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Patent Foramen Ovale Closure in Older Patients With Stroke: Patient Selection for Trial Feasibility.
Wang, Andy Y; Rothwell, Peter M; Nelson, Jason; Saver, Jeffrey L; Kasner, Scott E; Carroll, John; Mas, Jean-Louis; Derumeaux, Geneviève; Chatellier, Gilles; Furlan, Anthony J; Herrmann, Howard C; Jüni, Peter; Kim, Jong S; Koethe, Benjamin; Lee, Pil H; Lefebvre, Benedicte; Mattle, Heinrich P; Meier, Bernhard; Reisman, Mark; Smalling, Richard W; Sondergaard, Lars; Song, Jae-Kwan; Di Angelantonio, Emanuele; DiTullio, Marco; Elkind, Mitchell S V; Homma, Shunichi; Jaigobin, Cheryl; Michel, Patrik; Mono, Marie-Luise; Nedeltchev, Krassen; Papetti, Federica; Serena, Joaquin; Weimar, Christian; Li, Linxin; Mazzucco, Sara; Silver, Louise E; van Klaveren, David; Thaler, David E; Kent, David M.
Afiliación
  • Wang AY; From the Predictive Analytics and Comparative Effectiveness (PACE) Center (A.Y.W., J.N., B.K., D.K., D.M.K.), Institute for Clinical Research and Health Policy Studies (ICRHPS), Tufts Medical Center, Boston, MA; Department of Clinical Neurology (P.M.R., L.L., S.M., L.E.S.), Oxford University, London
  • Rothwell PM; From the Predictive Analytics and Comparative Effectiveness (PACE) Center (A.Y.W., J.N., B.K., D.K., D.M.K.), Institute for Clinical Research and Health Policy Studies (ICRHPS), Tufts Medical Center, Boston, MA; Department of Clinical Neurology (P.M.R., L.L., S.M., L.E.S.), Oxford University, London
  • Nelson J; From the Predictive Analytics and Comparative Effectiveness (PACE) Center (A.Y.W., J.N., B.K., D.K., D.M.K.), Institute for Clinical Research and Health Policy Studies (ICRHPS), Tufts Medical Center, Boston, MA; Department of Clinical Neurology (P.M.R., L.L., S.M., L.E.S.), Oxford University, London
  • Saver JL; From the Predictive Analytics and Comparative Effectiveness (PACE) Center (A.Y.W., J.N., B.K., D.K., D.M.K.), Institute for Clinical Research and Health Policy Studies (ICRHPS), Tufts Medical Center, Boston, MA; Department of Clinical Neurology (P.M.R., L.L., S.M., L.E.S.), Oxford University, London
  • Kasner SE; From the Predictive Analytics and Comparative Effectiveness (PACE) Center (A.Y.W., J.N., B.K., D.K., D.M.K.), Institute for Clinical Research and Health Policy Studies (ICRHPS), Tufts Medical Center, Boston, MA; Department of Clinical Neurology (P.M.R., L.L., S.M., L.E.S.), Oxford University, London
  • Carroll J; From the Predictive Analytics and Comparative Effectiveness (PACE) Center (A.Y.W., J.N., B.K., D.K., D.M.K.), Institute for Clinical Research and Health Policy Studies (ICRHPS), Tufts Medical Center, Boston, MA; Department of Clinical Neurology (P.M.R., L.L., S.M., L.E.S.), Oxford University, London
  • Mas JL; From the Predictive Analytics and Comparative Effectiveness (PACE) Center (A.Y.W., J.N., B.K., D.K., D.M.K.), Institute for Clinical Research and Health Policy Studies (ICRHPS), Tufts Medical Center, Boston, MA; Department of Clinical Neurology (P.M.R., L.L., S.M., L.E.S.), Oxford University, London
  • Derumeaux G; From the Predictive Analytics and Comparative Effectiveness (PACE) Center (A.Y.W., J.N., B.K., D.K., D.M.K.), Institute for Clinical Research and Health Policy Studies (ICRHPS), Tufts Medical Center, Boston, MA; Department of Clinical Neurology (P.M.R., L.L., S.M., L.E.S.), Oxford University, London
  • Chatellier G; From the Predictive Analytics and Comparative Effectiveness (PACE) Center (A.Y.W., J.N., B.K., D.K., D.M.K.), Institute for Clinical Research and Health Policy Studies (ICRHPS), Tufts Medical Center, Boston, MA; Department of Clinical Neurology (P.M.R., L.L., S.M., L.E.S.), Oxford University, London
  • Furlan AJ; From the Predictive Analytics and Comparative Effectiveness (PACE) Center (A.Y.W., J.N., B.K., D.K., D.M.K.), Institute for Clinical Research and Health Policy Studies (ICRHPS), Tufts Medical Center, Boston, MA; Department of Clinical Neurology (P.M.R., L.L., S.M., L.E.S.), Oxford University, London
  • Herrmann HC; From the Predictive Analytics and Comparative Effectiveness (PACE) Center (A.Y.W., J.N., B.K., D.K., D.M.K.), Institute for Clinical Research and Health Policy Studies (ICRHPS), Tufts Medical Center, Boston, MA; Department of Clinical Neurology (P.M.R., L.L., S.M., L.E.S.), Oxford University, London
