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 and 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, vol. 76, No 7, p. 764-773. ISSN 2168-6149. Available from: https://dx.doi.org/10.1001/jamaneurol.2019.0617.
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Basic information
Original name Recurrent Stroke With Rivaroxaban Compared With Aspirin According to Predictors of Atrial Fibrillation Secondary Analysis of the NAVIGATE ESUS Randomized Clinical Trial
Authors HEALEY, J. S. (124 Canada, guarantor), D. J. GLADSTONE (124 Canada), B. SWAMINATHAN (124 Canada), J. ECKSTEIN (756 Switzerland), H. MUNDL (276 Germany), A. E. EPSTEIN (840 United States of America), K. G. HAEUSLER (276 Germany), Robert MIKULÍK (203 Czech Republic, belonging to the institution), S. E. KASNER (840 United States of America), D. TONI (380 Italy), A. ARAUZ (484 Mexico), G. NTAIOS (300 Greece), G. J. HANKEY (36 Australia), K. PERERA (124 Canada), J. PAGOLA (124 Canada), A. SHUAIB (124 Canada), H. LUTSEP (840 United States of America), X. M. YANG (156 China), S. UCHIYAMA (392 Japan), M. ENDRES (276 Germany), S. B. COUTTS (124 Canada), M. KARLINSKI (616 Poland), A. CZLONKOWSKA (616 Poland), C. A. MOLINA (724 Spain), G. SANTO (620 Portugal), S. D. BERKOWITZ (840 United States of America), R. G. HART (124 Canada) and S. J. CONNOLLY (124 Canada).
Edition JAMA neurology, Chicago, IL, American Medical Association, 2019, 2168-6149.
Other information
Original language English
Type of outcome Article in a journal
Field of Study 30210 Clinical neurology
Country of publisher United States of America
Confidentiality degree is not subject to a state or trade secret
WWW URL
Impact factor Impact factor: 13.608
RIV identification code RIV/00216224:14110/19:00113269
Organization unit Faculty of Medicine
Doi http://dx.doi.org/10.1001/jamaneurol.2019.0617
UT WoS 000483154300006
Keywords in English ISCHEMIC-STROKE; CRYPTOGENIC STROKE; ORAL ANTICOAGULANTS; UNDETERMINED SOURCE; RISK; METAANALYSIS; RATIONALE; DESIGN; SCORE; SIZE
Tags 14110127, rivok
Tags International impact, Reviewed
Changed by Changed by: Mgr. Tereza Miškechová, učo 341652. Changed: 5/5/2020 09:23.
Abstract
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.
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