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CLOSURE I: PFO closure device not superior to medical therapy
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American Heart Association Scientific Sessions 2010
CHICAGO — Percutaneous closure of the patent foramen ovale with a septal closure device was no more effective than medical therapy in the prevention of secondary transient ischemic attack and stroke.
The CLOSURE I trial, a prospective, multi-center, randomized, open-label, two-arm superiority study, included 909 patients with a cryptogenic stroke or transient ischemic attack (TIA) and a patent foramen ovale (PFO) within 6 months of randomization. Patients aged 60 years or younger were randomly assigned to closure with StarFlex (NMT Medical) and 6 months of aspirin and clopidogrel followed by 18 months of aspirin (n=447) or best medical therapy consisting of 24 months of aspirin, warfarin or a combination of the two (n=462).
The primary endpoint was incidence of stroke or TIA at 2 years, all-cause mortality for the first 30 days and neurological mortality between 31 days and 2 years. Follow-up occurred at 1 month, 6 months, 12 months and 24 months.
PFO closure was not superior to medical therapy alone in reducing the 2-year primary endpoint (5.9% vs. 7.7%; P=.30). In addition, the rate of stroke was comparable between the two arms (3.1% for closure vs. 3.4% for medical therapy alone; P=.77), and a Kaplan-Meier curve revealed no statistically significant benefit in either arm over time.
Similarly, there was no difference between arms when the researchers observed outcomes in patients based on baseline shunt or the presence or absence of atrial septal aneurysm.
The rate of adverse events was nearly 17% in both arms (16.9% for closure and 16.6% for medical therapy) but the type of adverse event differed among treatment arms. Procedural-related events accounted for 3.2% of adverse events in the closure arm vs. no procedural events in the medical therapy arm. The rate of atrial fibrillation was also higher in the procedure arm compared with placebo (5.7% vs. 0.7%; P<.001). According to Anthony J. Furlan, MD, who presented results from the trial in a press conference, most AF occurences were periprocedural.
“When we looked at the causes of the recurrent events (stroke or TIA), we could find an explanation that had nothing to do with paradoxical embolism in about 80% of patients,” Furlan, who is the Gilbert Humphrey Professor of Neurology and co-director of the University Hospitals Case Medical Center Neurological Institute, Case Western Reserve University School of Medicine in Cleveland, said.
According to Furlan, in many cryptogenic patients with recurrent stroke, the stroke was not due to paradoxical embolism.
Furlan is a consultant for NMT Medical and the principal investigator for the CLOSURE I trial. – by Stacey L. Fisher
For more information:
- Furlan A. LBCT II, Abstract 21572. Presented at: American Heart Association Scientific Sessions 2010; Nov. 13-17; Chicago.
CLOSURE I clearly showed that in patients with stroke of unknown cause and PFO with cytogenic stroke there is no need to close the PFO systematically. These results should now be translated to practice for the million patients with stroke of unknown cause and PFO. On a case-by-case basis, however, after careful evaluation by a vascular neurologist and cardiologist, we may select some patients with a potential causal relationship between PFO and stroke embolism. However, these cases are likely to be very rare.
– Pierre Amarenco, MD,
Department of Neurology and Stroke Center, Bichat Hospital, Paris
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