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Closure of a Patent Foramen Ovale (PFO): An Intervention Sequence
10:52

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

Published on: December 23, 2022

Closure of patent foramen ovale versus medical therapy after cryptogenic stroke

John D Carroll1, Jeffrey L Saver, David E Thaler

  • 1University of Colorado Denver/University of Colorado Hospital, Aurora, CO 80045, USA. john.carroll@ucdenver.edu

The New England Journal of Medicine
|March 22, 2013
PubMed

Insights

Closure of a patent foramen ovale (PFO) did not show significant benefit in preventing recurrent ischemic stroke in the primary analysis. However, PFO closure proved superior to medical therapy alone in secondary analyses for cryptogenic stroke patients.

Area of Science:

  • Cardiology
  • Neurology
  • Medical Devices

Background:

  • Cryptogenic stroke affects patients without a clear cause.
  • Patent foramen ovale (PFO) is a potential, yet unproven, cause of cryptogenic stroke.
  • The efficacy of PFO closure versus medical therapy for stroke prevention remains uncertain.

Purpose of the Study:

  • To evaluate if PFO closure is superior to medical therapy alone in preventing recurrent ischemic stroke.
  • To assess the safety and efficacy in patients aged 18-60 with cryptogenic stroke.

Main Methods:

  • A prospective, multicenter, randomized, event-driven trial.
  • 980 patients were randomized 1:1 to medical therapy alone or PFO closure.
  • Primary results analyzed upon reaching 25 primary endpoint events.

Main Results:

  • In the intention-to-treat analysis, PFO closure did not significantly reduce recurrent stroke (HR 0.49, P=0.08).
  • Per-protocol (HR 0.37, P=0.03) and as-treated (HR 0.27, P=0.007) analyses showed significant stroke reduction with PFO closure.
  • Adverse events were similar between groups; procedure-related events were low (4.2%).

Conclusions:

  • PFO closure showed no significant benefit in the primary intention-to-treat analysis for cryptogenic stroke.
  • However, PFO closure demonstrated superiority in per-protocol and as-treated analyses.
  • PFO closure is associated with a low rate of risks when compared to medical therapy alone.
Abstract

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