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Comparison of antithrombotic strategies in patients with cryptogenic stroke and patent foramen ovale: an updated meta-analysis

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Abstract

Purpose

Patients with patent foramen ovale (PFO) and cryptogenic ischemic stroke (CS) are at risk for stroke recurrence. The optimal antithrombotic strategy in patients who undergo medical management is still debated.

Methods

We systematically searched the literature for studies that reported on cerebrovascular event recurrences and/or death in patients with PFO treated with oral anticoagulation (OAC) or antiplatelet therapy (APT) for secondary prevention of CS. The efficacy endpoints were stroke recurrence and the composite of stroke, transient ischemic attack or all-cause death. Major bleedings represented the safety endpoint.

Results

A total of 16 studies with 3953 patients (OAC = 1527, APT = 2426) were included. Weighted mean follow-up was 2.9 years. OAC was associated with a significant reduction in the risk of stroke compared with APT (RR 0.65; 95% CI 0.44–0.95; ARR 2%, NNT 49), while no difference was found regarding the composite outcome (RR 0.78; 95% CI 0.57–1.07) and the safety outcome (RR 1.57; 95% CI 0.85–2.90; p = 0.15).

Conclusions

OAC was more effective than APT in reducing the risk of stroke recurrence in patients with PFO and CS, without a significant increase in the risk of major bleedings. Our findings support the need for further randomized data focused on the comparison of antithrombotic strategies in this setting.

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Availability of data and material

The data supporting the findings of this study are available from the corresponding author on reasonable request.

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Funding

This study required no funding.

Author information

Authors and Affiliations

  1. Division of Cardiology, Department of Medical Sciences, University of Turin, Città della Salute e della Scienza Hospital, Torino, Italy

    Filippo Angelini, Pier Paolo Bocchino, Luca Franchin, Ovidio De Filippo, Matteo Bellettini, Fabrizio D’Ascenzo & Gaetano M. De Ferrari

  2. Division of Cardiology, University of Pavia, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy

    Federico Fortuni, Gabriele Crimi & Sergio Leonardi

  3. Second Department of Neurology, School of Medicine, “Attikon” University Hospital, National & Kapodistrian University of Athens, Athens, Greece

    Georgios Tsivgoulis

  4. Department of Neurology, University of Tennessee Health Sciences Center, Memphis, TN, USA

    Georgios Tsivgoulis

  5. Stroke Unit and Division of Cardiovascular Medicine, University of Perugia, S. Maria della Misericordia Hospital, Perugia, Italy

    Giancarlo Agnelli & Maurizio Paciaroni

  6. Coronary Care Unit and Laboratory of Clinical and Experimental Cardiology, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy

    Sergio Leonardi

Authors
  1. Filippo Angelini
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  2. Federico Fortuni
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  3. Georgios Tsivgoulis
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  13. Maurizio Paciaroni
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Contributions

FA and MP contributed to the study conception and design. Literature search, data extraction, and analyses were performed by FA, FF, and MB. The first draft of the manuscript was written by FA and FF; all authors critically revised the work. All authors read and approved the final manuscript.

Corresponding author

Correspondence to Filippo Angelini.

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Conflict of interest

Giancarlo Agnelli received honoraria as a member of the speaker bureau of Boehringer Ingelheim and Bayer. Maurizio Paciaroni received honoraria as a member of the speaker bureau of Sanofi-Aventis, Boehringer Ingelheim, Bayer, Bristol Meyer Squibb, and Pfizer. The other authors have nothing to disclose.

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Angelini, F., Fortuni, F., Tsivgoulis, G. et al. Comparison of antithrombotic strategies in patients with cryptogenic stroke and patent foramen ovale: an updated meta-analysis. Cardiovasc Drugs Ther 35, 987–993 (2021). https://doi.org/10.1007/s10557-020-07068-9

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