Comparison of the efficacy and safety of prolonged and reduced antiplatelet therapy after endovascular closure of patent foramen ovale: a clinical trial

Introduction. In order to prevent thrombotic complications after endovascular closure of patent foramen ovale (PFO), dual antiplatelet therapy (DAPT) is prescribed with a switch to acetylsalicylic acid monotherapy. These drugs increase the risk of bleeding, while early withdrawal of therapy can lead to recurrent ischemic stroke (IS) and transient ischemic attack (TIA). The effective and safe duration of DAPT has not been accurately established due to the small evidence base.

Aim. To compare the efficacy and safety of long-term and shortened antiplatelet therapy (AAT) in patients undergoing endovascular closure of PFO.

Material and Methods. 239 patients who underwent endovascular closure of PFO were included in the study. Clinical and anamnestic characteristics of the sample: 140 (58.58%) women, mean age 43.00 [35.00; 52.00] years, 173 (72.38%) patients had an IS and 66 (27.62%) TIA. Patients were taking APT according to two regimens. Prolonged in duration included DAPT (clopidogrel + acetylsalicylic acid) for 6 months with a switch to acetylsalicylic acid monotherapy for up to 5 years. Shortened duration included DAPT and acetylsalicylic acid monotherapy for up to 6 months. Patients were followed up for 38.23 [22.20; 48.67] months and were divided into 2 groups. The first group included 145 (60.70%) patients with prolonged duration of DAPT and the second group included 94 (39.30%) patients who were receiving DAPT according to the shortened duration regimen.

Results. There were no differences between the groups of patients with prolonged and shortened duration of DAPT in terms of clinical and anamnestic and intraoperative characteristics, complication rate, early postoperative period and long-term follow-up. The pvalue ˃ 0.05 for all comparison parameters. The duration of follow-up for the group with prolonged DAPT duration was 38.65 [23.14; 48.43] months, 110 (75.86%) patients received clopidogrel for 6 months, acetylsalicylic acid for 60 months. During follow-up, there were 6 (4.35%) bleeding events, including 1 (0.72%) major bleeding event, 1 (0.72%) IS, and 1 (0.72%) TIA. The duration of follow-up for the group with shortened DAPT duration was 35.70 [21.43; 51.67] months (p = 0.4088). A total of 74 (78.72%) patients were received clopidogrel for 6 months (p = 0.8970), and 68 (72.34%) discontinued acetylsalicylic acid therapy 6 months after endovascular closure of the PFO. There was 1 (1.18%) minor bleeding and 1 (1.18%) IS during follow-up (p ˃ 0.05).

Conclusion. Prolonged duration and shortened to 6 months APT have comparable efficacy in preventing thrombotic complications after endovascular closure of the PFO. Administration of APT may risk of bleeding, the likelihood of which increases with the duration of treatment. The decision on the duration of APT should be made individually based on the risk of thrombosis and bleeding.

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