A Prospective, Multicenter, Real-World Registry of Coronary Lithotripsy in Calcified Coronary Arteries : The REPLICA-EPIC18 Study
Copyright © 2024 The Authors. Published by Elsevier Inc. All rights reserved..
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).
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2024 |
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| Erschienen: |
2024 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:17 |
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| Enthalten in: |
JACC. Cardiovascular interventions - 17(2024), 6 vom: 25. März, Seite 756-767 |
| Sprache: |
Englisch |
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| Links: |
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| Themen: |
Acute coronary syndrome |
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| Anmerkungen: |
Date Completed 29.03.2024 Date Revised 29.03.2024 published: Print-Electronic ClinicalTrials.gov: NCT04298307 Citation Status MEDLINE |
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| doi: |
10.1016/j.jcin.2023.12.018 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
NLM368759369 |
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| 100 | 1 | |a Rodriguez-Leor, Oriol |e verfasserin |4 aut | |
| 245 | 1 | 2 | |a A Prospective, Multicenter, Real-World Registry of Coronary Lithotripsy in Calcified Coronary Arteries |b The REPLICA-EPIC18 Study |
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| 500 | |a Date Completed 29.03.2024 | ||
| 500 | |a Date Revised 29.03.2024 | ||
| 500 | |a published: Print-Electronic | ||
| 500 | |a ClinicalTrials.gov: NCT04298307 | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a Copyright © 2024 The Authors. Published by Elsevier Inc. All rights reserved. | ||
| 520 | |a BACKGROUND: Intravascular lithotripsy (IVL) has demonstrated effectiveness in the treatment of calcified lesions in selected patients with stable coronary disease | ||
| 520 | |a OBJECTIVES: The authors sought to assess the performance of coronary IVL in calcified coronary lesions in a real-life, all comers, setting | ||
| 520 | |a 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 | ||
| 520 | |a 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]) | ||
| 520 | |a 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) | ||
| 650 | 4 | |a Multicenter Study | |
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a acute coronary syndrome | |
| 650 | 4 | |a coronary artery calcification | |
| 650 | 4 | |a intravascular lithotripsy | |
| 700 | 1 | |a Cid-Alvarez, Ana Belen |e verfasserin |4 aut | |
| 700 | 1 | |a Lopez-Benito, Maria |e verfasserin |4 aut | |
| 700 | 1 | |a Gonzalo, Nieves |e verfasserin |4 aut | |
| 700 | 1 | |a Vilalta, Victoria |e verfasserin |4 aut | |
| 700 | 1 | |a Diarte de Miguel, Jose Antonio |e verfasserin |4 aut | |
| 700 | 1 | |a López, Leticia Fernandez |e verfasserin |4 aut | |
| 700 | 1 | |a Jurado-Roman, Alfonso |e verfasserin |4 aut | |
| 700 | 1 | |a Diego, Alejandro |e verfasserin |4 aut | |
| 700 | 1 | |a Oteo, Juan Francisco |e verfasserin |4 aut | |
| 700 | 1 | |a Cuellas, Carlos |e verfasserin |4 aut | |
| 700 | 1 | |a Trillo, Ramiro |e verfasserin |4 aut | |
| 700 | 1 | |a Travieso, Alejandro |e verfasserin |4 aut | |
