Abstract
Objectives: To systematically review and perform a meta-analysis of randomized controlled trials(RCT) comparing percutaneous closure of patent foramen ovale(PFO) to medical therapy in patients with cryptogenic stroke or transient ischemic attack(TIA). Background: Up to 61% of patients with cryptogenic stroke under the age of 55 years have been found to have a PFO. Observational studies have demonstrated reductions in recurrent, neurologic events with PFO closure compared to medical therapy. Recent RCT have shown non-significant trends toward benefit. Methods: We systematically searched for RCT of percutaneous PFO closure versus antiplatelet or anticoagulation medical therapy in patients with cryptogenic stroke or TIA and performed a meta-analysis of treatment outcomes. The primary end point was combined death, stroke, or TIA as defined by each study. Results: Three RCT of 2303 patients were included. In all, 1150 patients underwent PFO closure and 1153 received medical therapy and were followed over a median of 2.6(2.0-4.1) years. The pooled incidence of the primary end point was 1.2(95% confidence interval:0.2-2.3) events/100 patient-years in the PFO closure group and 1.8(0.7-2.9) in the medical therapy group(p=0.32), with a number needed to treat(NNT) of 167(100-500). The corresponding pooled hazard ratio(HR) was 0.67(0.44-1.01,p=0.054) in favor of PFO closure. PFO closure was associated with an increased incidence of atrial fibrillation, relative risk =3.51(1.44-8.55,p=0.006). When stratified by device, the Amplatzer™ showed a significant stroke prevention benefit, HR=0.44(0.21-0.95,p=0.037). Conclusions: In comparison to medical therapy alone, PFO closure trends toward decreased hazard of combined events, although the absolute event reduction is small with a high NNT in the population studied.
Published Version
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