Recurrent Stroke With Rivaroxaban Compared With Aspirin
According to Predictors of Atrial Fibrillation Secondary
Analysis of the NAVIGATE ESUS Randomized Clinical Trial

J 2019

Recurrent Stroke With Rivaroxaban Compared With Aspirin According to Predictors of Atrial Fibrillation Secondary Analysis of the NAVIGATE ESUS Randomized Clinical Trial

HEALEY, J. S., D. J. GLADSTONE, B. SWAMINATHAN, J. ECKSTEIN, H. MUNDL et. al.

Základní údaje

Originální název

Recurrent Stroke With Rivaroxaban Compared With Aspirin According to Predictors of Atrial Fibrillation Secondary Analysis of the NAVIGATE ESUS Randomized Clinical Trial

Autoři

HEALEY, J. S. (124 Kanada, garant), D. J. GLADSTONE (124 Kanada), B. SWAMINATHAN (124 Kanada), J. ECKSTEIN (756 Švýcarsko), H. MUNDL (276 Německo), A. E. EPSTEIN (840 Spojené státy), K. G. HAEUSLER (276 Německo), Robert MIKULÍK (203 Česká republika, domácí), S. E. KASNER (840 Spojené státy), D. TONI (380 Itálie), A. ARAUZ (484 Mexiko), G. NTAIOS (300 Řecko), G. J. HANKEY (36 Austrálie), K. PERERA (124 Kanada), J. PAGOLA (124 Kanada), A. SHUAIB (124 Kanada), H. LUTSEP (840 Spojené státy), X. M. YANG (156 Čína), S. UCHIYAMA (392 Japonsko), M. ENDRES (276 Německo), S. B. COUTTS (124 Kanada), M. KARLINSKI (616 Polsko), A. CZLONKOWSKA (616 Polsko), C. A. MOLINA (724 Španělsko), G. SANTO (620 Portugalsko), S. D. BERKOWITZ (840 Spojené státy), R. G. HART (124 Kanada) a S. J. CONNOLLY (124 Kanada)

Vydání

JAMA neurology, Chicago, IL, American Medical Association, 2019, 2168-6149

Další údaje

Jazyk

angličtina

Typ výsledku

Článek v odborném periodiku

Obor

30210 Clinical neurology

Stát vydavatele

Spojené státy

Utajení

není předmětem státního či obchodního tajemství

Odkazy

URL

Impakt faktor

Impact factor: 13.608

Kód RIV

RIV/00216224:14110/19:00113269

Organizační jednotka

Lékařská fakulta

DOI

http://dx.doi.org/10.1001/jamaneurol.2019.0617

UT WoS

000483154300006

Klíčová slova anglicky

ISCHEMIC-STROKE; CRYPTOGENIC STROKE; ORAL ANTICOAGULANTS; UNDETERMINED SOURCE; RISK; METAANALYSIS; RATIONALE; DESIGN; SCORE; SIZE

Štítky

14110127, rivok

Příznaky

Mezinárodní význam, Recenzováno

Změněno: 5. 5. 2020 09:23, Mgr. Tereza Miškechová

Anotace

V originále

IMPORTANCE The NAVIGATE ESUS randomized clinical trial found that 15 mg of rivaroxaban per day does not reduce stroke compared with aspirin in patients with embolic stroke of undetermined source (ESUS); however, it substantially reduces stroke risk in patients with atrial fibrillation (AF). OBJECTIVE To analyze whether rivaroxaban is associated with a reduction of recurrent stroke among patients with ESUS who have an increased risk of AF. DESIGN, SETTING, AND PARTICIPANTS Participants were stratified by predictors of AF, including left atrial diameter, frequency of premature atrial contractions, and HAVOC score, a validated scheme using clinical features. Treatment interactions with these predictors were assessed. Participants were enrolled between December 2014 and September 2017, and analysis began March 2018. INTERVENTION Rivaroxaban treatment vs aspirin. MAIN OUTCOMES AND MEASURES Risk of ischemic stroke. RESULTS Among 7112 patients with a mean (SD) age of 67 (9.8) years, the mean (SD) HAVOC score was 2.6(1.8), the mean (SD) left atrial diameter was 3.8(1.4) cm (n=4022), and the median (interquartile range) daily frequency of premature atrial contractions was 48 (13-222). Detection of AF during follow-up increased for each tertile of HAVOC score: 2.3% (score, 0-2), 3.0% (score, 3), and 5.8% (score, >3); however, neither tertiles of the HAVOC score nor premature atrial contractions frequency impacted the association of rivaroxaban with recurrent ischemic stroke (P for interaction=.67 and .96, respectively). Atrial fibrillation annual incidence increased for each tertile of left atrial diameter (2.0%, 3.6%, and 5.2%) and for each tertile of premature atrial contractions frequency (1.3%, 2.9%, and 7.0%). Among the predefined subgroup of patients with a left atrial diameter of more than 4.6 cm (9% of overall population), the risk of ischemic stroke was lower among the rivaroxaban group (1.7% per year) compared with the aspirin group (6.5% per year) (hazard ratio,0.26; 95% CI, 0.07-0.94; P for interaction=.02). CONCLUSIONS AND RELEVANCE The HAVOC score, left atrial diameter, and premature atrial contraction frequency predicted subsequent clinical AF. Rivaroxaban was associated with a reduced risk of recurrent stroke among patients with ESUS and moderate or severe left atrial enlargement; however, this needs to be independently confirmed before influencing clinical practice.

