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Updated: Dec 23, 2025

Closure of a Patent Foramen Ovale PFO: An Intervention Sequence
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Closure of a Patent Foramen Ovale PFO: An Intervention Sequence

Published on: December 23, 2022

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Aspirin or anticoagulation after cryptogenic stroke with patent foramen ovale: systematic review and meta-analysis of

Michele Romoli1,2, David Giannandrea3, Paolo Eusebi4

  • 1Neurology Unit, Rimini "Infermi" Hospital - AUSL Romagna, Rimini, Italy. michele.romoli@auslromagna.it.

Neurological Sciences : Official Journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology
|April 20, 2020
PubMed

Insights

Anticoagulation does not offer a net benefit over antiplatelet therapy for preventing recurrent stroke in patients with patent foramen ovale (PFO). However, the Risk of Paradoxical Embolism (RoPE) score may help identify patients who could benefit from anticoagulation.

Area of Science:

  • Cardiology
  • Neurology
  • Clinical Trials

Background:

  • Patent foramen ovale (PFO) is associated with cryptogenic stroke, but closure has strict eligibility criteria.
  • Most patients with PFO-related stroke receive medical management, yet optimal antithrombotic strategy remains uncertain.
  • This study addresses the need to define the risk-benefit profile of anticoagulation versus antiplatelet therapy.

Purpose of the Study:

  • To conduct a systematic review and meta-analysis of randomized controlled trials (RCTs).
  • To compare the efficacy and safety of anticoagulation versus antiplatelet treatment in patients with PFO-related stroke.
  • To explore the role of the Risk of Paradoxical Embolism (RoPE) score in patient selection.

Main Methods:

  • Systematic review and meta-analysis adhering to PRISMA guidelines.
  • Searched MEDLINE, EMBASE, and Cochrane CENTRAL databases (2000-2019) for relevant RCTs.
  • Assessed risk of bias using the Cochrane RoB tool; analyzed stroke recurrence and major bleeding as primary outcomes.

Main Results:

  • Five RCTs involving 1565 patients were included; 48.1% received anticoagulation.
  • Anticoagulation showed no significant benefit in preventing recurrent stroke compared to antiplatelet therapy (OR=0.66, 95% CI 0.41-1.07).
  • Anticoagulation was associated with a non-significant increase in major bleeding risk (OR=1.64, 95% CI 0.79-3.43).
  • In patients with a high RoPE score, anticoagulation significantly reduced recurrent stroke risk (OR=0.22, 95% CI 0.06-0.8).

Conclusions:

  • Current meta-analysis indicates anticoagulation offers no net benefit over antiplatelets for stroke prevention in PFO patients.
  • The RoPE score may aid in identifying subgroups of patients who could potentially benefit from anticoagulation.
  • Further research is required to fully elucidate the risk-benefit profile of anticoagulation in selected PFO-related stroke patients.
Abstract

Keywords:
AspirinDabigatranPatent foramen ovaleRivaroxabanStroke

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