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Publications

Journal Article Ahead of print

PubMed: 42379134 DOI: 10.1016/j.jacadv.2026.102943

Tailoring Antiplatelet Therapy Duration After PFO Closure: Insights From the PROLONG Registry.

JACC Adv 5(8):102943

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

Affiliations

  • Interventional Cardiology Unit, IRCCS San Raffaele Scientific Institute, Milan, Italy; Department of General Surgery and Surgical Specialty Paride Stefanini, Sapienza University of Rome.
  • IRCCS Centro Cardiologico Monzino, Milan, Italy.
  • Vita-Salute San Raffaele University, IRCCS San Raffaele Scientific Institute, Milan, Italy.
  • Department of Cardiac, Thoracic, Vascular Science and Public Health, University of Padova, Italy.
  • Cardiac Surgery Unit, IRCCS San Raffaele Scientific Institute, Milan, Italy.
  • Institute of Cardiology, ASST Spedali Civili, University of Brescia, Brescia, Italy.
  • ⁠Facultat de Medicina i Ciències de la Salut, Universitat de Barcelona (UB), Barcelona, Spain.
  • IRCCS University Hospital of Bologna, Policlinico S. Orsola, Bologna, Italy.
  • Department of Interventional Cardiology, Policlinico di Monza, Monza, Italy.
  • Division of Cardiology, Maggiore della Carità Hospital, Novara, Italy.
  • Cardiology Unit, Maria Cecilia Hospital GVM Care and Research, Cotignola, Italy.
  • Division of Cardiology, San Camillo Hospital, Rome, Italy.
  • Department of Neurosciences and Rehabilitation, University of Ferrara, Ferrara, Italy.
  • Department of Cardiovascular Sciences, IRCCS A. Gemelli University Polyclinic, Rome, Italy.
  • Interventional Cardiology Unit, IRCCS San Raffaele Scientific Institute, Milan, Italy.
  • Division of Cardiology, Santa Maria Goretti Hospital, Latina, Italy.
  • Vita-Salute San Raffaele University, IRCCS San Raffaele Scientific Institute, Milan, Italy; Department of Arrhythmology, IRCCS San Donato, Milan, Italy.
  • Department of General Surgery and Surgical Specialty Paride Stefanini, Sapienza University of Rome; Umberto I Hospital, Sapienza University of Rome, Rome, Italy.
  • Interventional Cardiology Unit, IRCCS San Raffaele Scientific Institute, Milan, Italy; Vita-Salute San Raffaele University, IRCCS San Raffaele Scientific Institute, Milan, Italy.
  • Division of Cardiology, S. Eugenio Hospital, Rome, Italy.
  • Interventional Cardiology Unit, IRCCS San Raffaele Scientific Institute, Milan, Italy.

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.

MeSH

Registries, Hemorrhage, Foramen Ovale, Patent, Incidence, Duration Of Therapy, Therapeutics