Patent foramen ovale closure reduced the risk of recurrent ischemic stroke (RR 0.42; 95% CI 0.20-0.91) but increased the risk of new-onset atrial fibrillation compared to medical treatment.
Meta-Analysis
Does percutaneous PFO closure reduce recurrent ischemic stroke or TIA in patients with cryptogenic stroke compared to medical treatment?
PFO closure reduces the risk of recurrent ischemic stroke or TIA in patients with cryptogenic stroke compared to medical therapy, though it increases the risk of new-onset atrial fibrillation.
Relative Risk: 0.42 (95% CI 0.2–0.91)
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.
Tsivgoulis et al. (Wed,) conducted a meta-analysis in Cryptogenic ischemic stroke or TIA. Patent foramen ovale (PFO) closure vs. Medical treatment was evaluated on Recurrent ischemic stroke (RR 0.42, 95% CI 0.20-0.91). Patent foramen ovale closure reduced the risk of recurrent ischemic stroke (RR 0.42; 95% CI 0.20-0.91) but increased the risk of new-onset atrial fibrillation compared to medical treatment.