-
Je něco špatně v tomto záznamu ?
Antithrombotic Treatment of Embolic Stroke of Undetermined Source: RE-SPECT ESUS Elderly and Renally Impaired Subgroups
HC. Diener, RL. Sacco, JD. Easton, CB. Granger, M. Bar, RA. Bernstein, M. Brainin, M. Brueckmann, L. Cronin, G. Donnan, Z. Gdovinová, C. Grauer, E. Kleine, TJ. Kleinig, P. Lyrer, S. Martins, J. Meyerhoff, T. Milling, W. Pfeilschifter, S. Poli, M....
Jazyk angličtina Země Spojené státy americké
Typ dokumentu srovnávací studie, časopisecké články, multicentrická studie, randomizované kontrolované studie, práce podpořená grantem
Grantová podpora
K23 HL127227
NHLBI NIH HHS - United States
NLK
Free Medical Journals
od 1970 do Před 1 rokem
Open Access Digital Library
od 1970-01-01
Open Access Digital Library
od 1970-01-01
- MeSH
- Aspirin * aplikace a dávkování farmakokinetika MeSH
- cévní mozková příhoda * krev farmakoterapie MeSH
- dabigatran * aplikace a dávkování farmakokinetika MeSH
- dvojitá slepá metoda MeSH
- fibrinolytika * aplikace a dávkování farmakokinetika MeSH
- intrakraniální embolie * krev farmakoterapie MeSH
- lidé středního věku MeSH
- lidé MeSH
- nemoci ledvin * krev farmakoterapie MeSH
- recidiva MeSH
- senioři nad 80 let MeSH
- senioři MeSH
- Check Tag
- lidé středního věku MeSH
- lidé MeSH
- mužské pohlaví MeSH
- senioři nad 80 let MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- multicentrická studie MeSH
- práce podpořená grantem MeSH
- randomizované kontrolované studie MeSH
- srovnávací studie MeSH
Background and Purpose- The RE-SPECT ESUS trial (Randomized, Double-Blind, Evaluation in Secondary Stroke Prevention Comparing the Efficacy and Safety of the Oral Thrombin Inhibitor Dabigatran Etexilate Versus Acetylsalicylic Acid in Patients With Embolic Stroke of Undetermined Source) tested the hypothesis that dabigatran would be superior to aspirin for the prevention of recurrent stroke in patients with embolic stroke of undetermined source. This exploratory subgroup analysis investigates the impact of age, renal function (both predefined), and dabigatran dose (post hoc) on the rates of recurrent stroke and major bleeding. Methods- RE-SPECT ESUS was a multicenter, randomized, double-blind trial of dabigatran 150 or 110 mg (for patients aged ≥75 years and/or with creatinine clearance 30 to <50 mL/minute) twice daily compared with aspirin 100 mg once daily. The primary outcome was recurrent stroke. Results- The trial, which enrolled 5390 patients from December 2014 to January 2018, did not demonstrate superiority of dabigatran versus aspirin for prevention of recurrent stroke in patients with embolic stroke of undetermined source. However, among the population qualifying for the lower dabigatran dose, the rate of recurrent stroke was reduced with dabigatran versus aspirin (7.4% versus 13.0%; hazard ratio, 0.57 [95% CI, 0.39-0.82]; interaction P=0.01). This was driven mainly by the subgroup aged ≥75 years (7.8% versus 12.4%; hazard ratio, 0.63 [95% CI, 0.43-0.94]; interaction P=0.10). Stroke rates tended to be lower with dabigatran versus aspirin with declining renal function. Risks for major bleeding were similar between treatments, irrespective of renal function, but with a trend for lower bleeding rates with dabigatran versus aspirin in older patients. Conclusions- In subgroup analyses of RE-SPECT ESUS, dabigatran reduced the rate of recurrent stroke compared with aspirin in patients qualifying for the lower dose of dabigatran. These results are hypothesis-generating. Aspirin remains the standard antithrombotic treatment for patients with embolic stroke of undetermined source. Registration- URL: https://www.clinicaltrials.gov; Unique identifier: NCT02239120.
