-
Je něco špatně v tomto záznamu ?
Rivaroxaban versus aspirin for prevention of covert brain infarcts in patients with embolic stroke of undetermined source: NAVIGATE ESUS MRI substudy
M. Sharma, EE. Smith, LA. Pearce, KS. Perera, SE. Kasner, BW. Yoon, SF. Ameriso, J. Puig, D. Damgaard, JB. Fiebach, KW. Muir, RC. Veltkamp, DS. Toni, N. Shamalov, RJ. Gagliardi, R. Mikulik, ST. Engelter, D. Bereczki, MJ. O'Donnell, F. Saad, A....
Jazyk angličtina Země Spojené státy americké
Typ dokumentu časopisecké články, randomizované kontrolované studie
Grantová podpora
MR/N003403/1
Medical Research Council - United Kingdom
- MeSH
- Aspirin terapeutické užití MeSH
- cerebrální krvácení farmakoterapie MeSH
- cévní mozková příhoda * diagnostické zobrazování farmakoterapie prevence a kontrola MeSH
- dvojitá slepá metoda MeSH
- embolická cévní mozková příhoda * MeSH
- inhibitory faktoru Xa terapeutické užití MeSH
- intrakraniální embolie * diagnostické zobrazování farmakoterapie epidemiologie MeSH
- lidé MeSH
- magnetická rezonanční tomografie MeSH
- mozkový infarkt diagnostické zobrazování farmakoterapie etiologie MeSH
- prospektivní studie MeSH
- rivaroxaban terapeutické užití MeSH
- senioři MeSH
- Check Tag
- lidé MeSH
- mužské pohlaví MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- randomizované kontrolované studie MeSH
BACKGROUND: Covert brain infarcts are associated with important neurological morbidity. Their incidence in patients with embolic stroke of undetermined source (ESUS) is unknown. AIMS: To assess the incidence of covert brain infarcts and cerebral microbleeds using MRI in a prospective substudy of the NAVIGATE ESUS randomized trial and to evaluate the effects of antithrombotic therapies. METHODS: At 87 sites in 15 countries, substudy participants were randomly assigned to receive rivaroxaban 15 mg daily or aspirin 100 mg daily and underwent brain MRI near randomization and after study termination. The primary outcome was incident brain infarct (clinical ischemic stroke or covert brain infarct). Brain infarcts and microbleeds were ascertained centrally by readers unaware of treatment. Treatment effects were estimated using logistic regression. RESULTS: Among the 718 substudy participants with interpretable, paired MRIs, the mean age was 67 years and 61% were men with a median of 52 days between the qualifying ischemic stroke and randomization and a median of seven days between randomization and baseline MRI. During the median (IQR) 11 (12) month interval between scans, clinical ischemic strokes occurred in 27 (4%) participants, while 60 (9%) of the remaining participants had an incident covert brain infarct detected by MRI. Assignment to rivaroxaban was not associated with reduction in the incidence of brain infarct (OR 0.77, 95% CI 0.49, 1.2) or of covert brain infarct among those without clinical stroke (OR 0.85, 95% CI 0.50, 1.4). New microbleeds were observed in 7% and did not differ among those assigned rivaroxaban vs. aspirin (HR 0.95, 95% CI 0.52-1.7). CONCLUSIONS: Incident covert brain infarcts occurred in twice as many ESUS patients as a clinical ischemic stroke. Treatment with rivaroxaban compared with aspirin did not significantly reduce the incidence of covert brain infarcts or increase the incidence of microbleeds, but the confidence intervals for treatment effects were wide.Registration: https://www.clinicaltrials.gov. Unique identifier: NCT02313909.
