Patent Foramen Ovale Closure or Antiplatelet Therapy for Cryptogenic Stroke

Abstract

Among patients with a PFO who had had a cryptogenic stroke, the risk of subsequent ischemic stroke was lower among those assigned to PFO closure combined with antiplatelet therapy than among those assigned to antiplatelet therapy alone; however, PFO closure was associated with higher rates of device complications and atrial fibrillation. (Funded by W.L. Gore and Associates; Gore REDUCE ClinicalTrials.gov number, NCT00738894 .).

Closure, Anticoagulation, or Antiplatelet Therapy for Cryptogenic Stroke With Patent Foramen Ovale: Systematic Review of Randomized Trials, Sequential Meta‐Analysis, and New Insights From the CLOSE Study

“…We identified 9 articles reporting the results of 8 different RCTs meeting the inclusion criteria 7, 8, 9, 10, 11, 12, 30, 31. Four studies (CLOSURE I,7 PC trial,8 RESPECT,10 and DEFENSE‐PFO13) compared PFO closure with antithrombotic therapy (oral anticoagulation or antiplatelet therapy at the discretion of the investigator).…”

“…Four studies (CLOSURE I,7 PC trial,8 RESPECT,10 and DEFENSE‐PFO13) compared PFO closure with antithrombotic therapy (oral anticoagulation or antiplatelet therapy at the discretion of the investigator). Two studies (Gore REDUCE11 and CLOSE12) compared PFO closure with antiplatelet therapy. The CLOSE study also allowed the post hoc comparison of PFO closure versus anticoagulation.…”

“…The meta‐analysis of PFO closure versus antithrombotic therapy comprised a total of 3560 patients from 6 studies 7, 8, 10, 11, 12, 13. Key features of the design of included trials are summarized in Table.…”

“…The end points of interest for the present meta‐analysis were defined before starting the literature search. Our primary end point was fatal or nonfatal recurrent stroke 11. Secondary end points were occurrence of a transient ischemic attack (TIA),18 all‐cause mortality, major bleeding, major procedural complication, and new‐onset atrial fibrillation.…”

“…Three randomized controlled trials (RCTs) published in 2012 and 2013 (CLOSURE I (STARFlex Septal Closure System in Patients with a Stroke and/or Transient Ischemic Attack due to Presumed Paradoxical Embolism through a Patent Foramen Ovale),7 PC Trial (Clinical Trial Comparing Percutaneous Closure of Patent Foramen Ovale Using the Amplatzer PFO Occluder with Medical Treatment in Patients with Cryptogenic Embolism),8 and RESPECT (Randomized Evaluation of Recurrent Stroke Comparing PFO Closure to Established Current Standard of Care Treatment)9) failed to demonstrate the superiority of PFO closure over antithrombotic therapy (antiplatelet therapy or anticoagulants) to prevent recurrent stroke. Recently, the long‐term analysis of the RESPECT trial10 and 3 other RCTs (Gore REDUCE (Gore Helex septal occluder and antiplatelet medical management for reduction of recurrent stroke or imaging‐confirmed transient ischemic attack in patients with patent foramen ovale),11 CLOSE (Patent Foramen Ovale Closure or Anticoagulants versus Antiplatelet Therapy to Prevent Stroke Recurrence),12 and DEFENSE‐PFO (Device Closure Versus Medical Therapy for Cryptogenic Stroke Patients With High Risk Patent Foramen Ovale)13) reported a lower incidence rate of recurrent stroke in patients randomized to PFO closure compared with controls. We performed a systematic review and meta‐analysis of all randomized data allowing the direct comparison of PFO closure, anticoagulation, and antiplatelet therapy to prevent recurrent stroke in patients with cryptogenic stroke and PFO.…”