Your browser doesn't support javascript.
loading
Apixaban to Prevent Recurrence After Cryptogenic Stroke in Patients With Atrial Cardiopathy: The ARCADIA Randomized Clinical Trial.
Kamel, Hooman; Longstreth, W T; Tirschwell, David L; Kronmal, Richard A; Marshall, Randolph S; Broderick, Joseph P; Aragón García, Rebeca; Plummer, Pamela; Sabagha, Noor; Pauls, Qi; Cassarly, Christy; Dillon, Catherine R; Di Tullio, Marco R; Hod, Eldad A; Soliman, Elsayed Z; Gladstone, David J; Healey, Jeff S; Sharma, Mukul; Chaturvedi, Seemant; Janis, L Scott; Krishnaiah, Balaji; Nahab, Fadi; Kasner, Scott E; Stanton, Robert J; Kleindorfer, Dawn O; Starr, Matthew; Winder, Toni R; Clark, Wayne M; Miller, Benjamin R; Elkind, Mitchell S V.
Afiliación
  • Kamel H; Clinical and Translational Neuroscience Unit, Department of Neurology and Feil Family Brain and Mind Research Institute, Weill Cornell Medicine, New York, New York.
  • Longstreth WT; Department of Neurology, University of Washington, Seattle.
  • Tirschwell DL; Department of Medicine, University of Washington, Seattle.
  • Kronmal RA; Department of Epidemiology, University of Washington, Seattle.
  • Marshall RS; Department of Neurology, University of Washington, Seattle.
  • Broderick JP; Department of Biostatistics, University of Washington, Seattle.
  • Aragón García R; Department of Neurology, Vagelos College of Physicians and Surgeons, Columbia University, New York, New York.
  • Plummer P; Department of Neurology and Rehabilitation Medicine, University of Cincinnati College of Medicine, Cincinnati, Ohio.
  • Sabagha N; Department of Neurology, Vagelos College of Physicians and Surgeons, Columbia University, New York, New York.
  • Pauls Q; Department of Neurology and Rehabilitation Medicine, University of Cincinnati College of Medicine, Cincinnati, Ohio.
  • Cassarly C; Department of Neurology and Rehabilitation Medicine, University of Cincinnati College of Medicine, Cincinnati, Ohio.
  • Dillon CR; Department of Public Health Sciences, Medical University of South Carolina, Charleston.
  • Di Tullio MR; Department of Public Health Sciences, Medical University of South Carolina, Charleston.
  • Hod EA; Department of Public Health Sciences, Medical University of South Carolina, Charleston.
  • Soliman EZ; Division of Cardiology, Vagelos College of Physicians and Surgeons, Columbia University, New York, New York.
  • Gladstone DJ; Department of Pathology, Vagelos College of Physicians and Surgeons, Columbia University, New York, New York.
  • Healey JS; Epidemiological Cardiology Research Center, Department of Internal Medicine, Wake Forest School of Medicine, Winston-Salem, North Carolina.
  • Sharma M; Sunnybrook Research Institute, Hurvitz Brain Sciences Program, Sunnybrook Health Sciences Centre, and Division of Neurology, Department of Medicine, University of Toronto, Toronto, Ontario, Canada.
  • Chaturvedi S; Population Health Research Institute, McMaster University, Hamilton, Ontario, Canada.
  • Janis LS; Population Health Research Institute, McMaster University, Hamilton, Ontario, Canada.
  • Krishnaiah B; Department of Neurology, University of Maryland, and Baltimore VA Hospital, Baltimore.
  • Nahab F; National Institute of Neurological Disorders and Stroke, National Institutes of Health, Bethesda, Maryland.
  • Kasner SE; Department of Neurology, University of Tennessee Health Sciences Center, Memphis.
  • Stanton RJ; Departments of Neurology and Pediatrics, Emory University, Atlanta, Georgia.
  • Kleindorfer DO; Department of Neurology, Perelman School of Medicine, University of Pennsylvania, Philadelphia.
  • Starr M; Department of Neurology and Rehabilitation Medicine, University of Cincinnati College of Medicine, Cincinnati, Ohio.
  • Winder TR; Department of Neurology, University of Michigan, Ann Arbor.
  • Clark WM; Department of Neurology, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania.
  • Miller BR; Neurologic Research Center, Lethbridge, Alberta, Canada.
  • Elkind MSV; Department of Neurology, Oregon Health & Science University, Portland.
JAMA ; 331(7): 573-581, 2024 02 20.
Article en En | MEDLINE | ID: mdl-38324415
ABSTRACT
Importance Atrial cardiopathy is associated with stroke in the absence of clinically apparent atrial fibrillation. It is unknown whether anticoagulation, which has proven benefit in atrial fibrillation, prevents stroke in patients with atrial cardiopathy and no atrial fibrillation.

