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)

A. Pezzini, M. Grassi, Corrado Lodigiani, R. Patella, Carlo Gandolfo, Andrea Zini, M. Luisa Delodovici, Maurizio Paciaroni, Massimo Del Sette, Antonella Toriello, R. Musolino, Rocco Salvatore Calabrò, P. Bovi, Alessandro Adami, Giorgio Silvestrelli, Maria Sessa, Anna Maria Cavallini, Simona Marcheselli, Domenico Marco Bonifati, N. CheccarelliL. Tancredi, Alberto Chiti, Elisabetta Del Zotto, G. Tomelleri, A. Spalloni, Elisa Giorli, Paolo Costa, Giacomo Giacalone, Paola Ferrazzi, Loris Poli, Andrea Morotti, Valeria Piras, Maurizia Rasura, Anna Maria Simone, Massimo Gamba, Paolo Cerrato, M. Zedde, Giuseppe Micieli, Maurizio Melis, Davide Massucco, Davide Guido, Valeria De Giuli, Silvia Bonaiti, Cataldo D'Amore, S. La Starza, Licia Iacoviello, A. Padovani

Research output: Contribution to journalArticle

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.

Original languageEnglish
Article numbere003470
JournalCirculation: Cardiovascular Interventions
Volume9
Issue number9
DOIs
Publication statusPublished - Sep 1 2016

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Patent Foramen Ovale
Propensity Score
Registries
Young Adult
Stroke
Brain Ischemia
Confidence Intervals
Secondary Prevention
Embolism
Therapeutics
Transient Ischemic Attack
Equipment and Supplies

Keywords

  • atrial septum
  • follow-up studies
  • patent foramen ovale
  • secondary prevention
  • stroke

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

Cite this

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). / Pezzini, A.; Grassi, M.; Lodigiani, Corrado; Patella, R.; Gandolfo, Carlo; Zini, Andrea; Delodovici, M. Luisa; Paciaroni, Maurizio; Del Sette, Massimo; Toriello, Antonella; Musolino, R.; Calabrò, Rocco Salvatore; Bovi, P.; Adami, Alessandro; Silvestrelli, Giorgio; Sessa, Maria; Cavallini, Anna Maria; Marcheselli, Simona; Marco Bonifati, Domenico; Checcarelli, N.; Tancredi, L.; Chiti, Alberto; Del Zotto, Elisabetta; Tomelleri, G.; Spalloni, A.; Giorli, Elisa; Costa, Paolo; Giacalone, Giacomo; Ferrazzi, Paola; Poli, Loris; Morotti, Andrea; Piras, Valeria; Rasura, Maurizia; Simone, Anna Maria; Gamba, Massimo; Cerrato, Paolo; Zedde, M.; Micieli, Giuseppe; Melis, Maurizio; Massucco, Davide; Guido, Davide; De Giuli, Valeria; Bonaiti, Silvia; D'Amore, Cataldo; La Starza, S.; Iacoviello, Licia; Padovani, A.

In: Circulation: Cardiovascular Interventions, Vol. 9, No. 9, e003470, 01.09.2016.

