CLINICAL RESEARCH: CLINICAL TRIALS
Comparison of medical treatment with percutaneous closure of patent foramen ovale in patients with cryptogenic stroke
Stephan Windecker, MD*,*,
Andreas Wahl, MD*,
Krassen Nedeltchev, MD ,
Marcel Arnold, MD,
Markus Schwerzmann, MD*,
Christian Seiler, MD, FACC*,
Heinrich P. Mattle, MD and
Bernhard Meier, MD, FACC*,*
* Cardiology
Neurology, University Hospital, Bern,Switzerland
Manuscript received September 7, 2003;
revised manuscript received May 9, 2004,
accepted May 11, 2004.
* Reprint requests and correspondence: Dr. Stephan Windecker, Director of Invasive Cardiology, Swiss Cardiovascular Center Bern, University Hospital, CH-3010 Bern, Switzerland
(Email: stephan.windecker{at}insel.ch).
OBJECTIVES: The purpose of this study was to compare the efficacy of medical treatment with percutaneous closure of patent foramen ovale (PFO).
BACKGROUND: Patients with cryptogenic stroke and PFO are at risk for recurrent cerebrovascular events.
METHODS: We compared the risk of recurrence in 308 patients with cryptogenic stroke and PFO, who were treated either medically (158 patients) or underwent percutaneous PFO closure (150 patients) between 1994 and 2000.
RESULTS: Patients undergoing percutaneous PFO closure had a larger right-to-left shunt (p < 0.001; 95% confidence interval [CI] 1.38 to 3.07) and were more likely to have suffered more than one cerebrovascular event (p = 0.03; 95% CI 1.04 to 2.71). At four years of follow-up, percutaneous PFO closure resulted in a non-significant trend toward risk reduction of death, stroke, or transient ischemic attack (TIA) combined (8.5% vs. 24.3%; p = 0.05; 95% CI 0.23 to 1.01), and of recurrent stroke or TIA (7.8% vs. 22.2%; p = 0.08; 95% CI 0.23 to 1.11) compared with medical treatment. Patients with more than one cerebrovascular event at baseline and those with complete occlusion of PFO were at lower risk for recurrent stroke or TIA after percutaneous PFO closure compared with medically treated patients (7.3% vs. 33.2%; p = 0.01; 95% CI 0.08 to 0.81, and 6.5% vs. 22.2%; p = 0.04; 95% CI 0.14 to 0.99, respectively).
CONCLUSIONS: Percutaneous PFO closure appears at least as effective as medical treatment for prevention of recurrent cerebrovascular events in cryptogenic stroke patients with PFO. It might be more effective than medical treatment in patients with complete closure and more than one cerebrovascular event.
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Abbreviations and Acronyms
| | CI = confidence interval | | PFO = patent foramen ovale | | PICSS = Patent foramen ovale In Cryptogenic Stroke Study | | RR = risk ratio | | TIA = transient ischemic attack |
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