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Surgical vs. drug therapy in patients with patent foramen ovale and cryptogenic stroke

Chirurgische vs. medikamentöse Therapie bei Patienten mit offenem Foramen ovale und kryptogenem Schlaganfall

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Abstract

Objective

This study aimed to investigate the effectiveness of risk scoring for predicting stroke recurrence after percutaneous patent foramen ovale (PFO) closure or medication therapy in patients with PFO and a history of cryptogenic stroke.

Methods

This study included 559 patients with PFO and cryptogenic stroke who were treated in our hospital from January 2013 to January 2018 and were followed up for 15–72 months. After calculating the risk scores for stroke recurrence, we randomly divided the patients into two groups (ratio, 1:1): Patients in one group underwent PFO closure and those in the other received drug therapy.

Results

Patients in the PFO closure group had a lower risk of recurrent stroke than those in the drug therapy group (1.1% vs. 4.2%). Moreover, serious bleeding was less frequent in the PFO closure group than in the drug therapy group (0% vs. 3.2%), although the incidence of atrial fibrillation or flutter did not significantly differ between the groups (p = 0.67). Interestingly, a subgroup analysis revealed no inter-treatment group difference in the rate of cryptogenic stroke recurrence among patients with risk scores of 0–1. By contrast, PFO closure yielded superior outcomes among patients with risk scores of ≥2.

Conclusion

Compared with drug therapy, PFO closure reduced the risk of recurrent stroke among patients with a risk score of ≥2 and reduced the incidence of serious bleeding without increasing the risk of new-onset atrial fibrillation or atrial flutter.

Zusammenfassung

Ziel der Arbeit

Ziel der vorliegenden Studie war es, die Wirksamkeit der Risikobewertung zur Vorhersage eines Schlaganfallrezidivs zum einen nach perkutanem Verschluss eines offenen Foramen ovale (PFO) oder zum anderen unter medikamentöser Therapie bei Patienten mit PFO und einem kryptogenen Schlaganfall in der Anamnese zu untersuchen.

Methoden

In die Studie wurden 559 Patienten mit PFO und kryptogenem Schlaganfall einbezogen, die zwischen Januar 2013 und Januar 2018 in der Klinik der Autoren behandelt und deren Erkrankungsverlauf 15–72 Monate lang nachuntersucht wurde. Nach Ermittlung der Risikobewertung für ein Schlaganfallrezidiv unterteilten die Autoren die Patienten randomisiert in 2 Gruppen (im Verhältnis 1:1): Die Patienten in der einen Gruppe wurden mittels PFO-Verschluss und die in der anderen Gruppe medikamentös behandelt.

Ergebnisse

Die Patienten in der Gruppe mit PFO-Verschluss wiesen ein geringeres Risiko für ein Schlaganfallrezidiv auf als die in der Gruppe mit medikamentöser Therapie (1,1 vs. 4,2 %). Außerdem trat eine schwere Blutung seltener in der Gruppe mit PFO-Verschluss auf als in der Gruppe mit medikamentöser Therapie (0 vs. 3,2 %), obwohl die Inzidenz von Vorhofflimmern oder -flattern sich nicht signifikant zwischen den Gruppen unterschied (p = 0,67). Interessant war, dass eine Subgruppenanalyse keinen Unterschied zwischen den Behandlungsgruppen bei der Rezidivrate eines Schlaganfalls für Patienten mit Risikowerten von 0–1 ergab. Dagegen zeigten sich nach PFO-Verschluss überlegene Ergebnisse für Patienten mit Risikowerten von ≥2.

Schlussfolgerung

Im Vergleich mit medikamentöser Therapie reduzierten sich nach PFO-Verschluss einerseits das Risiko eines Schlaganfallrezidivs bei Patienten mit einem Risikowert von ≥2 und andererseits auch die Inzidenz schwerer Blutungen, ohne das Risiko für ein neu auftretendes Vorhofflimmern oder Vorhofflattern zu erhöhen.

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Funding

The study was funded by Health Commission of Sichuan Province: study of the risk stratification in the patients with patent foramen ovale and paradoxical embolism.

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Authors and Affiliations

  1. Cardiac Electrophysiological Center, Mianyang Central Hospital, 621000, Mianyang, Sichuan, China

    Yunbing Liu, Yi Wu & Lu Xiong

Authors
  1. Yunbing Liu
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  2. Yi Wu
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  3. Lu Xiong
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Contributions

Study design: Yunbing Liu; performed the experiments: Yi Wu and Lu Xiong; data acquisition and data analysis/interpretation: Yunbing Liu and Yi Wu; manuscript revision/review: Yunbing Liu. All authors agree to contribute to the journal Herz.

Corresponding author

Correspondence to Yunbing Liu.

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Conflict of interest

Y. Liu,Y. Wu, and L. Xiong declare that they have no competing interests.

All procedures performed in studies involving human participants or on human tissue were in accordance with the ethical standards of the institutional and/or national research committee and with the 1975 Helsinki declaration and its later amendments or comparable ethical standards and was approved by the ethics committee of Mianyang Central Hospital. Informed consent was obtained from all individual participants included in the study.

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Liu, Y., Wu, Y. & Xiong, L. Surgical vs. drug therapy in patients with patent foramen ovale and cryptogenic stroke. Herz 46, 250–254 (2021). https://doi.org/10.1007/s00059-020-04921-3

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  • DOI: https://doi.org/10.1007/s00059-020-04921-3

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