Why the study?
The optimal treatment strategy for patent foramen ovale patients with cryptic stroke remains controversial.
Does patent foramen ovale closure reduce the composite outcome of recurrent stroke and/or transient ischemic attack in patients with patent foramen ovale and cryptic stroke compared to medical therapy?
Does patent foramen ovale closure reduce the composite outcome of recurrent stroke and/or transient ischemic attack in patients with patent foramen ovale and cryptic stroke compared to medical therapy?
PFO closure reduces recurrent ischemic events compared to antiplatelet therapy but not compared to anticoagulant therapy, while increasing the risk of atrial fibrillation.
PFO closure decisions in cryptogenic stroke warrant individualized caution; Level 3 observational meta-analysis leaves comparative efficacy open.
BACKGROUND: The optimal treatment strategy for patent foramen ovale (PFO) patients with cryptic stroke remains controversial. We performed this meta-analysis to evaluate the effect of PFO closure versus different types of medical therapy. METHODS: We searched PubMed, Embase, and Cochrane databases. The primary efficacy endpoints were the composite outcome of recurrent stroke and/or transient ischemic attack (TIA). Secondary efficacy endpoints included separate stroke and TIA. Safety endpoints included new-onset atrial fibrillation (AF)/atrial flutter and bleeding. RESULTS: Compared with antiplatelet therapy, PFO closure significantly reduced the risk of composite outcome (odds ratio [OR] 0.37, 95% confidence interval [CI] 0.27-0.51), stroke (OR 0.22, 95% CI 0.13-0.36], and TIA (OR 0.57, 95% CI 0.34-0.98); Compared with the mixed medical therapy group (consist of antiplatelet therapy, anticoagulant therapy, or both), PFO closure still showed some benefits, but the effect was not as significant as that of antiplatelet therapy (composite outcome: OR 0.53, 95% CI 0.41-0.69; stroke: OR 0.48, 95% CI 0.34-0.68; TIA: OR 0.69, 95% CI 0.50-0.96); Compared with anticoagulant therapy, PFO closure showed no benefit (composite outcome: OR 0.77, 95% CI 0.46-1.28; stroke: OR 0.59, 95% CI 0.28-1.25; TIA: OR 1.01, 95% CI 0.50-2.04). In terms of safe endpoints, compared with antiplatelet therapy and anticoagulant therapy, PFO closure increased the risk of AF/atrial flutter (OR 9.56, 95% CI 2.85-32.06; OR 18.96, 95% CI 1.11-323.8, respectively) and reduced the risk of bleeding (OR 0.50, 95% CI 0.24-1.05; OR 0.13, 95% CI 0.04-0.46, respectively); compared with mixed medical therapy, PFO closure increased the risk of AF/atrial flutter (OR 4.40,95% CI 2.24-8.67), but there was no difference in bleeding (OR 0.97, 95% CI 0.56-1.68). CONCLUSIONS: With the addition of anticoagulants, the benefit of PFO closure decreased gradually. Patient groups that adopt individualized medical therapy strategies may benefit more.
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Pan et al. (2021) studied this question.
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