Center for Stroke Research Charite Universitatsmedizin Berlin Berlin Germany
Department of Brain Sciences 4615Imperial College London London UK
Department of Clinical Neurosciences 2129University of Calgary Calgary AB Canada
Department of Human Neurosciences Sapienza University of Rome Rome Italy
Department of Neurology Aarhus University Hospital Aarhus Denmark
Department of Neurology Semmelweis University Budapest Hungary
Department of Neurology Seoul National University Hospital Seoul Korea
Department of Neurology University of Pennsylvania Philadelphia PA USA
Department of Radiology Girona Biomedical Research Institute Hospital Dr Josep Trueta Girona Spain
Federal Center of Brain Research and Neurotechnology Federal Medical Biological Agency Moscow Russia
HRB Clinical Research Facility National University Ireland Galway Ireland
Irmandade da Santa Casa de Misericórdia de São Paulo Sao Paulo Brazil
Pharmaceuticals Clinical Development Thrombosis Bayer U S LLC Whippany NJ USA
Population Health Research Institute Hamilton Health Sciences Hamilton ON Canada
Citace poskytuje Crossref.org
- 000
- 00000naa a2200000 a 4500
- 001
- bmc22025043
- 003
- CZ-PrNML
- 005
- 20221031100813.0
- 007
- ta
- 008
- 221017s2022 xxu f 000 0|eng||
- 009
- AR
- 024 7_
- $a 10.1177/17474930211058012 $2 doi
- 035 __
- $a (PubMed)34791941
- 040 __
- $a ABA008 $b cze $d ABA008 $e AACR2
- 041 0_
- $a eng
- 044 __
- $a xxu
- 100 1_
- $a Sharma, Mukul $u Department of Medicine (Neurology), McMaster University, Population Health Research Institute, Hamilton Health Sciences, Hamilton, ON, Canada $1 https://orcid.org/https://orcid.org/000000026119342X
- 245 10
- $a Rivaroxaban versus aspirin for prevention of covert brain infarcts in patients with embolic stroke of undetermined source: NAVIGATE ESUS MRI substudy / $c M. Sharma, EE. Smith, LA. Pearce, KS. Perera, SE. Kasner, BW. Yoon, SF. Ameriso, J. Puig, D. Damgaard, JB. Fiebach, KW. Muir, RC. Veltkamp, DS. Toni, N. Shamalov, RJ. Gagliardi, R. Mikulik, ST. Engelter, D. Bereczki, MJ. O'Donnell, F. Saad, A. Shoamanesh, SD. Berkowitz, H. Mundl, RG. Hart, NAVIGATE ESUS MRI Substudy Investigators
- 520 9_
- $a BACKGROUND: Covert brain infarcts are associated with important neurological morbidity. Their incidence in patients with embolic stroke of undetermined source (ESUS) is unknown. AIMS: To assess the incidence of covert brain infarcts and cerebral microbleeds using MRI in a prospective substudy of the NAVIGATE ESUS randomized trial and to evaluate the effects of antithrombotic therapies. METHODS: At 87 sites in 15 countries, substudy participants were randomly assigned to receive rivaroxaban 15 mg daily or aspirin 100 mg daily and underwent brain MRI near randomization and after study termination. The primary outcome was incident brain infarct (clinical ischemic stroke or covert brain infarct). Brain infarcts and microbleeds were ascertained centrally by readers unaware of treatment. Treatment effects were estimated using logistic regression. RESULTS: Among the 718 substudy participants with interpretable, paired MRIs, the mean age was 67 years and 61% were men with a median of 52 days between the qualifying ischemic stroke and randomization and a median of seven days between randomization and baseline MRI. During the median (IQR) 11 (12) month interval between scans, clinical ischemic strokes occurred in 27 (4%) participants, while 60 (9%) of the remaining participants had an incident covert brain infarct detected by MRI. Assignment to rivaroxaban was not associated with reduction in the incidence of brain infarct (OR 0.77, 95% CI 0.49, 1.2) or of covert brain infarct among those without clinical stroke (OR 0.85, 95% CI 0.50, 1.4). New microbleeds were observed in 7% and did not differ among those assigned rivaroxaban vs. aspirin (HR 0.95, 95% CI 0.52-1.7). CONCLUSIONS: Incident covert brain infarcts occurred in twice as many ESUS patients as a clinical ischemic stroke. Treatment with rivaroxaban compared with aspirin did not significantly reduce the incidence of covert brain infarcts or increase the incidence of microbleeds, but the confidence intervals for treatment effects were wide.Registration: https://www.clinicaltrials.gov. Unique identifier: NCT02313909.
