Tailoring Antiplatelet Therapy Duration 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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Journal
JACC Advances
Published
2026-06-30
DOI
https://doi.org/10.1016/j.jacadv.2026.102943
Primary Topic
Coronary Interventions and Diagnostics
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article
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article

Tailoring Antiplatelet Therapy Duration After PFO Closure

Andrea Donti, Alessandro Beneduce, Marco Ancona, Roberto Nerla et al.
JACC Advances
Coronary Interventions and Diagnostics
article

Tailoring Antiplatelet Therapy Duration After PFO Closure

Andrea Donti, Alessandro Beneduce, Marco Ancona, Roberto Nerla, Achille Gaspardone, Matteo Montorfano, Giorgio Bassanelli, Carlo Pappone, Riccardo Mager, Giuseppe Patti, Massimo Slavich, Giulio Falasconi, Carlo Gaspardone, Filippo Scalise, Gianluca Ricchetti, Michele Morosato, Francesco Versaci, Chiara Fraccaro, Carmine Musto, Francesco Saia, Riccardo Mazza, Gabriele Paci, Francesco Burzotta, Paolo Costa, Evelina Toscano, Luca A. Ferri, B Bellini, Cosmo Godino, Fausto Castriota, Giuseppe Barone, Alaide Chieffo, Giuseppe Tarantini, Filippo Russo, Daniela Trabattoni, Massimo Mancone, Maurizio Paciaroni, Ciro S. Vella, Francesca Napoli, Marco Metra, Daniele O. d’Atri
article en

Abstract

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.

JACC AdvancesVol. 5(8)
University of Padua (IT), Vita-Salute San Raffaele University (IT), University of Ferrara (IT), Policlinico Umberto I (IT), Agostino Gemelli University Polyclinic (IT), San Raffaele University of Rome (IT), Centro Cardiologico Monzino (IT), Departament de Salut (ES), IRCCS Azienda Ospedliero-Universitaria di Bologna Policlinico di Sant'Orsola (IT), Maria Cecilia Hospital (IT), Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia (IT), IRCCS San Camillo Hospital (IT), Ospedale Santa Maria Goretti (IT), St. Eugenio Hospital (IT), Istituti di Ricovero e Cura a Carattere Scientifico (IT), Istituto di Ricovero e Cura a Carattere Scientifico San Raffaele (IT), Universitat de Barcelona (ES), University of Brescia (IT), Sapienza University of Rome (IT)
Openalex Percentile: Top 6%
Coronary Interventions and Diagnostics
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