  • Jüni P; From the Predictive Analytics and Comparative Effectiveness (PACE) Center (A.Y.W., J.N., B.K., D.K., D.M.K.), Institute for Clinical Research and Health Policy Studies (ICRHPS), Tufts Medical Center, Boston, MA; Department of Clinical Neurology (P.M.R., L.L., S.M., L.E.S.), Oxford University, London
  • Kim JS; From the Predictive Analytics and Comparative Effectiveness (PACE) Center (A.Y.W., J.N., B.K., D.K., D.M.K.), Institute for Clinical Research and Health Policy Studies (ICRHPS), Tufts Medical Center, Boston, MA; Department of Clinical Neurology (P.M.R., L.L., S.M., L.E.S.), Oxford University, London
  • Koethe B; From the Predictive Analytics and Comparative Effectiveness (PACE) Center (A.Y.W., J.N., B.K., D.K., D.M.K.), Institute for Clinical Research and Health Policy Studies (ICRHPS), Tufts Medical Center, Boston, MA; Department of Clinical Neurology (P.M.R., L.L., S.M., L.E.S.), Oxford University, London
  • Lee PH; From the Predictive Analytics and Comparative Effectiveness (PACE) Center (A.Y.W., J.N., B.K., D.K., D.M.K.), Institute for Clinical Research and Health Policy Studies (ICRHPS), Tufts Medical Center, Boston, MA; Department of Clinical Neurology (P.M.R., L.L., S.M., L.E.S.), Oxford University, London
  • Lefebvre B; From the Predictive Analytics and Comparative Effectiveness (PACE) Center (A.Y.W., J.N., B.K., D.K., D.M.K.), Institute for Clinical Research and Health Policy Studies (ICRHPS), Tufts Medical Center, Boston, MA; Department of Clinical Neurology (P.M.R., L.L., S.M., L.E.S.), Oxford University, London
  • Mattle HP; From the Predictive Analytics and Comparative Effectiveness (PACE) Center (A.Y.W., J.N., B.K., D.K., D.M.K.), Institute for Clinical Research and Health Policy Studies (ICRHPS), Tufts Medical Center, Boston, MA; Department of Clinical Neurology (P.M.R., L.L., S.M., L.E.S.), Oxford University, London
  • Meier B; From the Predictive Analytics and Comparative Effectiveness (PACE) Center (A.Y.W., J.N., B.K., D.K., D.M.K.), Institute for Clinical Research and Health Policy Studies (ICRHPS), Tufts Medical Center, Boston, MA; Department of Clinical Neurology (P.M.R., L.L., S.M., L.E.S.), Oxford University, London
  • Reisman M; From the Predictive Analytics and Comparative Effectiveness (PACE) Center (A.Y.W., J.N., B.K., D.K., D.M.K.), Institute for Clinical Research and Health Policy Studies (ICRHPS), Tufts Medical Center, Boston, MA; Department of Clinical Neurology (P.M.R., L.L., S.M., L.E.S.), Oxford University, London
  • Smalling RW; From the Predictive Analytics and Comparative Effectiveness (PACE) Center (A.Y.W., J.N., B.K., D.K., D.M.K.), Institute for Clinical Research and Health Policy Studies (ICRHPS), Tufts Medical Center, Boston, MA; Department of Clinical Neurology (P.M.R., L.L., S.M., L.E.S.), Oxford University, London
  • Sondergaard L; From the Predictive Analytics and Comparative Effectiveness (PACE) Center (A.Y.W., J.N., B.K., D.K., D.M.K.), Institute for Clinical Research and Health Policy Studies (ICRHPS), Tufts Medical Center, Boston, MA; Department of Clinical Neurology (P.M.R., L.L., S.M., L.E.S.), Oxford University, London
  • Song JK; From the Predictive Analytics and Comparative Effectiveness (PACE) Center (A.Y.W., J.N., B.K., D.K., D.M.K.), Institute for Clinical Research and Health Policy Studies (ICRHPS), Tufts Medical Center, Boston, MA; Department of Clinical Neurology (P.M.R., L.L., S.M., L.E.S.), Oxford University, London
  • Di Angelantonio E; From the Predictive Analytics and Comparative Effectiveness (PACE) Center (A.Y.W., J.N., B.K., D.K., D.M.K.), Institute for Clinical Research and Health Policy Studies (ICRHPS), Tufts Medical Center, Boston, MA; Department of Clinical Neurology (P.M.R., L.L., S.M., L.E.S.), Oxford University, London
  • DiTullio M; From the Predictive Analytics and Comparative Effectiveness (PACE) Center (A.Y.W., J.N., B.K., D.K., D.M.K.), Institute for Clinical Research and Health Policy Studies (ICRHPS), Tufts Medical Center, Boston, MA; Department of Clinical Neurology (P.M.R., L.L., S.M., L.E.S.), Oxford University, London
  • Elkind MSV; From the Predictive Analytics and Comparative Effectiveness (PACE) Center (A.Y.W., J.N., B.K., D.K., D.M.K.), Institute for Clinical Research and Health Policy Studies (ICRHPS), Tufts Medical Center, Boston, MA; Department of Clinical Neurology (P.M.R., L.L., S.M., L.E.S.), Oxford University, London
