TY - JOUR
T1 - Safety and efficacy of device closure for patent foramen ovale for secondary prevention of neurological events
T2 - Comprehensive systematic review and meta-analysis of randomized controlled trials
AU - Hakeem, Abdul
AU - Marmagkiolis, Konstantinos
AU - Hacioglu, Yalcin
AU - Uretsky, Barry F.
AU - Gundogdu, Betul
AU - Leesar, Massoud
AU - Bailey, Steven R.
AU - Cilingiroglu, Mehmet
PY - 2013/11/1
Y1 - 2013/11/1
N2 - 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.
AB - 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.
KW - Meta-analysis
KW - Patent foramen ovale
KW - Structural interventions
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U2 - 10.1016/j.carrev.2013.08.010
DO - 10.1016/j.carrev.2013.08.010
M3 - Review article
C2 - 24080379
AN - SCOPUS:84888202807
VL - 14
SP - 349
EP - 355
JO - Cardiovascular Revascularization Medicine
JF - Cardiovascular Revascularization Medicine
SN - 1553-8389
IS - 6
ER -