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Circulation. 2002;105:2625-2631
Published online before print May 13, 2002, doi: 10.1161/01.CIR.0000017498.88393.44
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(Circulation. 2002;105:2625.)
© 2002 American Heart Association, Inc.


Clinical Investigation and Reports

Effect of Medical Treatment in Stroke Patients With Patent Foramen Ovale

Patent Foramen Ovale in Cryptogenic Stroke Study

Shunichi Homma, MD; Ralph L. Sacco, MD, MS; Marco R. Di Tullio, MD; Robert R. Sciacca, EngScD; J.P. Mohr, MD, for the PFO in Cryptogenic Stroke Study (PICSS) Investigators*

From the Department of Medicine (S.H., M.R.D., R.R.S.) and the Neurological Institute (R.L.S., J.P.M.), Columbia University, New York, NY.

Correspondence to Shunichi Homma, Division of Cardiology, Columbia University, College of Physicians and Surgeons, 630 W 168th St, New York, NY 10032. E-mail sh23{at}columbia.edu

Background Patent foramen ovale (PFO) is associated with stroke, but there are no randomized studies to evaluate the efficacy of antithrombotic therapies.

Methods and Results The PFO in Cryptogenic Stroke Study was a 42-center study that evaluated transesophageal echocardiographic findings in patients randomly assigned to warfarin or aspirin in the Warfarin-Aspirin Recurrent Stroke Study. In this study, 630 stroke patients were enrolled, of whom 312 (49.5%) were randomized to warfarin and 318 (50.5%) to aspirin. Of these, 265 patients experienced cryptogenic stroke and 365 experienced known stroke subtypes. End points were recurrent ischemic stroke or death. PFO was present in 203 patients (33.8%). There was no significant difference in the time to primary end points between those with and those without PFO in the overall population (P=0.84; hazard ratio 0.96; 95% CI 0.62 to 1.48; 2-year event rates 14.8% versus 15.4%) or in the cryptogenic subset (P=0.65; hazard ratio 1.17; 95% CI 0.60 to 2.37; 2-year event rates 14.3% versus 12.7%). There was no significant difference among those with no, small, or large PFO (P=0.41 for small PFO and P=0.16 for large PFO; 2-year event rates for no, small, and large PFO, 15.4%, 18.5%, and 9.5%, respectively). There was no significant difference between patients with isolated PFO and those with PFO in association with atrial septal aneurysm (P=0.84; 2-year event rates 14.5% versus 15.9%). In patients with PFO, there was no significant difference in the time to primary end points between those treated with warfarin and those treated with aspirin (P=0.49; hazard ratio 1.29; 95% CI 0.63 to 2.64; 2-year event rates 16.5% versus 13.2%).

Conclusions On medical therapy, the presence of PFO in stroke patients did not increase the chance of adverse events regardless of PFO size or the presence of atrial septal aneurysm.


Key Words: stroke • anticoagulants • aspirin • echocardiography




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P. Khairy, C. P. O'Donnell, and M. J. Landzberg
Transcatheter Closure versus Medical Therapy of Patent Foramen Ovale and Presumed Paradoxical Thromboemboli: A Systematic Review
Ann Intern Med, November 4, 2003; 139(9): 753 - 760.
[Abstract] [Full Text] [PDF]


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ANN INTERN MEDHome page
J. P. Mohr and S. Homma
Patent Cardiac Foramen Ovale: Stroke Risk and Closure
Ann Intern Med, November 4, 2003; 139(9): 787 - 788.
[Full Text] [PDF]


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HeartHome page
R. D Rakhit
Learning on the Web. Case 2: patent foramen ovale (PFO) and paradoxical embolism.
Heart, November 1, 2003; 89(11): 1362 - 1362.
[Full Text]


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J Am Coll CardiolHome page
S. Homma, R. L. Sacco, M. R. Di Tullio, R. R. Sciacca, J. P. Mohr, and PICSS Investigators
Atrial anatomy in non-cardioembolic stroke patients: Effect of medical therapy
J. Am. Coll. Cardiol., September 17, 2003; 42(6): 1066 - 1072.
[Abstract] [Full Text] [PDF]