  • Homma S; From the Predictive Analytics and Comparative Effectiveness (PACE) Center (A.Y.W., J.N., B.K., D.K., D.M.K.), Institute for Clinical Research and Health Policy Studies (ICRHPS), Tufts Medical Center, Boston, MA; Department of Clinical Neurology (P.M.R., L.L., S.M., L.E.S.), Oxford University, London
  • Jaigobin C; From the Predictive Analytics and Comparative Effectiveness (PACE) Center (A.Y.W., J.N., B.K., D.K., D.M.K.), Institute for Clinical Research and Health Policy Studies (ICRHPS), Tufts Medical Center, Boston, MA; Department of Clinical Neurology (P.M.R., L.L., S.M., L.E.S.), Oxford University, London
  • Michel P; From the Predictive Analytics and Comparative Effectiveness (PACE) Center (A.Y.W., J.N., B.K., D.K., D.M.K.), Institute for Clinical Research and Health Policy Studies (ICRHPS), Tufts Medical Center, Boston, MA; Department of Clinical Neurology (P.M.R., L.L., S.M., L.E.S.), Oxford University, London
  • Mono ML; From the Predictive Analytics and Comparative Effectiveness (PACE) Center (A.Y.W., J.N., B.K., D.K., D.M.K.), Institute for Clinical Research and Health Policy Studies (ICRHPS), Tufts Medical Center, Boston, MA; Department of Clinical Neurology (P.M.R., L.L., S.M., L.E.S.), Oxford University, London
  • Nedeltchev K; From the Predictive Analytics and Comparative Effectiveness (PACE) Center (A.Y.W., J.N., B.K., D.K., D.M.K.), Institute for Clinical Research and Health Policy Studies (ICRHPS), Tufts Medical Center, Boston, MA; Department of Clinical Neurology (P.M.R., L.L., S.M., L.E.S.), Oxford University, London
  • Papetti F; From the Predictive Analytics and Comparative Effectiveness (PACE) Center (A.Y.W., J.N., B.K., D.K., D.M.K.), Institute for Clinical Research and Health Policy Studies (ICRHPS), Tufts Medical Center, Boston, MA; Department of Clinical Neurology (P.M.R., L.L., S.M., L.E.S.), Oxford University, London
  • Serena J; From the Predictive Analytics and Comparative Effectiveness (PACE) Center (A.Y.W., J.N., B.K., D.K., D.M.K.), Institute for Clinical Research and Health Policy Studies (ICRHPS), Tufts Medical Center, Boston, MA; Department of Clinical Neurology (P.M.R., L.L., S.M., L.E.S.), Oxford University, London
  • Weimar C; From the Predictive Analytics and Comparative Effectiveness (PACE) Center (A.Y.W., J.N., B.K., D.K., D.M.K.), Institute for Clinical Research and Health Policy Studies (ICRHPS), Tufts Medical Center, Boston, MA; Department of Clinical Neurology (P.M.R., L.L., S.M., L.E.S.), Oxford University, London
  • Li L; From the Predictive Analytics and Comparative Effectiveness (PACE) Center (A.Y.W., J.N., B.K., D.K., D.M.K.), Institute for Clinical Research and Health Policy Studies (ICRHPS), Tufts Medical Center, Boston, MA; Department of Clinical Neurology (P.M.R., L.L., S.M., L.E.S.), Oxford University, London
  • Mazzucco S; From the Predictive Analytics and Comparative Effectiveness (PACE) Center (A.Y.W., J.N., B.K., D.K., D.M.K.), Institute for Clinical Research and Health Policy Studies (ICRHPS), Tufts Medical Center, Boston, MA; Department of Clinical Neurology (P.M.R., L.L., S.M., L.E.S.), Oxford University, London
  • Silver LE; From the Predictive Analytics and Comparative Effectiveness (PACE) Center (A.Y.W., J.N., B.K., D.K., D.M.K.), Institute for Clinical Research and Health Policy Studies (ICRHPS), Tufts Medical Center, Boston, MA; Department of Clinical Neurology (P.M.R., L.L., S.M., L.E.S.), Oxford University, London
  • van Klaveren D; From the Predictive Analytics and Comparative Effectiveness (PACE) Center (A.Y.W., J.N., B.K., D.K., D.M.K.), Institute for Clinical Research and Health Policy Studies (ICRHPS), Tufts Medical Center, Boston, MA; Department of Clinical Neurology (P.M.R., L.L., S.M., L.E.S.), Oxford University, London
  • Thaler DE; From the Predictive Analytics and Comparative Effectiveness (PACE) Center (A.Y.W., J.N., B.K., D.K., D.M.K.), Institute for Clinical Research and Health Policy Studies (ICRHPS), Tufts Medical Center, Boston, MA; Department of Clinical Neurology (P.M.R., L.L., S.M., L.E.S.), Oxford University, London
  • Kent DM; From the Predictive Analytics and Comparative Effectiveness (PACE) Center (A.Y.W., J.N., B.K., D.K., D.M.K.), Institute for Clinical Research and Health Policy Studies (ICRHPS), Tufts Medical Center, Boston, MA; Department of Clinical Neurology (P.M.R., L.L., S.M., L.E.S.), Oxford University, London
Neurology ; 102(10): e209388, 2024 May 28.
Article en En | MEDLINE | ID: mdl-38701403
ABSTRACT
BACKGROUND AND

