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Updated: Jul 2, 2026
Closure of a Patent Foramen Ovale (PFO): An Intervention Sequence
Published on: December 23, 2022
Tailoring Antiplatelet Therapy Duration After PFO Closure: Insights From the PROLONG Registry
Carlo Gaspardone1, Daniela Trabattoni2, Daniele O d'Atri3
1Interventional Cardiology Unit, IRCCS San Raffaele Scientific Institute, Milan, Italy; Department of General Surgery and Surgical Specialty Paride Stefanini, Sapienza University of Rome.
Insights
Early discontinuation of antiplatelet therapy (APT) after patent foramen ovale (PFO) closure may reduce long-term risks, especially for patients with a high Risk of Paradoxical Embolism (RoPE) score.
Area of Science:
- Cardiology
- Interventional Cardiology
- Clinical Trials
Background:
- The optimal duration of antiplatelet therapy (APT) following patent foramen ovale (PFO) device closure is not well-established.
- Uncertainty exists regarding the long-term benefits and risks of extended APT post-PFO closure.
Purpose of the Study:
- To evaluate the impact of varying antiplatelet therapy durations on long-term clinical outcomes after PFO device closure.
- To identify patient subgroups who may benefit from shorter or longer durations of APT.
Main Methods:
- A multicenter retrospective registry (PROLONG study) included patients with successful PFO closure.
- Patients were stratified by APT duration: discontinuation (≤12 months) vs. continuation (>12 months).
- The primary endpoint was net adverse clinical events (NACE), including ischemic events and major bleeding, analyzed using inverse probability of treatment weighting.
Main Results:
- Among 940 patients followed for 14 years, NACE occurred in 3.6% of the discontinuation group and 7.2% of the continuation group (aHR: 0.71).
- Major bleeding was significantly lower in the discontinuation group (0.9% vs. 2.8%, P=0.014).
- APT discontinuation was linked to lower NACE in patients with a Risk of Paradoxical Embolism (RoPE) score ≥7 (aHR: 0.32).
Conclusions:
- Early APT discontinuation after PFO closure is associated with reduced long-term NACE in patients with a RoPE score ≥7.
- These findings suggest a tailored approach to APT duration based on individual patient risk profiles after PFO closure.
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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