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2 PFO closure is superior to medical therapy for cryptogenic stroke: a meta-analysis of randomised controlled trials
  1. Yousif Ahmad1,
  2. James Howard1,
  3. Ahran Arnold1,
  4. Matthew Shun-Shin1,
  5. Christopher Cook1,
  6. Iqbal Malik2,
  7. Jamil Mayet1,
  8. Darrel Francis1,
  9. Sayan Sen1
  1. 1Imperial College London
  2. 2Imperial College Healthcare NHS Trust

Abstract

Background The efficacy of patent foramen ovale (PFO) closure for cryptogenic stroke has been controversial. We undertook a meta-analysis of randomised controlled trials (RCTs) comparing device closure with medical therapy to prevent recurrent stroke for patients with PFO.

Methods and results We systematically identified all RCTs comparing device closure to medical therapy for cryptogenic stroke in patients with PFO. The primary efficacy endpoint was recurrent stroke, analysed on an intention-to-treat basis. The primary safety endpoint was new onset atrial fibrillation (AF).

5 studies (3440 patients) were included. 1829 patients were randomised to device closure and 1611 to medical therapy. PFO closure was superior to medical therapy for prevention of stroke (HR 0.32 (0.13–0.82), p=0.018, I2=73.4%). The risk of AF was significantly increased with device closure (RR 4.54, 95% CI 2.17 to 9.48, p<0.001, heterogeneity I2=22.9%).

Conclusion In patients with cryptogenic stroke and PFO, device closure is superior to medical therapy for the prevention of further stroke.

  • PFO
  • Stroke
  • PFO closure

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