- 650 _2
- $a senioři $7 D000368
- 650 _2
- $a Aspirin $x terapeutické užití $7 D001241
- 650 _2
- $a mozkový infarkt $x diagnostické zobrazování $x farmakoterapie $x etiologie $7 D020520
- 650 _2
- $a cerebrální krvácení $x farmakoterapie $7 D002543
- 650 _2
- $a dvojitá slepá metoda $7 D004311
- 650 12
- $a embolická cévní mozková příhoda $7 D000083262
- 650 _2
- $a inhibitory faktoru Xa $x terapeutické užití $7 D065427
- 650 _2
- $a ženské pohlaví $7 D005260
- 650 _2
- $a lidé $7 D006801
- 650 12
- $a intrakraniální embolie $x diagnostické zobrazování $x farmakoterapie $x epidemiologie $7 D020766
- 650 _2
- $a magnetická rezonanční tomografie $7 D008279
- 650 _2
- $a mužské pohlaví $7 D008297
- 650 _2
- $a prospektivní studie $7 D011446
- 650 _2
- $a rivaroxaban $x terapeutické užití $7 D000069552
- 650 12
- $a cévní mozková příhoda $x diagnostické zobrazování $x farmakoterapie $x prevence a kontrola $7 D020521
- 655 _2
- $a časopisecké články $7 D016428
- 655 _2
- $a randomizované kontrolované studie $7 D016449
- 700 1_
- $a Smith, Eric E $u Department of Clinical Neurosciences, 2129University of Calgary, Calgary, AB, Canada
- 700 1_
- $a Pearce, Lesly A $u St. Catharines, Ontario, Canada
- 700 1_
- $a Perera, Kanjana S $u Department of Medicine (Neurology), McMaster University, Population Health Research Institute, Hamilton Health Sciences, Hamilton, ON, Canada
- 700 1_
- $a Kasner, Scott E $u Department of Neurology, University of Pennsylvania, Philadelphia, PA, USA
- 700 1_
- $a Yoon, Byung-Woo $u Department of Neurology, Seoul National University Hospital, Seoul, Korea
- 700 1_
- $a Ameriso, Sebastian F $u Division de Neurologia Vascular, Departmento de Neurologia, Institute for Neurological Research-FLENI, Cuidad Autonoma, Buenos Aires, Argentina $1 https://orcid.org/https://orcid.org/0000000189330847
- 700 1_
- $a Puig, Josep $u Department of Radiology, Girona Biomedical Research Institute, Hospital Dr. Josep Trueta, Girona, Spain
- 700 1_
- $a Damgaard, Dorte $u Department of Neurology, Aarhus University Hospital, Aarhus, Denmark
- 700 1_
- $a Fiebach, Jochen B $u Center for Stroke Research, Charite - Universitatsmedizin Berlin, Berlin, Germany
- 700 1_
- $a Muir, Keith W $u Institute of Neuroscience & Psychology, University of Glasgow, Queen Elizabeth University Hospital, Glasgow, UK $1 https://orcid.org/https://orcid.org/000000019535022X
- 700 1_
- $a Veltkamp, Roland C $u Department of Brain Sciences, 4615Imperial College London, London, UK
- 700 1_
- $a Toni, Danilo S $u Department of Human Neurosciences, "Sapienza" University of Rome, Rome, Italy
- 700 1_
- $a Shamalov, Nikolay $u Federal Center of Brain Research and Neurotechnology, Federal Medical Biological Agency, Moscow, Russia
- 700 1_
- $a Gagliardi, Rubens J $u Irmandade da Santa Casa de Misericórdia de São Paulo, Sao Paulo, Brazil
- 700 1_
- $a Mikulik, Robert $u International Clinical Research Center and Neurology Department, St. Anne's University Hospital and Masaryk University, Brno, Czech Republic
- 700 1_
- $a Engelter, Stefan T $u University Department of Geriatic Medicine Felix Platter, Department of Neurology, University of Basel, University Hospital Basel, Basel, Switzerland
- 700 1_
- $a Bereczki, Daniel $u Department of Neurology, Semmelweis University, Budapest, Hungary $1 https://orcid.org/https://orcid.org/0000000283740500
- 700 1_
- $a O'Donnell, Martin J $u HRB-Clinical Research Facility, National University Ireland, Galway, Ireland
- 700 1_
- $a Saad, Feryal $u Department of Clinical Neurosciences, 2129University of Calgary, Calgary, AB, Canada
- 700 1_
- $a Shoamanesh, Ashkan $u Department of Medicine (Neurology), McMaster University, Population Health Research Institute, Hamilton Health Sciences, Hamilton, ON, Canada $1 https://orcid.org/https://orcid.org/0000000228021626
- 700 1_
- $a Berkowitz, Scott D $u Pharmaceuticals Clinical Development Thrombosis, Bayer U.S. LLC, Whippany, NJ, USA
- 700 1_
- $a Mundl, Hardi $u Bayer AG, Wuppertal, Germany $1 https://orcid.org/https://orcid.org/0000000162183058
- 700 1_
- $a Hart, Robert G $u Population Health Research Institute, Hamilton Health Sciences, Hamilton, ON, Canada
- 710 2_
- $a NAVIGATE ESUS MRI Substudy Investigators
- 773 0_
- $w MED00176295 $t International journal of stroke $x 1747-4949 $g Roč. 17, č. 7 (2022), s. 799-805
- 856 41
- $u https://pubmed.ncbi.nlm.nih.gov/34791941 $y Pubmed
- 910 __
- $a ABA008 $b sig $c sign $y p $z 0
- 990 __
- $a 20221017 $b ABA008
- 991 __
- $a 20221031100810 $b ABA008
- 999 __
- $a ok $b bmc $g 1854644 $s 1176333
- BAS __
- $a 3
- BAS __
- $a PreBMC
- BMC __
- $a 2022 $b 17 $c 7 $d 799-805 $e 20211118 $i 1747-4949 $m International journal of stroke $n Int J Stroke $x MED00176295
- GRA __
- $a MR/N003403/1 $p Medical Research Council $2 United Kingdom
- LZP __
- $a Pubmed-20221017
