Optimizing antithrombotic therapy after PFO closure: insights from real-world practice
A Papanikolaou, A Apostolos, G Tsigkas, K ToutouzasAbstract
Background
The safety and efficacy of transcatheter patent foramen ovale (PFO) closure for secondary prevention in patients with cryptogenic stroke have been demonstrated in multiple randomized controlled trials. The recently published European guidelines recommend a 21-day course of dual antiplatelet therapy (DAPT) following an ischemic stroke, followed by tailored therapy with aspirin or clopidogrel, and DAPT for 3–6 months after PFO closure, followed by individualized antiplatelet therapy. However, the extent to which these recommendations are implemented in contemporary practice remains unclear, and data regarding discontinuation of antithrombotic therapy are limited.
Aim
This study aimed to investigate prevailing trends in the duration and customization of antithrombotic therapy before and after transcatheter PFO closure, and to assess the safety of antiplatelet therapy discontinuation months after the procedure.
Methods
We retrospectively analyzed 135 patients who underwent percutaneous PFO closure for secondary stroke prevention at a tertiary center between July 2017 and September 2024. Complete data were available for 102 patients. Baseline demographics, comorbidities, and pharmacological treatments were collected from electronic medical records. The primary endpoint was recurrent ischemic cerebrovascular events. Secondary endpoints included bleeding complications and the occurrence of atrial fibrillation (AF) or other arrhythmias.
Results
The mean age of patients was 45.5 years, and 56.6% were male. Common comorbidities included dyslipidemia (50%), hypertension (30.2%), and diabetes mellitus (10%), while AF and coronary artery disease were present only in one patient. Before the procedure, 72% of patients received single and 28% received dual antiplatelet therapy. The Amplatzer™ Talisman™ PFO Occluder was used in 52% and GORE® CARDIOFORM in 48% of the patients, with sizes ranging from 12 to 35 mm. After the PFO Closure, 99 patients received antiplatelet therapy, with 92% receiving DAPT for a mean duration of 3 months, followed by monotherapy in 61% of cases. Only 5 patients received NOACs. Over a mean follow-up of 913 days, two patients experienced cerebrovascular events (one ischemic stroke and one TIA), and nine patients developed new-onset paroxysmal AF, primarily within the first three months after the procedure. No major bleeding events were observed, and minor bleeding occurred in 4.9% of patients.
Conclusions
Percutaneous PFO closure is safe in real-world clinical practice. Low rates of recurrent cerebrovascular events, arrhythmias, and bleeding complications are reported under antithrombotic agents and gradual discontinuation of antiplatelet therapy was feasible in most patients without adverse outcomes. These findings provide important insights into contemporary antithrombotic management following PFO closure.