Comparison of medical treatment with percutaneous closure of patent foramen ovale in patients with cryptogenic stroke.
OBJECTIVE
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.
Windecker
Stephan
S
Department of Cardiology, University Hospital, Bern, Switzerland. stephan.windecker@insel.ch
Wahl
Andreas
A
Nedeltchev
Krassen
K
Arnold
Marcel
M
Schwerzmann
Markus
M
Seiler
Christian
C
Mattle
Heinrich P
HP
Meier
Bernhard
B
D000293:Adolescent; D000328:Adult; D000368:Aged; D000925:Anticoagulants / Q000627:therapeutic use; D006328:Cardiac Catheterization; D018572:Disease-Free Survival; D017548:Echocardiography, Transesophageal; D004621:Embolization, Therapeutic / Q000295:instrumentation / Q000379:methods*; D005260:Female; D006344:Heart Septal Defects, Atrial / Q000150:complications / Q000000981:diagnostic imaging / Q000628:therapy*; D006801:Humans; D002546:Ischemic Attack, Transient / Q000453:epidemiology / Q000209:etiology / Q000401:mortality*; D008297:Male; D008499:Medical Records; D008875:Middle Aged; D010975:Platelet Aggregation Inhibitors / Q000627:therapeutic use; D012008:Recurrence; D012189:Retrospective Studies; D013557:Switzerland / Q000453:epidemiology
D000925:Anticoagulants; D010975:Platelet Aggregation Inhibitors