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J Am Coll CardiolHome page
R. Castello and T. G. Brott
Patent foramen ovale: friend or foe?
J. Am. Coll. Cardiol., September 17, 2003; 42(6): 1073 - 1075.
[Full Text] [PDF]


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StrokeHome page
C. J. Rodriguez, S. Homma, R. L. Sacco, M. R. Di Tullio, R. R. Sciacca, and J.P. Mohr
Race-Ethnic Differences in Patent Foramen Ovale, Atrial Septal Aneurysm, and Right Atrial Anatomy Among Ischemic Stroke Patients
Stroke, September 1, 2003; 34(9): 2097 - 2102.
[Abstract] [Full Text] [PDF]


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NEJMHome page
M. J. Eimer, N. M. Rajamannan, and S. C. Johnston
Transient Ischemic Attack
N. Engl. J. Med., April 17, 2003; 348(16): 1606 - 1606.
[Full Text] [PDF]


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CirculationHome page
D. J. McGaw, A. M. Ugoni, S. Homma, R. R. Sciacca, M. R. Di Tullio, J. L. Thompson, B. Levin, R. L. Sacco, and J.P. Mohr
Patent Foramen Ovale and Cryptogenic Stroke: The Controversy Continues * Response
Circulation, February 25, 2003; 107 (7): e51 - e51.
[Full Text] [PDF]


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J. Neurol. Neurosurg. PsychiatryHome page
C Stollberger, J Finsterer, M Strandberg, J Hartiala, R J Marttila, and H Helenius
Transoesophageal echocardiography: which stroke patients benefit most from this investigation?
J. Neurol. Neurosurg. Psychiatry, February 1, 2003; 74(2): 283 - 284.
[Full Text]


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StrokeHome page
J. Kennedy and A.M. Buchan
Ever Decreasing Circles: Advances in Antiplatelet Therapy and Anticoagulation
Stroke, February 1, 2003; 34(2): 348 - 350.
[Full Text] [PDF]


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CirculationHome page
B. Meier and J. E. Lock
Contemporary Management of Patent Foramen Ovale
Circulation, January 7, 2003; 107(1): 5 - 9.
[Full Text] [PDF]


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StrokeHome page
A. Pezzini, E. Del Zotto, M. Magoni, A. Costa, S. Archetti, M. Grassi, N. M. Akkawi, A. Albertini, D. Assanelli, L. A. Vignolo, et al.
Inherited Thrombophilic Disorders in Young Adults With Ischemic Stroke and Patent Foramen Ovale
Stroke, January 1, 2003; 34(1): 28 - 33.
[Abstract] [Full Text] [PDF]


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J. Neurol. Neurosurg. PsychiatryHome page
A K Demetriades, K Nedeltchev, M Arnold, H Mattle, S Windecker, and A Wahl
Patent foramen ovale, cerebrovascular risk, and complement
J. Neurol. Neurosurg. Psychiatry, September 1, 2002; 73(3): 351 - 351.
[Full Text] [PDF]


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CirculationHome page
D. R. Holmes Jr and A. Cabalka
Was Your Mother Right--: Do We Always Need to Close the Door?
Circulation, August 27, 2002; 106(9): 1034 - 1036.
[Full Text] [PDF]


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Journal Watch CardiologyHome page
Stroke and Patent Foramen Ovale
Journal Watch Cardiology, August 16, 2002; 2002(816): 7 - 7.
[Full Text]


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JWatch GeneralHome page
Stroke and Patent Foramen Ovale
Journal Watch (General), July 30, 2002; 2002(730): 4 - 4.
[Full Text]


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CirculationHome page
J. L. Halperin and V. Fuster
Patent Foramen Ovale and Recurrent Stroke: Another Paradoxical Twist
Circulation, June 4, 2002; 105(22): 2580 - 2582.
[Full Text] [PDF]