Georgios Tsivgoulis1, Aristeidis H Katsanos2, Dimitris Mavridis2, Alexandra Frogoudaki2, Agathi-Rosa Vrettou2, Ignatios Ikonomidis2, John Parissis2, Spyridon Deftereos2, Theodore Karapanayiotides2, Lina Palaiodimou2, Angeliki Filippatou2, Fabienne Perren2, Georgios Hadjigeorgiou2, Anne W Alexandrov2, Panayiotis D Mitsias2, Andrei V Alexandrov2. 1. From the Second Department of Neurology (G.T., A.H.K., L.P., A. Filippatou) and Second Department of Cardiology (A. Frogoudaki, A.-R.V., I.I., J.P., S.D.), Attikon University Hospital, School of Medicine, National and Kapodistrian University of Athens, Greece; Department of Neurology (G.T., A.W.A., A.V.A.), University of Tennessee Health Science Center, Memphis; Departments of Neurology (A.H.K.) and Hygiene and Epidemiology (D.M.), School of Medicine, and Department of Primary Education (D.M.), University of Ioannina; Second Department of Neurology (T.K.), Aristotle University of Thessaloniki, AHEPA University Hospital, Thessaloniki, Greece; Department of Neurology (F.P.), University Hospital of Geneva, Switzerland; Department of Neurology (G.H.), University of Thessaly, Larissa; and Department of Neurology (P.D.M.), School of Medicine, University of Crete, Heraklion, Greece. tsivgoulisgiorg@yahoo.gr. 2. From the Second Department of Neurology (G.T., A.H.K., L.P., A. Filippatou) and Second Department of Cardiology (A. Frogoudaki, A.-R.V., I.I., J.P., S.D.), Attikon University Hospital, School of Medicine, National and Kapodistrian University of Athens, Greece; Department of Neurology (G.T., A.W.A., A.V.A.), University of Tennessee Health Science Center, Memphis; Departments of Neurology (A.H.K.) and Hygiene and Epidemiology (D.M.), School of Medicine, and Department of Primary Education (D.M.), University of Ioannina; Second Department of Neurology (T.K.), Aristotle University of Thessaloniki, AHEPA University Hospital, Thessaloniki, Greece; Department of Neurology (F.P.), University Hospital of Geneva, Switzerland; Department of Neurology (G.H.), University of Thessaly, Larissa; and Department of Neurology (P.D.M.), School of Medicine, University of Crete, Heraklion, Greece.
Abstract
OBJECTIVE: Current guidelines report no benefit for patent foramen ovale (PFO) closure compared to medical treatment in patients with cryptogenic ischemic stroke (IS) or TIA. Two recent randomized controlled clinical trials have challenged these recommendations. METHODS: We performed a systematic review and network meta-analysis of randomized controlled trials to estimate the safety and efficacy of closure compared to medical treatment, and to compare available devices. We conducted pairwise meta-analyses for closure vs medical therapy, irrespective of the device used, and for each device vs medical therapy. RESULTS: Our literature search highlighted 6 studies. PFO occlusion was associated with reduced risk of recurrent IS (risk ratio [RR] 0.42, 95% confidence interval [CI] 0.20-0.91) and IS/TIA (RR 0.65, 95% CI 0.48-0.88) but with increased risk of new-onset atrial fibrillation (AF) (RR 4.59, 95% CI 2.01-10.45) compared to medical treatment. In indirect analyses, both Amplatzer (AMP) and GORE devices were found to be associated with a lower risk of new-onset AF compared to STARFlex (SFX) (RR 0.25, 95% CI 0.10-0.65 and RR 0.28, 95% CI 0.08-0.95). Moreover, AMP was found to be associated with a lower risk of recurrent IS/TIA events compared to the SFX device (RR 0.35, 95% CI 0.14-0.91). In the clustered ranking plot on the risk of IS against new-onset AF, GORE was comparable to AMP; however, on the risk of IS/TIA against new-onset AF, AMP appeared to be superior to the GORE device. In both ranking plots, SFX was highlighted as the worst option. CONCLUSION: PFO closure is associated with reduced risk of recurrent IS or IS/TIA and with increased risk of new-onset AF.
OBJECTIVE: Current guidelines report no benefit for patent foramen ovale (PFO) closure compared to medical treatment in patients with cryptogenic ischemic stroke (IS) or TIA. Two recent randomized controlled clinical trials have challenged these recommendations. METHODS: We performed a systematic review and network meta-analysis of randomized controlled trials to estimate the safety and efficacy of closure compared to medical treatment, and to compare available devices. We conducted pairwise meta-analyses for closure vs medical therapy, irrespective of the device used, and for each device vs medical therapy. RESULTS: Our literature search highlighted 6 studies. PFO occlusion was associated with reduced risk of recurrent IS (risk ratio [RR] 0.42, 95% confidence interval [CI] 0.20-0.91) and IS/TIA (RR 0.65, 95% CI 0.48-0.88) but with increased risk of new-onset atrial fibrillation (AF) (RR 4.59, 95% CI 2.01-10.45) compared to medical treatment. In indirect analyses, both Amplatzer (AMP) and GORE devices were found to be associated with a lower risk of new-onset AF compared to STARFlex (SFX) (RR 0.25, 95% CI 0.10-0.65 and RR 0.28, 95% CI 0.08-0.95). Moreover, AMP was found to be associated with a lower risk of recurrent IS/TIA events compared to the SFX device (RR 0.35, 95% CI 0.14-0.91). In the clustered ranking plot on the risk of IS against new-onset AF, GORE was comparable to AMP; however, on the risk of IS/TIA against new-onset AF, AMP appeared to be superior to the GORE device. In both ranking plots, SFX was highlighted as the worst option. CONCLUSION: PFO closure is associated with reduced risk of recurrent IS or IS/TIA and with increased risk of new-onset AF.