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Abstract
Objective To compare the outcomes of patent foramen ovale (PFO) closure vs antiplatelet agent (APA) vs oral anticoagulation therapy (OAT) for secondary prevention of stroke in patients with cryptogenic stroke, using direct and indirect evidence from existing randomized data.
Methods Relevant randomized controlled trials were identified by a systematic review. The efficacy outcome was stroke recurrence, and safety outcomes were atrial fibrillation and bleeding complications at the end of follow-up. Bayesian network meta-analysis was performed to calculate risk estimates and the rank probabilities using APA therapy as the reference.
Results In a network meta-analysis of 6 randomized controlled trials consisting of 3,497 patients (1,732 PFO closure, 1,252 APA, 513 OAT), PFO closure and OAT were associated with lower rates of recurrent stroke (odds ratio [OR] 0.30, 95% credibility interval [CrI] 0.17–0.49 and OR 0.42, 95% CrI 0.22–0.78, respectively) with equal efficacy of OR 0.70 (95% CrI 0.37–1.49). PFO closure had the highest top rank probability of atrial fibrillation and OAT had the highest risk of bleeding complications.
Conclusions These findings suggest that closure and OAT may be equally effective in recurrent stroke prevention in patients with PFO. There is an increased risk of atrial fibrillation and bleeding with closure and OAT therapy, respectively. A randomized trial is needed to identify patients who would benefit most from each strategy.
Glossary
- APA=
- antiplatelet agent;
- CI=
- confidence interval;
- CLOSE=
- Patent Foramen Ovale Closure or Anticoagulants Versus Antiplatelet Therapy to Prevent Stroke Recurrence;
- CLOSURE I=
- Evaluation of the STARFlex Septal Closure System in Patients with a Stroke and/or Transient Ischemic Attack due to Presumed Paradoxical Embolism Through a Patent Foramen Ovale;
- CrI=
- credibility interval;
- GORE REDUCE=
- GORE HELEX Septal Occluder/GORE CARDIOFORM Septal Occluder and Antiplatelet Medical Management for Reduction of Recurrent Stroke or Imaging-Confirmed TIA in Patients with Patent Foramen Ovale (PFO);
- HR=
- hazard ratio;
- NMA=
- network meta-analysis;
- OAT=
- oral anticoagulation therapy;
- OR=
- odds ratio;
- PC=
- Clinical Trial Comparing Percutaneous Closure of Patent Foramen Ovale (PFO) Using the Amplatzer PFO Occluder with Medical Treatment in Patients with Cryptogenic Embolism;
- PFO=
- patent foramen ovale;
- PICSS=
- Patent Foramen Ovale in Cryptogenic Stroke Study;
- PRISMA=
- Preferred Reporting Items for Systematic Reviews and Meta-Analyses;
- RCT=
- randomized controlled trial;
- RESPECT=
- Randomized Evaluation of Recurrent Stroke Comparing PFO Closure to Established Current Standard of Care Treatment
Footnotes
Go to Neurology.org/N for full disclosures. Funding information and disclosures deemed relevant by the authors, if any, are provided at the end of the article.
Editorial, page 14
See page e8
- Received November 19, 2017.
- Accepted in final form April 5, 2018.
- © 2018 American Academy of Neurology
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