Citovat

HEALEY, J. S., D. J. GLADSTONE, B. SWAMINATHAN, J. ECKSTEIN, H. MUNDL, A. E. EPSTEIN, K. G. HAEUSLER, Robert MIKULÍK, S. E. KASNER, D. TONI, A. ARAUZ, G. NTAIOS, G. J. HANKEY, K. PERERA, J. PAGOLA, A. SHUAIB, H. LUTSEP, X. M. YANG, S. UCHIYAMA, M. ENDRES, S. B. COUTTS, M. KARLINSKI, A. CZLONKOWSKA, C. A. MOLINA, G. SANTO, S. D. BERKOWITZ, R. G. HART a S. J. CONNOLLY. Recurrent Stroke With Rivaroxaban Compared With Aspirin According to Predictors of Atrial Fibrillation Secondary Analysis of the NAVIGATE ESUS Randomized Clinical Trial. JAMA neurology. Chicago, IL: American Medical Association, 2019, roč. 76, č. 7, s. 764-773. ISSN 2168-6149. Dostupné z: https://dx.doi.org/10.1001/jamaneurol.2019.0617.

@article{1636376,
   author = {Healey, J. S. and Gladstone, D. J. and Swaminathan, B. and Eckstein, J. and Mundl, H. and Epstein, A. E. and Haeusler, K. G. and Mikulík, Robert and Kasner, S. E. and Toni, D. and Arauz, A. and Ntaios, G. and Hankey, G. J. and Perera, K. and Pagola, J. and Shuaib, A. and Lutsep, H. and Yang, X. M. and Uchiyama, S. and Endres, M. and Coutts, S. B. and Karlinski, M. and Czlonkowska, A. and Molina, C. A. and Santo, G. and Berkowitz, S. D. and Hart, R. G. and Connolly, S. J.},
   article_location = {Chicago, IL},
   article_number = {7},
   doi = {http://dx.doi.org/10.1001/jamaneurol.2019.0617},
   keywords = {ISCHEMIC-STROKE; CRYPTOGENIC STROKE; ORAL ANTICOAGULANTS; UNDETERMINED SOURCE; RISK; METAANALYSIS; RATIONALE; DESIGN; SCORE; SIZE},
   language = {eng},
   issn = {2168-6149},
   journal = {JAMA neurology},
   title = {Recurrent Stroke With Rivaroxaban Compared With Aspirin According to Predictors of Atrial Fibrillation Secondary Analysis of the NAVIGATE ESUS Randomized Clinical Trial},
   url = {http://dx.doi.org/10.1001/jamaneurol.2019.0617},
   volume = {76},
   year = {2019}
}

