Still No Closure on the Question of PFO Closure
Available from: Vasileios Papavasileiou
- "A possible reason for this result may be the lack of a significant treatment effect of PFO closure . However, it should be noticed that the rate of outcome events in these trials was lower than the expected, rendering the trials relatively underpowered   . "
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ABSTRACT: This study aims to assess whether patent foramen ovale (PFO) closure is superior to medical therapy in preventing recurrence of cryptogenic ischemic stroke or transient ischemic attack (TIA).
We searched PubMed for randomized trials which compared PFO closure with medical therapy in cryptogenic stroke/TIA using the items: "stroke or cerebrovascular accident or TIA" and "patent foramen ovale or paradoxical embolism" and "trial or study".
Among 650 potentially eligible articles, 3 were included including 2303 patients. There was no statistically significant difference between PFO-closure and medical therapy in ischemic stroke recurrence (1.91% vs. 2.94% respectively, OR: 0.64, 95%CI: 0.37-1.10), TIA (2.08% vs. 2.42% respectively, OR: 0.87, 95%CI: 0.50-1.51) and death (0.60% vs. 0.86% respectively, OR: 0.71, 95%CI: 0.28-1.82). In subgroup analysis, there was significant reduction of ischemic strokes in the AMPLATZER PFO Occluder arm vs. medical therapy (1.4% vs. 3.04% respectively, OR: 0.46, 95%CI: 0.21-0.98, relative-risk-reduction: 53.2%, absolute-risk-reduction: 1.6%, number-needed-to-treat: 61.8) but not in the STARFlex device (2.7% vs. 2.8% with medical therapy, OR: 0.93, 95%CI: 0.45-2.11). Compared to medical therapy, the number of patients with new-onset atrial fibrillation (AF) was similar in the AMPLATZER PFO Occluder arm (0.72% vs. 1.28% respectively, OR: 1.81, 95%CI: 0.60-5.42) but higher in the STARFlex device (0.64% vs. 5.14% respectively, OR: 8.30, 95%CI: 2.47-27.84).
This meta-analysis does not support PFO closure for secondary prevention with unselected devices in cryptogenic stroke/TIA. In subgroup analysis, selected closure devices may be superior to medical therapy without increasing the risk of new-onset AF, however. This observation should be confirmed in further trials using inclusion criteria for patients with high likelihood of PFO-related stroke recurrence.
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ABSTRACT: Stroke without a known cause, or cryptogenic stroke, accounts for up to 30 % of all ischemic strokes. Paradoxical embolism through a patent foramen ovale (PFO) has been implicated as a potential cause of cryptogenic cerebral ischemia, particularly in young patients. Epidemiological studies have noted an association between PFO and cryptogenic stroke and observational studies have suggested the potential superiority of percutaneous PFO closure over medical therapy. However, until recently, there were no randomized data to test the hypothesis that PFO closure reduces the risk of recurrent cerebral ischemia. The publication of three such trials, all failing to demonstrate a therapeutic advantage for closure over medical therapy in intention-to-treat analyses, provides valuable new data in the field. We review epidemiological evidence linking PFO and stroke and recent observational and randomized trial data evaluating different treatment strategies.
Available from: David E Thaler
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