Percutaneous Closure of Patent Foramen Ovale in Patients With Paradoxical Embolism

To the Editor: Windecker et al reported a series of 80 stroke patients with patent foramen ovale (PFO) treated by percutaneous closure1 and recommended a randomized trial. The accompanying editorial is less measured.2 Its author does not mention antiplatelet treatment as a management option, despite acknowledging that PFO is “almost invariably benign.” He postulates that a randomized trial should compare anticoagulation and closure and that young patients with cryptogenic stroke and large PFO should currently be referred for closure if unsuitable for anticoagulant therapy. The low recurrence rate in patients with cryptogenic stroke and PFO presents difficulties in trial design. A benign natural history means that large randomized trials will be required to demonstrate a significant benefit of interventional techniques. It also has implications for preliminary claims made on the basis of observational data. In the study by Windecker et al, annual risk …