Secondary Stroke Prevention in Patients with Patent Foramen Ovale: To Anticoagulate or Not? Fragility Index Meta-analysis of Published Randomized Controlled Studies

Abstract

Objective: The choice between the use of antiplatelet (APT) treatment and oral anticoagulant (OAC) treatment for the prevention of ischemic stroke recurrence in patients with patent foramen ovale (PFO) requires clarification.

Materials and Methods: A total of 5 randomized controlled trials comparing the preventive effect of APT and OAC therapies, including the use of non-vitamin-K OACs (NOACs), on stroke recurrence in patients with PFO were extracted from a systematic literature search. A standard meta-analysis and determination of fragility indexes were conducted.

Results: The meta-analysis showed that the effectiveness of secondary stroke prophylaxis was higher, albeit remained insignificant, in patients treated with OAC (n = 828) than in patients treated with APT (n = 889; relative risk ratio: 0.76, 95% confidence interval: 0.49–1.19); the difference was not statistically significant, and the publication bias level was acceptable. However, the fragility index of all studies (all negative when assessed individually) was determined as zero. The fragility of the performed meta-analysis was 6 (18.2%), which was 4.6x above the observed value (3.98%) for stroke prevention.

Conclusion: Research data on the use of warfarin or NOAC versus aspirin in secondary stroke prophylaxis in patients with PFO is weak and fragile. A randomized controlled trial could solve this issue.

Ethics committee approval is not required.

Not required.

Externally and internally peer-reviewed.

Concept: E.M.A., M.A.T., Design: E.M.A., M.A.T., Data Collection or Processing: E.M.A., M.A.T., Analysis or Interpretation: E.M.A., M.A.T., Literature Search: E.M.A., M.A.T., Writing: M.A.T.

No conflict of interest was declared by the authors.

The authors declared that this study received no financial support.