Dataset Information

Meta-analysis of patent foramen ovale closure versus medical therapy for prevention of recurrent ischemic neurological events: Impact of medication type.

ABSTRACT:

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.

SUBMITTER: Pan X

PROVIDER: S-EPMC8238362 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:ImportancePerioperative stroke is a major complication for patients undergoing surgery. Patent foramen ovale (PFO) represents a possible anatomical link between venous thrombosis and stroke.ObjectiveTo determine whether a preoperatively diagnosed PFO is associated with increased risk of perioperative ischemic stroke.Design, setting, and participantsRetrospective cohort study from Massachusetts General Hospital and 2 affiliated community hospitals between January 1, 2007, and December 31, 2015. Participants were 182 393 consecutive adults undergoing noncardiac surgery with general anesthesia.ExposuresPreoperatively diagnosed PFO.Main outcomes and measuresPerioperative ischemic stroke occurring within 30 days of surgery; stroke subtype by Oxfordshire Community Stroke Project classification and stroke severity by National Institute of Health Stroke Scale (NIHSS).ResultsAmong the 150 198 patient cases analyzed (median [SD] age, 55 [16] years), 1540 (1.0%) had a diagnosis of PFO before surgery. A total of 850 (0.6%) ischemic strokes occurred within 30 days of surgery (49 [3.2%] among patients with PFO and 801 [0.5%] among patients without PFO). In adjusted analyses, patients with PFO had an increased risk of ischemic stroke compared with patients without PFO (odds ratio, 2.66 [95% CI, 1.96-3.63]; P < .001). The estimated risks of stroke were 5.9 for every 1000 patients with PFO and 2.2 for every 1000 patients without PFO (adjusted absolute risk difference, 0.4% [95% CI, 0.2%-0.6%). Patients with PFO also had an increased risk of large vessel territory stroke (relative risk ratio, 3.14 [95% CI, 2.21-4.48]; P < .001) and a more severe stroke-related neurologic deficit measured by NIHSS (median, 4 [interquartile range {IQR}, 2-10] vs median, 3 [IQR, 1-6] for those without PFO; P = .02).Conclusions and relevanceAmong adult patients undergoing noncardiac surgery at 3 hospitals, having a preoperatively diagnosed PFO was significantly associated with increased risk of perioperative ischemic stroke within 30 days after surgery. Further research is needed to confirm these findings and to determine whether interventions would decrease this risk.