Despite the absence of significant association with the primary composite outcome in unadjusted analysis, benefit became marginally significant after covariate adjustment.
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A Narrative and Critical Review of Randomized-Controlled Clinical Trials on Patent Foramen Ovale Closure for Reducing the Risk of Stroke Recurrence.
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The sentences
In contrast, the effect of PFO closure was highly significant among patients with moderate-to-large shunt size.
More importantly, PFO closure was associated with a significant reduction of the risk of stroke recurrence in both unadjusted and adjusted analyses, whereas when only the 2 trials that used disc occluder devices were included, recurrent stroke risk reduction proved clearly significant and more pronounced.
Rates of AF were numerically increased with device closure in the overall analysis but did not reach statistical significance.