Propensity Score-Based Analysis of Percutaneous Closure Versus Medical Therapy in Patients With Cryptogenic Stroke and Patent Foramen Ovale: The IPSYS Registry (Italian Project on Stroke in Young Adults).

Abstract

BACKGROUND:

We sought to compare the benefit of percutaneous closure to that of medical therapy alone for the secondary prevention of embolism in patients with patent foramen ovale (PFO) and otherwise unexplained ischemic stroke, in a propensity scored study.

METHODS AND RESULTS:

Between 2000 and 2012, we selected consecutive first-ever ischemic stroke patients aged 18 to 45 years with PFO and no other cause of brain ischemia, as part of the IPSYS registry (Italian Project on Stroke in Young Adults), who underwent either percutaneous PFO closure or medical therapy for comparative analysis. Primary end point was a composite of ischemic stroke, transient ischemic attack, or peripheral embolism. Secondary end point was brain ischemia. Five hundred and twenty-one patients qualified for the analysis. The primary end point occurred in 15 patients treated with percutaneous PFO closure (7.3%) versus 33 patients medically treated (10.5%; hazard ratio, 0.72; 95% confidence interval, 0.39-1.32; P=0.285). The rates of the secondary end point brain ischemia were also similar in the 2 treatment groups (6.3% in the PFO closure group versus 10.2% in the medically treated group; hazard ratio, 0.64; 95% confidence interval, 0.33-1.21; P=0.168). Closure provided a benefit in patients aged 18 to 36 years (hazard ratio, 0.19; 95% confidence interval, 0.04-0.81; P=0.026) and in those with a substantial right-to-left shunt size (hazard ratio, 0.19; 95% confidence interval, 0.05-0.68; P=0.011).

CONCLUSIONS:

PFO closure seems as effective as medical therapy for secondary prevention of cryptogenic ischemic stroke. Whether device treatment might be more effective in selected cases, such as in patients younger than 37 years and in those with a substantial right-to-left shunt size, deserves further investigation.

• Authors: Alessandro Pezzini, Mario Grassi, Corrado Lodigiani, Rosalba Patella, Carlo Gandolfo, Andrea Zini, Maria Luisa DeLodovici, Maurizio Paciaroni, Massimo Del Sette, Antonella Toriello, Rossella Musolino, Rocco Salvatore Calabrò, Paolo Bovi, Alessandro Adami, Giorgio Silvestrelli, Maria Sessa, Anna Cavallini, Simona Marcheselli, Domenico Marco Bonifati, Nicoletta Checcarelli, Lucia Tancredi, Alberto Chiti, Elisabetta Del Zotto, Giampaolo Tomelleri, Alessandra Spalloni, Elisa Giorli, Paolo Costa, Giacomo Giacalone, Paola Ferrazzi, Loris Poli, Andrea Morotti, Valeria Piras, Maurizia Rasura, Anna Maria Simone, Massimo Gamba, Paolo Cerrato, Maria Luisa Zedde, Giuseppe Micieli, Maurizio Melis, Davide Massucco, Davide Guido, Valeria De Giuli, Silvia Bonaiti, Cataldo D'Amore, Sara La Starza, Licia Iacoviello, Alessandro Padovani, Italian Project on Stroke in Young Adults (IPSYS) Investigators
• Journal: Circulation. Cardiovascular interventions (Circ Cardiovasc Interv) Vol. 9 Issue 9 (09 2016) ISSN: 1941-7632 [Electronic] United States
• PMID: 27582111 (Publication Type: Comparative Study, Journal Article, Multicenter Study, Observational Study, Research Support, Non-U.S. Gov't)
• Copyright: © 2016 American Heart Association, Inc.

Chemical References

• Cardiovascular Agents

Topics

• Adolescent
• Adult
• Age Factors
• Brain Ischemia (diagnosis, etiology, prevention & control)
• Cardiac Catheterization (adverse effects, instrumentation, methods)
• Cardiovascular Agents (adverse effects, therapeutic use)
• Chi-Square Distribution
• Embolism, Paradoxical (diagnosis, etiology, prevention & control)
• Female
• Foramen Ovale, Patent (complications, diagnostic imaging, therapy)
• Humans
• Intracranial Embolism (diagnosis, etiology, prevention & control)
• Italy
• Male
• Middle Aged
• Propensity Score
• Proportional Hazards Models
• Registries
• Risk Factors
• Secondary Prevention (instrumentation, methods)
• Stroke (diagnosis, etiology, prevention & control)
• Time Factors
• Treatment Outcome
• Young Adult