Key result
Stopping antiplatelets within 12 months of PFO closure linked to ~65% lower NACE in RoPE ≥7 patients.
Why the study?
The optimal duration of antiplatelet therapy following patent foramen ovale device closure remains uncertain.
Does short-term antiplatelet therapy (≤12 months) reduce net adverse clinical events compared to long-term therapy (>12 months) in patients after successful PFO closure?
Does short-term antiplatelet therapy (≤12 months) reduce net adverse clinical events compared to long-term therapy (>12 months) in patients after successful PFO closure?
Discontinuing antiplatelet therapy within 12 months after PFO closure is associated with fewer net adverse clinical events, driven by reduced major bleeding, particularly in patients with a RoPE score ≥ 7.
May support APT discontinuation at 12 months post-PFO closure in high-RoPE patients; hypothesis-generating pending randomized trials.
Background Following patent foramen ovale (PFO) device closure, the optimal duration of antiplatelet therapy (APT) remains uncertain. Objectives To evaluate the impact of APT duration on long-term outcomes after PFO closure. Methods This analysis of the PROLONG (PFO Transcatheter Occlusion Long-Term Outcomes National Group) registry included patients with successful PFO closure, no significant residual shunt, and no other indication for chronic antithrombotic therapy. Patients were categorized into short-term (≤12 months) and long-term (>12 months) APT groups. The primary outcome was net adverse clinical events (NACE), defined as a composite of ischemic events (ischemic stroke, transient ischemic attack, or systemic embolism) and major bleeding (BARC ≥ 3). Results Among 940 patients (mean age 47 ± 12 years, 55% women), NACE occurred in 3.7% of the short-term and 6.3% of the long-term APT groups over a mean follow-up of 14.0 ± 3.1 years (HR 0.61; 95% CI 0.33–1.10; p=0.101). The difference was mainly driven by fewer major bleeding events (HR 0.32; 95% CI 0.10–0.95; p=0.046). The benefit of short-term APT was evident among patients with a Risk of Paradoxical Embolism (RoPE) score ≥7 (HR 0.35; 95% CI 0.12–0.92; p=0.043), but not in those with lower scores (HR 0.86; 95% CI 0.41–1.79; p=0.683). Conclusions In patients with RoPE score ≥ 7, discontinuing antiplatelet therapy within 12 months after PFO closure was associated with fewer net adverse clinical events at long-term follow-up.
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Gaspardone et al. (2026) studied this question. Discontinuing antiplatelet therapy within 12 months after PFO closure reduced major bleeding (HR 0.32) and lowered net adverse clinical events in patients with a RoPE score ≥7 (HR 0.35).
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