Retrospective Study
Copyright ©The Author(s) 2015. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Transplant. Dec 24, 2015; 5(4): 310-319
Published online Dec 24, 2015. doi: 10.5500/wjt.v5.i4.310
Twelve-month efficacy and safety of the conversion to everolimus in maintenance heart transplant recipients
Nicolás Manito, Juan F Delgado, María G Crespo-Leiro, José María Arizón, Javier Segovia, Francisco González-Vílchez, Sònia Mirabet, Ernesto Lage, Domingo Pascual-Figal, Beatriz Díaz, Jesús Palomo, Gregorio Rábago, Marisa Sanz, Teresa Blasco, Eulàlia Roig
Nicolás Manito, Heart Failure and Transplant Unit, Department of Cardiology, Hospital de Bellvitge, 08907 Barcelona, Spain
Juan F Delgado, Heart Failure and Transplant Unit, Department of Cardiology, Hospital 12 de Octubre, 28041 Madrid, Spain
María G Crespo-Leiro, Department of Cardiology, Complejo Hospitalario Universitario A Coruña, 15006 A Corunna, Spain
José María Arizón, Department of Cardiology, Hospital Universitario Reina Sofía, 14004 Córdoba, Spain
Javier Segovia, Heart Failure, Transplant and Pulmonary Hypertension Unit, Hospital Universitario Puerta de Hierro, 28222 Madrid, Spain
Francisco González-Vílchez, Department of Cardiology, Hospital Universitario Marqués de Valdecilla, 39008 Santander, Spain
Sònia Mirabet, Eulàlia Roig, Department of Cardiology, Hospital de la Santa Creu i Sant Pau, 08025 Barcelona, Spain
Ernesto Lage, Department of Cardiology, Hospital Universitario Virgen del Rocío, 41013 Sevilla, Spain
Domingo Pascual-Figal, Department of Cardiology, Hospital Virgen de la Arrixaca, 30120 Murcia, Spain
Beatriz Díaz, Department of Cardiology, Hospital Universitario Central de Asturias, 33006 Oviedo, Spain
Jesús Palomo, Department of Cardiology, Hospital General Universitario Gregorio Marañón, 28009 Madrid, Spain
Gregorio Rábago, Department of Cardiovascular Surgery, Clínica Universitaria de Navarra, 31008 Pamplona, Spain
Marisa Sanz, Teresa Blasco, Department of Cardiology, Hospital Miguel Servet, 50009 Zaragoza, Spain
Eulàlia Roig, Department of Cardiology, Hospital Clínic i Provincial, 08036 Barcelona, Spain
Author contributions: Manito N participated in the design of the study, in the performance of the research, in data analysis and in the writing of the paper; Delgado JF, Crespo-Leiro MG, Arizón JM, Segovia J, González-Vílchez F, Mirabet S, Lage E, Pascual-Figal D, Díaz B, Palomo J, Rábago G, Sanz M, Blasco T and Roig E participated in the performance of the research and critically reviewed the paper.
Supported by Novartis Pharma Spain.
Institutional review board statement: The study was reviewed and approved by the ethics committee at Vall d’Hebron Hospital of Barcelona (Spain).
Informed consent statement: All study participants provided informed written consent prior to study enrollment. Informed consent document was approved by the ethics committee at Vall d’Hebron Hospital of Barcelona (Spain).
Conflict-of-interest statement: Dr. Manito, Dra. Crespo-Leiro, Dr. Arizón, Dr. Segovia, Dra. Díaz, Dr. Rábago, Dra. Sanz, Dra. Blasco and Dra. Roig report grants from Novartis, during the conduct of the study. Dr. Delgado reports grants from Novartis Spain, during the conduct of the study. Dr. González-Vílchez reports grants from Novartis, during the conduct of the study; personal fees from Novartis, outside the submitted work. Dra. Mirabet reports grants from Novartis Spain, during the conduct of the study. Dr. Lage reports grants from Novartis during the conduct of the study. Dr. Pascual-Figal reports grants from Novartis, during the conduct of the study; grants and non-financial support from Roche Pharma, outside the submitted work. Dr. Palomo reports grants from Novartis, during the conduct of the study; personal fees from Novartis outside the submitted work.
Data sharing statement: Technical appendix, statistical code, and dataset available from the corresponding author at nml@csub.scs.es.
Open-Access: This article is an open-access article which was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/
Correspondence to: Nicolás Manito, MD, Heart Failure and Transplant Unit, Department of Cardiology, Hospital de Bellvitge, C/Feixa Llarga s/n, 08907 Barcelona, Spain. nml@csub.scs.es
Telephone: +34-93-2607600 Fax: +34-93-2607533
Received: April 28, 2015
Peer-review started: May 7, 2015
First decision: June 24, 2015
Revised: September 4, 2015
Accepted: October 12, 2015
Article in press: October 13, 2015
Published online: December 24, 2015
Processing time: 238 Days and 11.6 Hours
Core Tip

Core tip: This study is one of the largest multicentre Spanish series of heart transplant recipients converted to everolimus (EVL) reported to date. The results have helped to confirm the efficacy and safety profile of the drug under conditions of routine clinical practice. In the study, conversion to EVL in maintenance phase heart transplant recipients allowed a significant reduction in calcineurin inhibitor treatment with improved kidney function in patients with nephrotoxicity, after one year. Results regarding rejection episodes and EVL discontinuation, suggest that each patient should be individually evaluated for conversion to EVL based on their clinical profile and transplantation evolution.