Biostatistics and Data Sciences Boehringer Ingelheim Pharma GmbH and Co K G Ingelheim Germany
Cardiology Medicine Boehringer Ingelheim International GmbH Germany
Cardiometabolic Medicine Boehringer Ingelheim Ltd Burlington ON Canada
Center of Neurology and Neurosurgery Goethe University Frankfurt Frankfurt am Main Germany
Clinical and Translational Science Miller School of Medicine University of Miami FL
Clinical Operations Global Boehringer Ingelheim Pharma GmbH and Co K G Biberach Germany
Comprehensive Stroke Center Department of Neurology Palacky University Olomouc Czech Republic
Department of Neurology Cerebrovaskulární ambulance s r o Brno Czech Republic
Department of Neurology Evangelisches Klinikum Bethel Bielefeld Germany
Department of Neurology Melbourne Brain Centre University of Melbourne Parkville VIC Australia
Department of Neurology Morsani College of Medicine University of South Florida Tampa
Department of Neurology Northwestern University Chicago IL
Department of Neurology Royal Adelaide Hospital Adelaide South Australia Australia
Department of Neurology University Hospital Ostrava Ostrava Poruba Poruba Czech Republic
Department of Neurology University of California San Francisco
Division of Neurology Stroke Center University Hospital Basel Switzerland
Duke Clinical Research Institute Duke University Medical Center Durham NC
Metabolism Medicine Boehringer Ingelheim International GmbH Germany
Neurology Service Hospital de Clínicas de Porto Alegre Brazil
Citace poskytuje Crossref.org
- 000
- 00000naa a2200000 a 4500
- 001
- bmc20024996
- 003
- CZ-PrNML
- 005
- 20201222155002.0
- 007
- ta
- 008
- 201125s2020 xxu f 000 0|eng||
- 009
- AR
- 024 7_
- $a 10.1161/STROKEAHA.119.028643 $2 doi
- 035 __
- $a (PubMed)32404035
- 040 __
- $a ABA008 $b cze $d ABA008 $e AACR2
- 041 0_
- $a eng
- 044 __
- $a xxu
- 100 1_
- $a Diener, Hans-Christoph $u From the Faculty of Medicine, Institute for Medical Informatics, Biometry and Epidemiology, University Duisburg-Essen, Germany (H.-C.D.).
- 245 10
- $a Antithrombotic Treatment of Embolic Stroke of Undetermined Source: RE-SPECT ESUS Elderly and Renally Impaired Subgroups / $c HC. Diener, RL. Sacco, JD. Easton, CB. Granger, M. Bar, RA. Bernstein, M. Brainin, M. Brueckmann, L. Cronin, G. Donnan, Z. Gdovinová, C. Grauer, E. Kleine, TJ. Kleinig, P. Lyrer, S. Martins, J. Meyerhoff, T. Milling, W. Pfeilschifter, S. Poli, M. Reif, DZ. Rose, D. Šaňák, WR. Schäbitz,
- 520 9_
- $a Background and Purpose- The RE-SPECT ESUS trial (Randomized, Double-Blind, Evaluation in Secondary Stroke Prevention Comparing the Efficacy and Safety of the Oral Thrombin Inhibitor Dabigatran Etexilate Versus Acetylsalicylic Acid in Patients With Embolic Stroke of Undetermined Source) tested the hypothesis that dabigatran would be superior to aspirin for the prevention of recurrent stroke in patients with embolic stroke of undetermined source. This exploratory subgroup analysis investigates the impact of age, renal function (both predefined), and dabigatran dose (post hoc) on the rates of recurrent stroke and major bleeding. Methods- RE-SPECT ESUS was a multicenter, randomized, double-blind trial of dabigatran 150 or 110 mg (for patients aged ≥75 years and/or with creatinine clearance 30 to <50 mL/minute) twice daily compared with aspirin 100 mg once daily. The primary outcome was recurrent stroke. Results- The trial, which enrolled 5390 patients from December 2014 to January 2018, did not demonstrate superiority of dabigatran versus aspirin for prevention of recurrent stroke in patients with embolic stroke of undetermined source. However, among the population qualifying for the lower dabigatran dose, the rate of recurrent stroke was reduced with dabigatran versus aspirin (7.4% versus 13.0%; hazard ratio, 0.57 [95% CI, 0.39-0.82]; interaction P=0.01). This was driven mainly by the subgroup aged ≥75 years (7.8% versus 12.4%; hazard ratio, 0.63 [95% CI, 0.43-0.94]; interaction P=0.10). Stroke rates tended to be lower with dabigatran versus aspirin with declining renal function. Risks for major bleeding were similar between treatments, irrespective of renal function, but with a trend for lower bleeding rates with dabigatran versus aspirin in older patients. Conclusions- In subgroup analyses of RE-SPECT ESUS, dabigatran reduced the rate of recurrent stroke compared with aspirin in patients qualifying for the lower dose of dabigatran. These results are hypothesis-generating. Aspirin remains the standard antithrombotic treatment for patients with embolic stroke of undetermined source. Registration- URL: https://www.clinicaltrials.gov; Unique identifier: NCT02239120.
- 650 _2
- $a senioři $7 D000368
- 650 _2
- $a senioři nad 80 let $7 D000369
- 650 12
- $a Aspirin $x aplikace a dávkování $x farmakokinetika $7 D001241
- 650 12
- $a dabigatran $x aplikace a dávkování $x farmakokinetika $7 D000069604
- 650 _2
- $a dvojitá slepá metoda $7 D004311
- 650 _2
- $a ženské pohlaví $7 D005260
- 650 12
- $a fibrinolytika $x aplikace a dávkování $x farmakokinetika $7 D005343
- 650 _2
- $a lidé $7 D006801
- 650 12
- $a intrakraniální embolie $x krev $x farmakoterapie $7 D020766
- 650 12
- $a nemoci ledvin $x krev $x farmakoterapie $7 D007674
- 650 _2
- $a mužské pohlaví $7 D008297
- 650 _2
- $a lidé středního věku $7 D008875
- 650 _2
- $a recidiva $7 D012008
- 650 12
- $a cévní mozková příhoda $x krev $x farmakoterapie $7 D020521
- 655 _2
- $a srovnávací studie $7 D003160
- 655 _2
- $a časopisecké články $7 D016428
- 655 _2
- $a multicentrická studie $7 D016448
- 655 _2
- $a randomizované kontrolované studie $7 D016449
- 655 _2
- $a práce podpořená grantem $7 D013485
- 700 1_
- $a Sacco, Ralph L $u Clinical and Translational Science, Miller School of Medicine, University of Miami, FL (R.L.S.).
