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Article Dans Une Revue Neurology Année : 2024

Patent Foramen Ovale Closure in Older Patients With Stroke

Andy Wang
  • Fonction : Auteur
Peter Rothwell
Jason Nelson
  • Fonction : Auteur
Jeffrey Saver
Scott Kasner
  • Fonction : Auteur
John Carroll
  • Fonction : Auteur
Geneviève Derumeaux
  • Fonction : Auteur
Gilles Chatellier
  • Fonction : Auteur
Anthony Furlan
  • Fonction : Auteur
Howard Herrmann
Peter Jüni
  • Fonction : Auteur
Jong Kim
  • Fonction : Auteur
Benjamin Koethe
  • Fonction : Auteur
Pil Lee
  • Fonction : Auteur
Benedicte Lefebvre
  • Fonction : Auteur
Heinrich Mattle
  • Fonction : Auteur
Bernhard Meier
  • Fonction : Auteur
Mark Reisman
  • Fonction : Auteur
Richard Smalling
Lars Sondergaard
  • Fonction : Auteur
Jae-Kwan Song
  • Fonction : Auteur
Emanuele Di Angelantonio
  • Fonction : Auteur
Marco Ditullio
Mitchell Elkind
  • Fonction : Auteur
Shunichi Homma
  • Fonction : Auteur
Cheryl Jaigobin
  • Fonction : Auteur
Patrik Michel
Marie-Luise Mono
Krassen Nedeltchev
  • Fonction : Auteur
Federica Papetti
  • Fonction : Auteur
Joaquin Serena
Christian Weimar
  • Fonction : Auteur
Linxin Li
Sara Mazzucco
Louise Silver
  • Fonction : Auteur
David van Klaveren
  • Fonction : Auteur
David Thaler
  • Fonction : Auteur
David Kent
  • Fonction : Auteur
Mitchell S.V. Elkind

Résumé

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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Dates et versions

hal-04601005 , version 1 (04-06-2024)

Identifiants

Citer

Andy Wang, Peter Rothwell, Jason Nelson, Jeffrey Saver, Scott Kasner, et al.. Patent Foramen Ovale Closure in Older Patients With Stroke. Neurology, 2024, 102 (10), pp.e209388. ⟨10.1212/WNL.0000000000209388⟩. ⟨hal-04601005⟩

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