TY  - JOUR
ID  - 1636376
AU  - Healey, J. S. - Gladstone, D. J. - Swaminathan, B. - Eckstein, J. - Mundl, H. - Epstein, A. E. - Haeusler, K. G. - Mikulík, Robert - Kasner, S. E. - Toni, D. - Arauz, A. - Ntaios, G. - Hankey, G. J. - Perera, K. - Pagola, J. - Shuaib, A. - Lutsep, H. - Yang, X. M. - Uchiyama, S. - Endres, M. - Coutts, S. B. - Karlinski, M. - Czlonkowska, A. - Molina, C. A. - Santo, G. - Berkowitz, S. D. - Hart, R. G. - Connolly, S. J.
PY  - 2019
TI  - Recurrent Stroke With Rivaroxaban Compared With Aspirin According to Predictors of Atrial Fibrillation Secondary Analysis of the NAVIGATE ESUS Randomized Clinical Trial
JF  - JAMA neurology
VL  - 76
IS  - 7
SP  - 764-773
EP  - 764-773
PB  - American Medical Association
SN  - 21686149
KW  - ISCHEMIC-STROKE
KW  - CRYPTOGENIC STROKE
KW  - ORAL ANTICOAGULANTS
KW  - UNDETERMINED SOURCE
KW  - RISK
KW  - METAANALYSIS
KW  - RATIONALE
KW  - DESIGN
KW  - SCORE
KW  - SIZE
UR  - http://dx.doi.org/10.1001/jamaneurol.2019.0617
L2  - http://dx.doi.org/10.1001/jamaneurol.2019.0617
N2  - IMPORTANCE The NAVIGATE ESUS randomized clinical trial found that 15 mg of rivaroxaban per day does not reduce stroke compared with aspirin in patients with embolic stroke of undetermined source (ESUS); however, it substantially reduces stroke risk in patients with atrial fibrillation (AF). OBJECTIVE To analyze whether rivaroxaban is associated with a reduction of recurrent stroke among patients with ESUS who have an increased risk of AF. DESIGN, SETTING, AND PARTICIPANTS Participants were stratified by predictors of AF, including left atrial diameter, frequency of premature atrial contractions, and HAVOC score, a validated scheme using clinical features. Treatment interactions with these predictors were assessed. Participants were enrolled between December 2014 and September 2017, and analysis began March 2018. INTERVENTION Rivaroxaban treatment vs aspirin. MAIN OUTCOMES AND MEASURES Risk of ischemic stroke. RESULTS Among 7112 patients with a mean (SD) age of 67 (9.8) years, the mean (SD) HAVOC score was 2.6(1.8), the mean (SD) left atrial diameter was 3.8(1.4) cm (n=4022), and the median (interquartile range) daily frequency of premature atrial contractions was 48 (13-222). Detection of AF during follow-up increased for each tertile of HAVOC score: 2.3% (score, 0-2), 3.0% (score, 3), and 5.8% (score, >3); however, neither tertiles of the HAVOC score nor premature atrial contractions frequency impacted the association of rivaroxaban with recurrent ischemic stroke (P for interaction=.67 and .96, respectively). Atrial fibrillation annual incidence increased for each tertile of left atrial diameter (2.0%, 3.6%, and 5.2%) and for each tertile of premature atrial contractions frequency (1.3%, 2.9%, and 7.0%). Among the predefined subgroup of patients with a left atrial diameter of more than 4.6 cm (9% of overall population), the risk of ischemic stroke was lower among the rivaroxaban group (1.7% per year) compared with the aspirin group (6.5% per year) (hazard ratio,0.26; 95% CI, 0.07-0.94; P for interaction=.02). CONCLUSIONS AND RELEVANCE The HAVOC score, left atrial diameter, and premature atrial contraction frequency predicted subsequent clinical AF. Rivaroxaban was associated with a reduced risk of recurrent stroke among patients with ESUS and moderate or severe left atrial enlargement; however, this needs to be independently confirmed before influencing clinical practice.
ER  -

HEALEY, J. S., D. J. GLADSTONE, B. SWAMINATHAN, J. ECKSTEIN, H. MUNDL, A. E. EPSTEIN, K. G. HAEUSLER, Robert MIKULÍK, S. E. KASNER, D. TONI, A. ARAUZ, G. NTAIOS, G. J. HANKEY, K. PERERA, J. PAGOLA, A. SHUAIB, H. LUTSEP, X. M. YANG, S. UCHIYAMA, M. ENDRES, S. B. COUTTS, M. KARLINSKI, A. CZLONKOWSKA, C. A. MOLINA, G. SANTO, S. D. BERKOWITZ, R. G. HART a S. J. CONNOLLY. Recurrent Stroke With Rivaroxaban Compared With Aspirin According to Predictors of Atrial Fibrillation Secondary Analysis of the NAVIGATE ESUS Randomized Clinical Trial. \textit{JAMA neurology}. Chicago, IL: American Medical Association, 2019, roč.~76, č.~7, s.~764-773. ISSN~2168-6149. Dostupné z: https://dx.doi.org/10.1001/jamaneurol.2019.0617.

Podrobný výpis o publikaci