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Cardiovasc Revasc Med. 2013 Nov-Dec;14(6):349-55. doi: 10.1016/j.carrev.2013.08.010. Epub 2013 Sep 27.

Safety and efficacy of device closure for patent foramen ovale for secondary prevention of neurological events: Comprehensive systematic review and meta-analysis of randomized controlled trials.

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1
University of Arkansas for Medical Sciences, Little Rock, AR, USA.

Abstract

BACKGROUND:

Controversy persists regarding the management of patients with cryptogenic stroke and patent foramen ovale (PFO). We performed a meta-analysis of randomized controlled trials comparing PFO closure with medical therapy.

METHODS AND RESULTS:

A prospective protocol was developed and registered using the following data sources: PubMed, Cochrane Register of Controlled Trials, conference proceedings, and Internet-based resources of clinical trials. Primary analyses were performed using the intention-to-treat method. Three randomized trials comparing percutaneous PFO closure vs. medical therapy for secondary prevention of embolic neurological events formed the data set. Baseline characteristics were similar. During long-term follow-up, the pooled incidence of the primary endpoint (composite of stroke, death, or fatal stroke) was 3.4% in the PFO closure arm and 4.8% in the medical therapy group [risk-reduction (RR) 0.7 (0.48-1.06); p=0.09]. The incidence of recurrent neurological events (secondary endpoint) was 1.7% for PFO closure and 2.7% for medical therapy [RR 0.66 (0.35-1.24), p=0.19]. There was no difference in terms of death or adverse events between the two groups.

CONCLUSIONS:

While this meta-analysis of randomized clinical trials demonstrated no statistical significance in comparison to medical therapy, there was a trend towards overall improvement in outcomes in the PFO closure group.

KEYWORDS:

Meta-analysis; Patent foramen ovale; Structural interventions

PMID:
24080379
DOI:
10.1016/j.carrev.2013.08.010
[Indexed for MEDLINE]
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