Percutaneous patent foramen ovale closure for secondary stroke prevention

Network meta-analysis

Georgios Tsivgoulis, Aristeidis H. Katsanos, Dimitris Mavridis, Alexandra Frogoudaki, Agathi Rosa Vrettou, Ignatios Ikonomidis, John Parissis, Spyridon Deftereos, Theodore Karapanayiotides, Lina Palaiodimou, Angeliki Filippatou, Fabienne Perren, Georgios Hadjigeorgiou, Anne W. Alexandrov, Panayiotis D. Mitsias, Andrei V. Alexandrov

Research output: Contribution to journalArticle

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.

Original languageEnglish (US)
Pages (from-to)e8-e18
JournalNeurology
Volume91
Issue number1
DOIs
StatePublished - Jul 3 2018

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Septal Occluder Device
Patent Foramen Ovale
Thrombolytic Therapy
Secondary Prevention
Stroke
Atrial Fibrillation
Odds Ratio
Confidence Intervals
Equipment and Supplies
Randomized Controlled Trials
Therapeutics
Network Meta-Analysis
Meta-Analysis
Guidelines
Safety

All Science Journal Classification (ASJC) codes

  • Clinical Neurology

Cite this

Tsivgoulis, G., Katsanos, A. H., Mavridis, D., Frogoudaki, A., Vrettou, A. R., Ikonomidis, I., ... Alexandrov, A. V. (2018). Percutaneous patent foramen ovale closure for secondary stroke prevention: Network meta-analysis. Neurology, 91(1), e8-e18. https://doi.org/10.1212/WNL.0000000000005739

Percutaneous patent foramen ovale closure for secondary stroke prevention : Network meta-analysis. / Tsivgoulis, Georgios; Katsanos, Aristeidis H.; Mavridis, Dimitris; Frogoudaki, Alexandra; Vrettou, Agathi Rosa; Ikonomidis, Ignatios; Parissis, John; Deftereos, Spyridon; Karapanayiotides, Theodore; Palaiodimou, Lina; Filippatou, Angeliki; Perren, Fabienne; Hadjigeorgiou, Georgios; Alexandrov, Anne W.; Mitsias, Panayiotis D.; Alexandrov, Andrei V.

In: Neurology, Vol. 91, No. 1, 03.07.2018, p. e8-e18.

Research output: Contribution to journalArticle

Tsivgoulis, G, Katsanos, AH, Mavridis, D, Frogoudaki, A, Vrettou, AR, Ikonomidis, I, Parissis, J, Deftereos, S, Karapanayiotides, T, Palaiodimou, L, Filippatou, A, Perren, F, Hadjigeorgiou, G, Alexandrov, AW, Mitsias, PD & Alexandrov, AV 2018, 'Percutaneous patent foramen ovale closure for secondary stroke prevention: Network meta-analysis', Neurology, vol. 91, no. 1, pp. e8-e18. https://doi.org/10.1212/WNL.0000000000005739
Tsivgoulis, Georgios ; Katsanos, Aristeidis H. ; Mavridis, Dimitris ; Frogoudaki, Alexandra ; Vrettou, Agathi Rosa ; Ikonomidis, Ignatios ; Parissis, John ; Deftereos, Spyridon ; Karapanayiotides, Theodore ; Palaiodimou, Lina ; Filippatou, Angeliki ; Perren, Fabienne ; Hadjigeorgiou, Georgios ; Alexandrov, Anne W. ; Mitsias, Panayiotis D. ; Alexandrov, Andrei V. / Percutaneous patent foramen ovale closure for secondary stroke prevention : Network meta-analysis. In: Neurology. 2018 ; Vol. 91, No. 1. pp. e8-e18.
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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.",
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T2 - Network meta-analysis

AU - Tsivgoulis, Georgios

AU - Katsanos, Aristeidis H.

AU - Mavridis, Dimitris

AU - Frogoudaki, Alexandra

AU - Vrettou, Agathi Rosa

AU - Ikonomidis, Ignatios

AU - Parissis, John

AU - Deftereos, Spyridon

AU - Karapanayiotides, Theodore

AU - Palaiodimou, Lina

AU - Filippatou, Angeliki

AU - Perren, Fabienne

AU - Hadjigeorgiou, Georgios

AU - Alexandrov, Anne W.

AU - Mitsias, Panayiotis D.

AU - Alexandrov, Andrei V.

PY - 2018/7/3

Y1 - 2018/7/3

N2 - 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.

AB - 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.

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