OBJECTIVES:

Whether patent foramen ovale (PFO) closure benefits older patients with PFO and cryptogenic stroke is unknown because randomized controlled trials (RCTs) have predominantly enrolled patients younger than 60 years of age. Our objective was to estimate anticipated effects of PFO closure in older patients to predict the numbers needed to plan an RCT.

METHODS:

Effectiveness estimates are derived from major observational studies (Risk of Paradoxical Embolism [RoPE] Study and Oxford Vascular Study, together referred to as the "RoPE-Ox" database) and all 6 major RCTs (Systematic, Collaborative, PFO Closure Evaluation [SCOPE] Consortium). To estimate stroke recurrence risk, observed outcomes were calculated for patients older than 60 years in the age-inclusive observational databases (n = 549). To estimate the reduction in the rate of recurrent stroke associated with PFO closure vs medical therapy based on the RoPE score and the presence of high-risk PFO features, a Cox proportional hazards regression model was developed on the RCT data in the SCOPE database (n = 3,740). These estimates were used to calculate sample sizes required for a future RCT.

RESULTS:

Five-year risk of stroke recurrence using Kaplan-Meier estimates was 13.7 (95% CI 10.5-17.9) overall, 14.9% (95% CI 10.2-21.6) in those with high-risk PFO features. Predicted relative reduction in the event rate with PFO closure was 12.9% overall, 48.8% in those with a high-risk PFO feature. Using these estimates, enrolling all older patients with cryptogenic stroke and PFO would require much larger samples than those used for prior PFO closure trials, but selectively enrolling patients with high-risk PFO features would require totals of 630 patients for 90% power and 471 patients for 80% power, with an average of 5 years of follow-up.

DISCUSSION:

Based on our projections, anticipated effect sizes in older patients with high-risk features make a trial in these subjects feasible. With lengthening life expectancy in almost all regions of the world, the utility of PFO closure in older adults is increasingly important to explore.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Estudios de Factibilidad / Selección de Paciente / Accidente Cerebrovascular / Foramen Oval Permeable Límite: Aged / Aged80 / Female / Humans / Male / Middle aged Idioma: En Revista: Neurology Año: 2024 Tipo del documento: Article
Texto completo
Añadir a Mi BVS
Imprimir
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Buscar en Google

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Estudios de Factibilidad / Selección de Paciente / Accidente Cerebrovascular / Foramen Oval Permeable Límite: Aged / Aged80 / Female / Humans / Male / Middle aged Idioma: En Revista: Neurology Año: 2024 Tipo del documento: Article