Key result
Early antiplatelet discontinuation after PFO closure is associated with similar NACE risk versus continuation.
Why the study?
The optimal duration of antiplatelet therapy after patent foramen ovale device closure remains uncertain.
Does early discontinuation of antiplatelet therapy (≤12 months) reduce net adverse clinical events compared to continuation (>12 months) in patients after successful PFO closure?
Cohort (n=940)
Yes
Does early discontinuation of antiplatelet therapy (≤12 months) reduce net adverse clinical events compared to continuation (>12 months) in patients after successful PFO closure?
Early discontinuation of antiplatelet therapy (≤12 months) after successful PFO closure is associated with lower major bleeding and, in patients with a RoPE score ≥7, a lower incidence of NACE at long-term follow-up.
Short-term APT may reduce net events in high-RoPE patients post-PFO closure; leaves open optimal duration pending prospective trials.
BACKGROUND: The optimal duration of antiplatelet therapy (APT) after patent foramen ovale (PFO) device closure remains uncertain. OBJECTIVES: This study aimed to evaluate the impact of APT duration on long-term outcomes after PFO closure. METHODS: PROLONG (PFO Transcatheter Occlusion Long-Term Outcomes National Group; NCT06504121) is a multicenter retrospective registry of patients who underwent PFO device closure between 1999 and 2013 at 12 Italian centers. This analysis included patients with successful PFO closure, no significant residual shunt, and no other indication for long-term antithrombotic therapy. Patients were categorized by APT duration after PFO closure in the discontinuation group (≤12 months) or the continuation group (>12 months). The primary outcome was net adverse clinical events (NACE), a composite of ischemic events (ischemic stroke, transient ischemic attack, or systemic embolism) and major bleeding (Bleeding Academic Research Consortium ≥3). Inverse probability of treatment weighting was applied for baseline confounders. RESULTS: Among 940 patients (mean age 47 ± 12 years; 55% women) followed for 14.0 ± 3.1 years, the cumulative incidence of NACE was 3.6% in the APT discontinuation group and 7.2% in the APT continuation group (adjusted HR [aHR]: 0.71; 95% CI: 0.38-1.37; P = 0.31). Ischemic events were similar (3.1% vs 4.3%; P = 0.66), while major bleeding was lower in the APT discontinuation group (0.9% vs 2.8%; P = 0.014). APT discontinuation was associated with lower NACE in patients with Risk of Paradoxical Embolism (RoPE) score ≥7 (aHR: 0.32; 95% CI: 0.11-0.90; P = 0.039), but not in those with RoPE <7 (aHR: 1.07; 95% CI: 0.49-2.35; P = 0.89; P for interaction = 0.089). CONCLUSIONS: In patients with a RoPE score ≥7, early discontinuation of APT after effective PFO closure was associated with a lower incidence of NACE at long-term follow-up.
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Gaspardone et al. (2026) conducted a cohort in Patent foramen ovale (PFO) after device closure (n=940). Antiplatelet therapy discontinuation (≤12 months) vs. Antiplatelet therapy continuation (>12 months) was evaluated on Net adverse clinical events (NACE), a composite of ischemic events (ischemic stroke, transient ischemic attack, or systemic embolism) and major bleeding (aHR 0.71, 95% CI 0.38-1.37, p=0.31). Early discontinuation of antiplatelet therapy (≤12 months) after PFO closure resulted in a NACE rate of 3.6% vs 7.2% for continuation (aHR 0.71; 95% CI 0.38-1.37; P=0.31).
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