Comparison of long-term and short-term antiplatelet therapy after endovascular closure of patent foramen ovale: a meta-analysis of clinical trial data

Background. Administration of antiplatelet therapy (APT) is the basis for the prevention of thrombotic complications after endovascular closure of patent foramen ovale (PFO). The 2018 European consensus document on the management of patients with PFO recommended long-term APT. Dual antiplatelet therapy was prescribed for 6 months followed by acetylsalicylic acid (ASC) monotherapy for up to 5 years. Subsequent clinical trials demonstrated a trend towards shorter APT due to the risk of ASC-associated bleeding. In 2022, the SCAI society recommended limiting the duration of APT to 5 months. However, the evidence base is insufficient. Aim. To compare the efficacy and safety of shortened and prolonged APT regimens after endovascular closure of PFO. Materials and methods. Data were searched for the period from January 2017 to May 2024. The primary endpoint was defined as the development of recurrent ischemic stroke (IS). The development of major bleeding was selected as the secondary endpoint. The combined endpoint (CEP) included all-cause death, IS, transient ischemic attack, peripheral thrombosis, myocardial infarction, and major bleeding. Results. Eighty-nine sources were analyzed, of which 3 studies with a total sample of 1870 patients were included in the meta-analysis, which included 731 and 1139 patients with shortened and prolonged APT, respectively. Fatal outcome was recorded in 7 patients receiving abbreviated APT and 6 patients receiving prolonged APT. Patients in both groups had a comparable risk of mortality (RR 1.97; 95% CI 0.59–6.57; p=0.24; I2=29%). Similar results were obtained for the risk of TIA (RR 1.02; 95% CI 0.43 to 2.42; p=0.41; I2=0%), for the risk of IS (RR 1.01; 95% CI 0.41–2.49; p=0.59; I2=0%), and for minor bleeding (RR 0.81; 95% CI 0.49–1.34; p=0.24; I2=29%). CEP was achieved in 26 patients receiving abbreviated APT and 39 patients receiving prolonged APT; the risk of CEP did not significantly differ between combined endpoints (RR 1.04; 95% CI 0.63–1.72; p=0.15; I2=48%). Discussion. The results of the meta-analysis showed that there was no statistical difference between abbreviated and prolonged APT in terms of efficacy and safety, which is consistent with previous clinical studies. Conclusion. Abbreviated APT can be considered as the strategy of choice in patients at high risk of bleeding and in the absence of risk factors for thromboembolism. Conducting new studies will make it possible to accurately determine the duration of APT and develop clinical recommendations with a convincing evidence base.

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Journal
Terapevticheskii arkhiv
Published
2024-12-27
DOI
https://doi.org/10.26442/00403660.2024.12.203004
Primary Topic
Cardiovascular and Diving-Related Complications
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article
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article

Comparison of long-term and short-term antiplatelet therapy after endovascular closure of patent foramen ovale: a meta-analysis of clinical trial data

А. С. Терещенко, Makka R. Azimova, A. V. Strelkova, А. Л. Комаров et al.
Terapevticheskii arkhiv
Cardiovascular and Diving-Related Complications
article

Comparison of long-term and short-term antiplatelet therapy after endovascular closure of patent foramen ovale: a meta-analysis of clinical trial data

А. С. Терещенко, Makka R. Azimova, A. V. Strelkova, А. Л. Комаров, Е. В. Меркулов, M. G. Chashchin, Nikita S. Grishin
article en

Abstract

Background. Administration of antiplatelet therapy (APT) is the basis for the prevention of thrombotic complications after endovascular closure of patent foramen ovale (PFO). The 2018 European consensus document on the management of patients with PFO recommended long-term APT. Dual antiplatelet therapy was prescribed for 6 months followed by acetylsalicylic acid (ASC) monotherapy for up to 5 years. Subsequent clinical trials demonstrated a trend towards shorter APT due to the risk of ASC-associated bleeding. In 2022, the SCAI society recommended limiting the duration of APT to 5 months. However, the evidence base is insufficient. Aim. To compare the efficacy and safety of shortened and prolonged APT regimens after endovascular closure of PFO. Materials and methods. Data were searched for the period from January 2017 to May 2024. The primary endpoint was defined as the development of recurrent ischemic stroke (IS). The development of major bleeding was selected as the secondary endpoint. The combined endpoint (CEP) included all-cause death, IS, transient ischemic attack, peripheral thrombosis, myocardial infarction, and major bleeding. Results. Eighty-nine sources were analyzed, of which 3 studies with a total sample of 1870 patients were included in the meta-analysis, which included 731 and 1139 patients with shortened and prolonged APT, respectively. Fatal outcome was recorded in 7 patients receiving abbreviated APT and 6 patients receiving prolonged APT. Patients in both groups had a comparable risk of mortality (RR 1.97; 95% CI 0.59–6.57; p=0.24; I2=29%). Similar results were obtained for the risk of TIA (RR 1.02; 95% CI 0.43 to 2.42; p=0.41; I2=0%), for the risk of IS (RR 1.01; 95% CI 0.41–2.49; p=0.59; I2=0%), and for minor bleeding (RR 0.81; 95% CI 0.49–1.34; p=0.24; I2=29%). CEP was achieved in 26 patients receiving abbreviated APT and 39 patients receiving prolonged APT; the risk of CEP did not significantly differ between combined endpoints (RR 1.04; 95% CI 0.63–1.72; p=0.15; I2=48%). Discussion. The results of the meta-analysis showed that there was no statistical difference between abbreviated and prolonged APT in terms of efficacy and safety, which is consistent with previous clinical studies. Conclusion. Abbreviated APT can be considered as the strategy of choice in patients at high risk of bleeding and in the absence of risk factors for thromboembolism. Conducting new studies will make it possible to accurately determine the duration of APT and develop clinical recommendations with a convincing evidence base.

Terapevticheskii arkhivVol. 96(12)
National Research Center for Preventive Medicine (RU), National Medical Research Center of Cardiology (RU)
Openalex Percentile: Top 55%
Cardiovascular and Diving-Related Complications
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