from Shockwave Medical (Santa Clara, California, USA) to cover the design and maintenance costs of the electronic case report form. Shockwave Medical has had no influence on the study design or protocol in any respect. Shockwave Medical was not involved in the conduct of the study, including inclusion, follow up, data collection, analysis, interpretation of results, drafting, and final approval of the protocol, nor in the genesis of this paper. Dr Rodriguez Leor has received speaker honoraria and consulting fees from Medtronic and World Medica. Dr Pérez de Prado has received speaker honoraria and consulting fees from iVascular, Boston Scien tific, Terumo, B. Braun, and Abbott Vascular. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose. ACKNOWLEDGMENTS: The authors express their sincere gratitude to Maria Angels Carmona and Juan Carlos Garmilla for their invaluable coordination in the execution of the study. Their dedicated efforts were instrumental in ensuring the smooth progress and successful completion of this research. Additionally, the authors extend their appreciation to all the investigators who played a crucial role in patient recruitment. Their commitment and contribution to the study are greatly acknowledged.ElsevierUniversidad de Cantabria20242024-01-01journal articlehttp://purl.org/coar/resource_type/c_6501NAhttp://purl.org/coar/version/c_be7fb7dd8ff6fe43info:eu-repo/semantics/articlehttps://hdl.handle.net/10902/32750JACC: Cardiovascular Interventions, 2024, 17(6), 756-767reponame:UCrea Repositorio Abierto de la Universidad de Cantabriainstname:Universidad de Cantabria (UC)Inglésengopen accesshttp://purl.org/coar/access_right/c_abf2Attribution 4.0 Internationalhttp://creativecommons.org/licenses/by/4.0/info:eu-repo/semantics/openAccessoai:repositorio.unican.es:10902/327502026-06-02T12:39:31Z
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