| 700 | 1 | |a Alfonso, Fernando |e verfasserin |4 aut | |
| 700 | 1 | |a Carrillo, Xavier |e verfasserin |4 aut | |
| 700 | 1 | |a Vegas-Valle, José Miguel |e verfasserin |4 aut | |
| 700 | 1 | |a Cortes-Villar, Carlos |e verfasserin |4 aut | |
| 700 | 1 | |a Pascual, Isaac |e verfasserin |4 aut | |
| 700 | 1 | |a Muñoz Camacho, Juan Francisco |e verfasserin |4 aut | |
| 700 | 1 | |a Flores, Xacobe |e verfasserin |4 aut | |
| 700 | 1 | |a Vera-Vera, Silvio |e verfasserin |4 aut | |
| 700 | 1 | |a Moreu, Jose |e verfasserin |4 aut | |
| 700 | 1 | |a Barreira de Sousa, Gilles |e verfasserin |4 aut | |
| 700 | 1 | |a Martí, David |e verfasserin |4 aut | |
| 700 | 1 | |a Jimenez-Mazuecos, Jesus |e verfasserin |4 aut | |
| 700 | 1 | |a Fuertes, Monica |e verfasserin |4 aut | |
| 700 | 1 | |a Ocaranza, Raymundo |e verfasserin |4 aut | |
| 700 | 1 | |a de la Torre Hernandez, Jose Maria |e verfasserin |4 aut | |
| 700 | 1 | |a Lozano, Fernando |e verfasserin |4 aut | |
| 700 | 1 | |a Solana Martinez, Santiago G |e verfasserin |4 aut | |
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| 700 | 0 | |a REPLICA-EPIC18 Investigators |e verfasserin |4 aut | |
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| 700 | 1 | |a Sánchez, Javier Jimeno |e investigator |4 oth | |
| 700 | 1 | |a Moreiras, Javier Martin |e investigator |4 oth | |
| 700 | 1 | |a Rivero, Borja |e investigator |4 oth | |
| 700 | 1 | |a Nofrerias, Eduard Fernandez |e investigator |4 oth | |
| 700 | 1 | |a Lozano, Iñigo |e investigator |4 oth | |
| 700 | 1 | |a Roldan, Juan |e investigator |4 oth | |
| 700 | 1 | |a García-Touchard, Arturo |e investigator |4 oth | |
| 700 | 1 | |a Serrano, Carlos Arellano |e investigator |4 oth | |
| 700 | 1 | |a Rivero, Fernando |e investigator |4 oth | |
| 700 | 1 | |a Avanzas, Pablo |e investigator |4 oth | |
| 700 | 1 | |a Almendarez, Marcel |e investigator |4 oth | |
| 700 | 1 | |a Santos, Ramon Calviño |e investigator |4 oth | |
| 700 | 1 | |a Esteban, Pablo Piñon |e investigator |4 oth | |
| 700 | 1 | |a Yuskova, Maria |e investigator |4 oth | |
| 700 | 1 | |a Redondo, Alfredo |e investigator |4 oth | |
| 700 | 1 | |a D'Ascoli, Giulio |e investigator |4 oth | |
| 700 | 1 | |a Mas, Adria Tramullas |e investigator |4 oth | |
| 700 | 1 | |a Portero-Portaz, Juan J |e investigator |4 oth | |
| 700 | 1 | |a García-Camarero, Tamara |e investigator |4 oth | |
| 700 | 1 | |a Mohandes, Mohsen |e investigator |4 oth | |
| 700 | 1 | |a Rubio, Tomas Canton |e investigator |4 oth | |
| 700 | 1 | |a Suarez, Alfonso |e investigator |4 oth | |
| 700 | 1 | |a Bayón, Jeremías |e investigator |4 oth | |
| 700 | 1 | |a Oliveira, Julio Peral |e investigator |4 oth | |
| 700 | 1 | |a Salgado, Carlos Alonso |e investigator |4 oth | |
| 700 | 1 | |a Gómez-Hospital, Joan Antoni |e investigator |4 oth | |
| 700 | 1 | |a González, Reyes |e investigator |4 oth | |
| 700 | 1 | |a López-Minguez, José Ramón |e investigator |4 oth | |
| 700 | 1 | |a Palazuelos, Jorge |e investigator |4 oth | |
| 700 | 1 | |a Sliwinski, Frank |e investigator |4 oth | |
| 700 | 1 | |a Fernandez, Guillermo Bastos |e investigator |4 oth | |
| 700 | 1 | |a De Miguel Castro, Antonio |e investigator |4 oth | |
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