- 700 1_
- $a Easton, J Donald $u Department of Neurology, University of California, San Francisco (J.D.E.).
- 700 1_
- $a Granger, Christopher B $u Duke Clinical Research Institute, Duke University Medical Center, Durham, NC (C.B.G.).
- 700 1_
- $a Bar, Michal $u Department of Neurology, University Hospital Ostrava, Ostrava-Poruba-Poruba, Czech Republic (M. Bar).
- 700 1_
- $a Bernstein, Richard A $u Department of Neurology, Northwestern University, Chicago, IL (R.A.B.).
- 700 1_
- $a Brainin, Michael $u Department of Neurosciences and Preventive Medicine, Danube University Krems, Krems an der Donau, Austria (M. Brainin).
- 700 1_
- $a Brueckmann, Martina $u Metabolism Medicine, Boehringer Ingelheim International GmbH, Germany (M. Brueckmann). Faculty of Medicine Mannheim of the University of Heidelberg, Germany (M. Brueckmann).
- 700 1_
- $a Cronin, Lisa $u Cardiometabolic Medicine, Boehringer Ingelheim Ltd, Burlington, ON, Canada (L.C.).
- 700 1_
- $a Donnan, Geoffrey $u Department of Neurology, Melbourne Brain Centre, University of Melbourne, Parkville, VIC, Australia (G.D.).
- 700 1_
- $a Gdovinová, Zuzana $u Department of Neurology, Pavol Jozef Šafárik University in Košice, University Hospital L. Pasteur, Košice, Slovak Republic (Z.G.).
- 700 1_
- $a Grauer, Claudia $u Clinical Operations Global, Boehringer Ingelheim Pharma GmbH & Co. K.G., Biberach, Germany (C.G.).
- 700 1_
- $a Kleine, Eva $u Biostatistics and Data Sciences, Boehringer Ingelheim Pharma GmbH & Co. K.G., Ingelheim, Germany (E.K.).
- 700 1_
- $a Kleinig, Timothy J $u Department of Neurology, Royal Adelaide Hospital, Adelaide, South Australia, Australia (T.J.K.).
- 700 1_
- $a Lyrer, Philippe $u Division of Neurology, Stroke Center, University Hospital Basel, Switzerland (P.L.).
- 700 1_
- $a Martins, Sheila $u Neurology Service, Hospital de Clínicas de Porto Alegre, Brazil (S.M.).
- 700 1_
- $a Meyerhoff, Juliane $u Cardiology Medicine, Boehringer Ingelheim International GmbH, Germany (J.M.).
- 700 1_
- $a Milling, Truman $u Department of Neurology, Department of Surgery and Perioperative Care, Seton Dell Medical School Stroke Institute, Austin, TX (T.M.).
- 700 1_
- $a Pfeilschifter, Waltraud $u Center of Neurology and Neurosurgery, Goethe University Frankfurt, Frankfurt am Main, Germany (W.P.).
- 700 1_
- $a Poli, Sven $u Department of Neurology with Focus on Neurovascular Diseases and Neurooncology, University of Tübingen, and Hertie Institute for Clinical Brain Research, Germany (S.P.).
- 700 1_
- $a Reif, Michal $u Department of Neurology, Cerebrovaskulární ambulance s.r.o., Brno, Czech Republic (M.R.).
- 700 1_
- $a Rose, David Z $u Department of Neurology, Morsani College of Medicine, University of South Florida, Tampa (D.Z.R.).
- 700 1_
- $a Šaňák, Daniel $u Comprehensive Stroke Center, Department of Neurology, Palacky University, Olomouc, Czech Republic (D.S.).
- 700 1_
- $a Schäbitz, Wolf-Rüdiger $u Department of Neurology, Evangelisches Klinikum Bethel, Bielefeld, Germany (W.-R.S.).
- 773 0_
- $w MED00010659 $t Stroke $x 1524-4628 $g Roč. 51, č. 6 (2020), s. 1758-1765
- 856 41
- $u https://pubmed.ncbi.nlm.nih.gov/32404035 $y Pubmed
- 910 __
- $a ABA008 $b sig $c sign $y a $z 0
- 990 __
- $a 20201125 $b ABA008
- 991 __
- $a 20201222154959 $b ABA008
- 999 __
- $a ok $b bmc $g 1599141 $s 1115682
- BAS __
- $a 3
- BAS __
- $a PreBMC
- BMC __
- $a 2020 $b 51 $c 6 $d 1758-1765 $e 20200514 $i 1524-4628 $m Stroke $n Stroke $x MED00010659
- GRA __
- $a K23 HL127227 $p NHLBI NIH HHS $2 United States
- LZP __
- $a Pubmed-20201125
