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J Am Heart Assoc. 2018 Jun 17;7(12). pii: e008356. doi: 10.1161/JAHA.117.008356.

Closure, Anticoagulation, or Antiplatelet Therapy for Cryptogenic Stroke With Patent Foramen Ovale: Systematic Review of Randomized Trials, Sequential Meta-Analysis, and New Insights From the CLOSE Study.

Turc G1,2,3,4, Calvet D1,2,3,4, Guérin P5,6, Sroussi M2,7, Chatellier G2,8,9, Mas JL10,2,3,4; CLOSE Investigators.

Author information

1
Department of Neurology, Hôpital Sainte-Anne, Paris, France.
2
Université Paris Descartes Sorbonne Paris Cité, Paris, France.
3
NSERM U894, Paris, France.
4
DHU Neurovasc, Paris, France.
5
Department of Cardiology, INSERM UMR 915 Institut du Thorax, Nantes, France.
6
Institut du Thorax, Centre Hospitalier Universitaire de Nantes, Nantes, France.
7
Department of Cardiology, Cochin Hospital APHP, Paris, France.
8
Epidemiology and Clinical Research Unit, Georges Pompidou European Hospital APHP, Paris, France.
9
INSERM CIC 1418, Paris, France.
10
Department of Neurology, Hôpital Sainte-Anne, Paris, France jl.mas@ch-sainte-anne.fr.

Abstract

BACKGROUND:

We conducted a systematic review and meta-analysis of randomized controlled trials (RCTs) comparing patent foramen ovale (PFO) closure, anticoagulation, and antiplatelet therapy to prevent stroke recurrence in patients with PFO-associated cryptogenic stroke.

METHODS AND RESULTS:

We searched Medline, Cochrane Library, and EMBASE through March 2018. The primary outcome was stroke recurrence. Pooled incidences, hazard ratios, and risk ratios (RRs) were calculated in random-effects meta-analyses. PFO closure was associated with a lower risk of recurrent stroke compared with antithrombotic therapy (antiplatelet therapy or anticoagulation: 3560 patients from 6 RCTs; RR=0.36, 95% CI: 0.17-0.79; I2=59%). The effect of PFO closure on stroke recurrence was larger in patients with atrial septal aneurysm or large shunt (RR=0.27, 95% CI, 0.11-0.70; I2=42%) compared with patients without these anatomical features (RR=0.80, 95% CI, 0.43-1.47; I2=12%). Major complications occurred in 2.40% (95% CI, 1.03-4.25; I2=77%) of procedures. New-onset atrial fibrillation was more frequent in patients randomized to PFO closure versus antithrombotic therapy (RR=4.33, 95% CI, 2.37-7.89; I2=14%). One RCT compared PFO closure versus anticoagulation (353 patients; hazard ratio=0.14, 95% CI, 0.00-1.45) and 2 RCTs compared PFO closure versus antiplatelet therapy (1137 patients; hazard ratio=0.18, 95% CI, 0.05-0.63; I2=12%). Three RCTs compared anticoagulation versus antiplatelet therapy, with none showing a significant difference.

CONCLUSIONS:

PFO closure is superior to antithrombotic therapy to prevent stroke recurrence after cryptogenic stroke. The annual absolute risk reduction of stroke was low, but it has to be tempered by a substantial time at risk (at least 5 years) in young and middle-aged patients. PFO closure was associated with an increased risk of atrial fibrillation.

KEYWORDS:

anticoagulation; patent foramen ovale; patent foramen ovale closure; stroke

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