Objective:

To compare anticoagulation vs antiplatelet therapy for secondary stroke prevention in patients with cryptogenic stroke and evidence of atrial cardiopathy. Design, Setting, and

Participants:

Multicenter, double-blind, phase 3 randomized clinical trial of 1015 participants with cryptogenic stroke and evidence of atrial cardiopathy, defined as P-wave terminal force greater than 5000 µV × ms in electrocardiogram lead V1, serum N-terminal pro-B-type natriuretic peptide level greater than 250 pg/mL, or left atrial diameter index of 3 cm/m2 or greater on echocardiogram. Participants had no evidence of atrial fibrillation at the time of randomization. Enrollment and follow-up occurred from February 1, 2018, through February 28, 2023, at 185 sites in the National Institutes of Health StrokeNet and the Canadian Stroke Consortium.

Interventions:

Apixaban, 5 mg or 2.5 mg, twice daily (n = 507) vs aspirin, 81 mg, once daily (n = 508). Main Outcomes and

Measures:

The primary efficacy outcome in a time-to-event analysis was recurrent stroke. All participants, including those diagnosed with atrial fibrillation after randomization, were analyzed according to the groups to which they were randomized. The primary safety outcomes were symptomatic intracranial hemorrhage and other major hemorrhage.

Results:

With 1015 of the target 1100 participants enrolled and mean follow-up of 1.8 years, the trial was stopped for futility after a planned interim analysis. The mean (SD) age of participants was 68.0 (11.0) years, 54.3% were female, and 87.5% completed the full duration of follow-up. Recurrent stroke occurred in 40 patients in the apixaban group (annualized rate, 4.4%) and 40 patients in the aspirin group (annualized rate, 4.4%) (hazard ratio, 1.00 [95% CI, 0.64-1.55]). Symptomatic intracranial hemorrhage occurred in 0 patients taking apixaban and 7 patients taking aspirin (annualized rate, 1.1%). Other major hemorrhages occurred in 5 patients taking apixaban (annualized rate, 0.7%) and 5 patients taking aspirin (annualized rate, 0.8%) (hazard ratio, 1.02 [95% CI, 0.29-3.52]). Conclusions and Relevance In patients with cryptogenic stroke and evidence of atrial cardiopathy without atrial fibrillation, apixaban did not significantly reduce recurrent stroke risk compared with aspirin. Trial Registration ClinicalTrials.gov Identifier NCT03192215.
Asunto(s)
Texto completo
Añadir a Mi BVS
Imprimir
XML
PubMed Links
Buscar en Google

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Pirazoles / Fibrilación Atrial / Accidente Cerebrovascular / Accidente Cerebrovascular Isquémico / Cardiopatías Tipo de estudio: Clinical_trials Límite: Aged / Female / Humans / Male País/Región como asunto: America do norte Idioma: En Revista: JAMA Año: 2024 Tipo del documento: Article Pais de publicación: Estados Unidos
Texto completo
Añadir a Mi BVS
Imprimir
XML
PubMed Links
Buscar en Google

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Pirazoles / Fibrilación Atrial / Accidente Cerebrovascular / Accidente Cerebrovascular Isquémico / Cardiopatías Tipo de estudio: Clinical_trials Límite: Aged / Female / Humans / Male País/Región como asunto: America do norte Idioma: En Revista: JAMA Año: 2024 Tipo del documento: Article Pais de publicación: Estados Unidos