TY - JOUR
T1 - Renal function and risk stratification of patients with embolic stroke of undetermined source
AU - Ntaios, George
AU - Lip, Gregory Y.H.
AU - Lambrou, Dimitris
AU - Michel, Patrik
AU - Perlepe, Kalliopi
AU - Eskandari, Ashraf
AU - Nannoni, Stefania
AU - Sirimarco, Gaia
AU - Strambo, Davide
AU - Vemmos, Konstantinos
AU - Koroboki, Eleni
AU - Manios, Efstathios
AU - Vemmou, Anastasia
AU - Rodríguez-Campello, Ana
AU - Cuadrado-Godia, Elisa
AU - Roquer, Jaume
AU - Arnao, Valentina
AU - Caso, Valeria
AU - Paciaroni, Maurizio
AU - Diez-Tejedor, Exuperio
AU - Fuentes, Blanca
AU - Pardo, Jorge Rodríguez
AU - Arauz, Antonio
AU - Ameriso, Sebastian F.
AU - Pertierra, Lucía
AU - Gómez-Schneider, Maia
AU - Hawkes, Maximiliano A.
AU - Bandini, Fabio
AU - Cano, Beatriz Chavarria
AU - Mohedano, Ana Maria Iglesias
AU - Pastor, Andrés García
AU - Gil-Núñez, Antonio
AU - Putaala, Jukka
AU - Tatlisumak, Turgut
AU - Barboza, Miguel A.
AU - Karagkiozi, Efstathia
AU - Makaritsis, Konstantinos
AU - Papavasileiou, Vasileios
N1 - Funding Information:
Dr Diez-Tejedor: Investigator in the NAVIGATE ESUS and RE-SPECT ESUS trials. Speaker’s honorary: Bayer. Dr Fuentes: Investigator in the NAVIGATE ESUS and RE-SPECT ESUS trials. Speaker’s honorary: Daichi-Sankyo, Bayer. Dr Rodríguez Pardo: Investigator in the NAVIGATE ESUS and RE-SPECT ESUS trials. Speaker’s honorary: Bayer. Dr Bandini: Speaker fees from Daichii Sankyo and Bayer. Dr Mohedano: participation in the NAVIGATE ESUS and RE-SPECT ESUS trials. Dr García Pastor: participation in the NAVIGATE ESUS and RE-SPECT ESUS trials. Dr Gil-Núñez: participation in the NAVIGATE ESUS and RE-SPECT ESUS trials. Dr Putaala: Speaker Honorary: Bayer, BMS-Pfizer, Boehringer Ingelheim, Abbott; Advisory Board: Bayer, BMS-Pfizer, Boehringer Ingelheim, MSD; Research grant: BMS-Pfizer, St. Jude Medical. Dr Tatlisumak: Member of the Steering Committee of the NAVIGATE ESUS trial. Advisory board membership: Bayer, Sanofi Aventis, Lumosa, Boehringer Ingelheim, Pfizer. Research contracts with Boehringer Ingelheim, Bayer, Portola, Pfizer, Sanofi Aventis, BrainsGate. Dr Barboza: Research support from Pfizer and Boehringer Ingelheim. Speaker fees from Abbott Laboratories and Bayer Pharmaceuticals. The other authors report no conflicts.
Funding Information:
Dr Ntaios: member of the Steering Committee of the NAVIGATE ESUS trial. Speaker fees/Advisory Boards/Research support from Amgen; Bayer; BMS/Pfizer; Boehringer Ingelheim; Elpen; European Union; Galenica; Sanofi; Winmedica. No fees are directly received personally. Dr Lip: Consultant for Bayer/Janssen, BMS/Pfizer, Medtronic, Boehringer Ingelheim, Novartis, Verseon and Daiichi Sankyo. Speaker for Bayer, BMS/Pfizer, Medtronic, Boehringer Ingelheim, and Daiichi Sankyo. No fees are directly received personally. Dr Michel has received research grant from the Swiss Heart foundation and BMS/Pfizer, has received speaker fees from Medtronic and Amgen, and was an advisory board member for Medtronic, Amgen, Pfizer, and BMS. Dr Sirimarco: has received research grant from the Swiss Heart Foundation and BMS/Pfizer, has served on scientific advisory boards for Amgen and Daiichi Sankyo, and has received congress travel support from Bayer and Shire. Dr Koroboki has received speaker honoraria from Amgen and Pfizer, Wan an advisory board member for Pfizer, and received travel grant from Bayer. Dr Campello: Investigator at the NAVIGATE ESUS (Rivaroxaban Versus Aspirin in Secondary Prevention of Stroke and Prevention of Systemic Embolism in Patients With Recent Embolic Stroke of Undetermined Source) and RE-SPECT ESUS trials. Dr Caso has received research grant from Boehringer Ingelheim, was at the speakers’ bureau for Boehringer Ingelheim, Daiichi Sankyo, BMS/Pfizer, and Bayer (all paid to ARS Umbria), and was an advisory board member for Boehringer Ingelheim. Dr Paciaroni was at the speaker bureau for Bayer, Boehringer Ingelheim, Pfizer, BMS, Medtronic, Aspen, Sanofi Aventis, and Daiichi Sankyo.
