More Inconclusive Results from PFO-Closure Trials

Two new studies fail to provide strong evidence either for or against PFO correction to prevent recurrent cryptogenic stroke.

Patent foramen ovale (PFO) is more prevalent in patients with cryptogenic stroke than in the general population, but can correction of the PFO reduce stroke incidence? Findings from the CLOSURE I trial of the STARFlex PFO-closure device after cryptogenic stroke showed no significant reduction in the rate of recurrent stroke compared with medical therapy (JW Neurol Mar 14 2012). Now, results are available from two randomized trials of another device (the Amplatzer PFO Occluder).

In the manufacturer-funded PC Trial, investigators at 29 European sites assigned 414 patients (mean age, 44) with a neuroradiologically confirmed PFO and cryptogenic stroke, transient ischemic attack (TIA), or peripheral thromboembolism to receive the PFO-closure devi…

Reviewing Authors

Harlan M. Krumholz, MD, SM

Disclosures

Consultant/Advisory BoardUnited Healthcare; Element Science; Eyedentifeye, F-Prime

EquityHugo Health; Refactor Health; Element Science

Grant/Research SupportPfizer; Agency for Healthcare Research and Quality; Janssen Research and Development, National Institute of Biomedical Imaging and Engineering; National Heart, Lung, and Blood Institute; Centers for Disease Control and Prevention; National Cancer Institute; American Heart Association

Harlan M. Krumholz, MD, SM

Disclosures

Consultant/Advisory BoardUnited Healthcare; Element Science; Eyedentifeye, F-Prime

EquityHugo Health; Refactor Health; Element Science

S. Andrew Josephson, MD

Disclosures

Editorial boardsThe Neurohospitalist; Continuum Audio (American Academy of Neurology)

Leadership positions in professional societiesThe Neurohospitalist Society (Vice President)

S. Andrew Josephson, MD

Disclosures

Editorial boardsThe Neurohospitalist; Continuum Audio (American Academy of Neurology)

Leadership positions in professional societiesThe Neurohospitalist Society (Vice President)