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PFO closure failed to improve cryptogenic stroke risk
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Patent foramen ovale closure failed to improve outcomes in cryptogenic stroke compared with medical therapy, according to an analysis of several randomized and observational studies. However, the study also found that the Amplatzer PFO Occluder significantly reduced stroke vs. medical management.
Researchers of the study sought to update evidence emerging from randomized and observational studies comparing PFO with medical therapy in cryptogenic stroke. The current analysis included studies published or presented through March 2013. There were 2,303 patients from three randomized clinical trials and 2,231 patients from 11 observational studies included in the study.
In the randomized trial cohort, PFO closure compared with medical therapy did not reduce the risk for stroke (HR=0.62; 95% CI, 0.34-1.11; P=.10). The researchers reported no significant heterogeneity or systematic bias.
Transient ischemic attacks did not differ significantly between the two groups (HR=0.77; 95% CI, 0.46-1.32; P=.34). Also, there was no study-related mortality.
Stroke risk was significantly reduced in a pooled analysis of studies involving the Amplatzer PFO Occluder (AGA/St. Jude Medical; HR=0.44; 95% CI, 0.20-0.95; P=.04).
The Starflex (NMT Medical) device was associated with improved procedural success, new onset AF and cardiac thrombus compared with the Amplatzer device.
PFO closure was associated with a significant reduction in recurrent stroke risk in observational studies that carried a high potential for confounding baseline factors (HR=0.23; 95% CI, 0.11-0.49; P<.01). Furthermore, PFO closure carried no excess risk on transient ischemic attacks in the observational cohorts.
“In [randomized controlled trials], unlike observational studies, PFO closure compared with medical therapy failed to achieve a statistically significant reduction in recurrent stroke,” the researchers concluded. “However, pooling [randomized controlled trials] of the Amplatzer PFO Occluder device yielded a statistically significant reduction in stroke over medical treatment that may warrant further investigation.”
Disclosure: The researchers report no relevant financial disclosures.
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