Publisher Copyright:
© 2018 American Heart Association, Inc.
PY - 2018
Y1 - 2018
N2 - Background and Purpose-We aimed to assess if renal function can aid in risk stratification for ischemic stroke or transient ischemic attack (TIA) recurrence and death in patients with embolic stroke of undetermined source (ESUS). Methods-We pooled 12 ESUS datasets from Europe and America. Renal function was evaluated using the estimated glomerular filtration rate (eGFR) and analyzed in continuous, binary, and categorical way. Cox-regression analyses assessed if renal function was independently associated with the risk for ischemic stroke/TIA recurrence and death. The Kaplan-Meier product limit method estimated the cumulative probability of ischemic stroke/TIA recurrence and death. Results-In 1530 patients with ESUS followed for 3260 patient-years, there were 237 recurrences (15.9%) and 201 deaths (13.4%), corresponding to 7.3 ischemic stroke/TIA recurrences and 5.6 deaths per 100 patient-years, respectively. Renal function was not associated with the risk for ischemic stroke/TIA recurrence when forced into the final multivariate model, regardless if it was analyzed as continuous (hazard ratio, 1.00; 95% CI, 0.99.1.00 for every 1 mL/min), binary (hazard ratio, 1.27; 95% CI, 0.87. 1.73) or categorical covariate (likelihood-ratio test 2.59, P=0.63 for stroke recurrence). The probability of ischemic stroke/TIA recurrence across stages of renal function was 11.9% for eGFR ≥90, 16.6% for eGFR 60.89, 21.7% for eGFR 45.59, 19.2% for eGFR 30.44, and 24.9% for eGFR <30 (likelihood-ratio test 2.59, P=0.63). The results were similar for the outcome of death. Conclusions-The present study is the largest pooled individual patient-level ESUS dataset, and does not provide evidence that renal function can be used to stratify the risk of ischemic stroke/TIA recurrence or death in patients with ESUS.
AB - Background and Purpose-We aimed to assess if renal function can aid in risk stratification for ischemic stroke or transient ischemic attack (TIA) recurrence and death in patients with embolic stroke of undetermined source (ESUS). Methods-We pooled 12 ESUS datasets from Europe and America. Renal function was evaluated using the estimated glomerular filtration rate (eGFR) and analyzed in continuous, binary, and categorical way. Cox-regression analyses assessed if renal function was independently associated with the risk for ischemic stroke/TIA recurrence and death. The Kaplan-Meier product limit method estimated the cumulative probability of ischemic stroke/TIA recurrence and death. Results-In 1530 patients with ESUS followed for 3260 patient-years, there were 237 recurrences (15.9%) and 201 deaths (13.4%), corresponding to 7.3 ischemic stroke/TIA recurrences and 5.6 deaths per 100 patient-years, respectively. Renal function was not associated with the risk for ischemic stroke/TIA recurrence when forced into the final multivariate model, regardless if it was analyzed as continuous (hazard ratio, 1.00; 95% CI, 0.99.1.00 for every 1 mL/min), binary (hazard ratio, 1.27; 95% CI, 0.87. 1.73) or categorical covariate (likelihood-ratio test 2.59, P=0.63 for stroke recurrence). The probability of ischemic stroke/TIA recurrence across stages of renal function was 11.9% for eGFR ≥90, 16.6% for eGFR 60.89, 21.7% for eGFR 45.59, 19.2% for eGFR 30.44, and 24.9% for eGFR <30 (likelihood-ratio test 2.59, P=0.63). The results were similar for the outcome of death. Conclusions-The present study is the largest pooled individual patient-level ESUS dataset, and does not provide evidence that renal function can be used to stratify the risk of ischemic stroke/TIA recurrence or death in patients with ESUS.
KW - Brain ischemia
KW - Glomerular filtration rate
KW - Probability
KW - Recurrence
KW - Stroke
UR - http://www.scopus.com/inward/record.url?scp=85058916569&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85058916569&partnerID=8YFLogxK
U2 - 10.1161/STROKEAHA.118.023281
DO - 10.1161/STROKEAHA.118.023281
M3 - Article
C2 - 30571398
AN - SCOPUS:85058916569
SN - 0039-2499
VL - 49
SP - 2904
EP - 2909
JO - Stroke; a journal of cerebral circulation
JF - Stroke; a journal of cerebral circulation
IS - 12
ER -