Research output: Contribution to journalArticle

Pezzini, A, Grassi, M, Lodigiani, C, Patella, R, Gandolfo, C, Zini, A, Delodovici, ML, Paciaroni, M, Del Sette, M, Toriello, A, Musolino, R, Calabrò, RS, Bovi, P, Adami, A, Silvestrelli, G, Sessa, M, Cavallini, AM, Marcheselli, S, Marco Bonifati, D, Checcarelli, N, Tancredi, L, Chiti, A, Del Zotto, E, Tomelleri, G, Spalloni, A, Giorli, E, Costa, P, Giacalone, G, Ferrazzi, P, Poli, L, Morotti, A, Piras, V, Rasura, M, Simone, AM, Gamba, M, Cerrato, P, Zedde, M, Micieli, G, Melis, M, Massucco, D, Guido, D, De Giuli, V, Bonaiti, S, D'Amore, C, La Starza, S, Iacoviello, L & Padovani, A 2016, '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)', Circulation: Cardiovascular Interventions, vol. 9, no. 9, e003470. https://doi.org/10.1161/CIRCINTERVENTIONS.115.003470
Pezzini, A. ; Grassi, M. ; Lodigiani, Corrado ; Patella, R. ; Gandolfo, Carlo ; Zini, Andrea ; Delodovici, M. Luisa ; Paciaroni, Maurizio ; Del Sette, Massimo ; Toriello, Antonella ; Musolino, R. ; Calabrò, Rocco Salvatore ; Bovi, P. ; Adami, Alessandro ; Silvestrelli, Giorgio ; Sessa, Maria ; Cavallini, Anna Maria ; Marcheselli, Simona ; Marco Bonifati, Domenico ; Checcarelli, N. ; Tancredi, L. ; Chiti, Alberto ; Del Zotto, Elisabetta ; Tomelleri, G. ; Spalloni, A. ; Giorli, Elisa ; Costa, Paolo ; Giacalone, Giacomo ; Ferrazzi, Paola ; Poli, Loris ; Morotti, Andrea ; Piras, Valeria ; Rasura, Maurizia ; Simone, Anna Maria ; Gamba, Massimo ; Cerrato, Paolo ; Zedde, M. ; Micieli, Giuseppe ; Melis, Maurizio ; Massucco, Davide ; Guido, Davide ; De Giuli, Valeria ; Bonaiti, Silvia ; D'Amore, Cataldo ; La Starza, S. ; Iacoviello, Licia ; Padovani, A. / 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). In: Circulation: Cardiovascular Interventions. 2016 ; Vol. 9, No. 9.
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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.",
keywords = "atrial septum, follow-up studies, patent foramen ovale, secondary prevention, stroke",
author = "A. Pezzini and M. Grassi and Corrado Lodigiani and R. Patella and Carlo Gandolfo and Andrea Zini and Delodovici, {M. Luisa} and Maurizio Paciaroni and {Del Sette}, Massimo and Antonella Toriello and R. Musolino and Calabr{\`o}, {Rocco Salvatore} and P. Bovi and Alessandro Adami and Giorgio Silvestrelli and Maria Sessa and Cavallini, {Anna Maria} and Simona Marcheselli and {Marco Bonifati}, Domenico and N. Checcarelli and L. Tancredi and Alberto Chiti and {Del Zotto}, Elisabetta and G. Tomelleri and A. Spalloni and Elisa Giorli and Paolo Costa and Giacomo Giacalone and Paola Ferrazzi and Loris Poli and Andrea Morotti and Valeria Piras and Maurizia Rasura and Simone, {Anna Maria} and Massimo Gamba and Paolo Cerrato and M. Zedde and Giuseppe Micieli and Maurizio Melis and Davide Massucco and Davide Guido and {De Giuli}, Valeria and Silvia Bonaiti and Cataldo D'Amore and {La Starza}, S. and Licia Iacoviello and A. Padovani",
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TY - JOUR

T1 - Propensity Score-Based Analysis of Percutaneous Closure Versus Medical Therapy in Patients with Cryptogenic Stroke and Patent Foramen Ovale

T2 - The IPSYS Registry (Italian Project on Stroke in Young Adults)

AU - Pezzini, A.

AU - Grassi, M.

AU - Lodigiani, Corrado

AU - Patella, R.

AU - Gandolfo, Carlo

AU - Zini, Andrea

AU - Delodovici, M. Luisa

AU - Paciaroni, Maurizio

AU - Del Sette, Massimo

AU - Toriello, Antonella

AU - Musolino, R.

AU - Calabrò, Rocco Salvatore

AU - Bovi, P.

AU - Adami, Alessandro

AU - Silvestrelli, Giorgio

AU - Sessa, Maria

AU - Cavallini, Anna Maria

AU - Marcheselli, Simona

AU - Marco Bonifati, Domenico

AU - Checcarelli, N.

AU - Tancredi, L.

AU - Chiti, Alberto

AU - Del Zotto, Elisabetta

AU - Tomelleri, G.

AU - Spalloni, A.

AU - Giorli, Elisa

AU - Costa, Paolo

AU - Giacalone, Giacomo

AU - Ferrazzi, Paola

AU - Poli, Loris

AU - Morotti, Andrea

AU - Piras, Valeria

AU - Rasura, Maurizia

AU - Simone, Anna Maria

AU - Gamba, Massimo

AU - Cerrato, Paolo

AU - Zedde, M.

AU - Micieli, Giuseppe

AU - Melis, Maurizio

AU - Massucco, Davide

AU - Guido, Davide

AU - De Giuli, Valeria

AU - Bonaiti, Silvia

AU - D'Amore, Cataldo

AU - La Starza, S.

AU - Iacoviello, Licia

AU - Padovani, A.

PY - 2016/9/1

Y1 - 2016/9/1

N2 - 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.

AB - 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.

KW - atrial septum

KW - follow-up studies

KW - patent foramen ovale

KW - secondary prevention

KW - stroke

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