Patent foramen ovale closure reduces recurrent stroke risk in cryptogenic stroke: A systematic review and meta-analysis of randomized controlled trials

Table 2 Details of the included randomized controlled trials

Study name	Type of study	Devices used	Follow-up (median or mean), (mo)	PFO closure device	Medical therapy	Primary composite end point
CLOSE	Randomized multicenter	Amplatz PFO Occluder or Cribriform; Starflex; CardioSeal; Intrasept PFO; PFOStar; Helex; Premere; PFO occluder OCCLUTECH; PFO occluder GORE (GSO)	64	238	235	Fatal or nonfatal stroke
CLOSURE I	Prospective, multicenter, randomized, open-label, two-group superiority trial	STARFlex device (NMT Medical)	22	447	462	Composite of stroke or TIA during 2 yr of follow-up, death from any cause during the first 30 d, and death from neurologic causes between 31 d and 2 yr
PC	Multicenter, multinational, randomized, clinical trial	Amplatzer PFO Occluder (St. Jude Medical)	54	204	210	Composite of death, nonfatal stroke, TIA, or peripheral embolism
REDUCE	Multinational, randomized, clinical trial	Gore Helex or Gore Cardioform (WL Gore and Associates) septal occluders	38	441	223	Freedom from recurrent clinical ischemic stroke through at least 24 mo and incidence of new brain infarct
RESPECT	Prospective, multicenter, controlled, randomized, open-label clinical trial	Amplatzer PFO Occluder	71	499	481	Recurrent nonfatal ischemic stroke, fatal ischemic stroke, or early death

CLOSE: Patent Foramen Ovale Closure or Anticoagulants vs Antiplatelet Therapy to Prevent Stroke Recurrence; CLOSURE I: Evaluation of the STARFlex Septal Closure System in Patients with a Stroke and/or Transient Ischemic Attack due to Presumed Paradoxical Embolism through a Patent Foramen Ovale; PC: Percutaneous Closure of Patent Foramen Ovale Using the Amplatzer PFO Occluder with Medical Treatment in Patients with Cryptogenic Embolism; REDUCE: GORE^® HELEX^® Septal Occluder/GORE^® CARDIOFORM Septal Occluder and Antiplatelet Medical Management for Reduction of Recurrent Stroke or Imaging-Confirmed TIA in Patients With Patent Foramen Ovale (PFO); RESPECT: Randomized Evaluation of Recurrent Stroke Comparing PFO Closure to Established Current Standard of Care Treatment; PFO: Patent foramen ovale; TIA: Transient ischemic attack.