Who benefits from percutaneous closure of patent foramen ovale vs medical therapy for stroke prevention? In-depth and updated meta-analysis of randomized trials

Table 1 Study characteristics

Study name,year	Country of origin	Study design	Indication of PFOC	Total Patients (PFOC + medical therapy), n	Medical therapy	Type of device	Follow-up, in years (mean)
CLOSE[6], 2017	France and Germany	Multicenter, randomized, open-label, superiority trial	Recent stroke due to PFO with atrial septal aneurysm or substantial right-to-left intra-atrial shunt	6631 (238 + 235)	Antiplatelet therapy (aspirin + clopidogrel)1	11 different devices	5.4 PFOC, 5.2 AC-AP
CLOSURE I[11], 2012	United States and Canada	Multicenter, randomized, open-label trial	Stroke or TIA within 6 mo	909 (447 + 462)	Warfarin, aspirin or both	STARFlex device	2
PC Trial[9], 2013	Europe, Canada, Brazil, and Australia	Multicenter, randomized, superiority trial	Stroke, TIA or systemic thromboembolism	414 (204 + 210)	Aspirin+ ticlopidine/clopidogrel	Amplatzer PFO occluder	4.1 PFOC, 4.0 AC/AP
REDUCE[8], 2017	Europe and United States	Multinational, prospective, randomized, controlled, open-label trial	Stroke within 180 d	664 (441 + 223)	Aspirin, aspirin + dipyridamole, or clopidogrel	Helex or Cardioform Septal Occluder	3.2
RESPECT[7], 2017	United States and Canada	Multicenter, randomized, open-label, controlled clinical trial	Stroke within 270 d	980 (499 + 481)	Aspirin + clopidogrel	Amplatzer PFO occluder	5.9
DEFENCE PFO[14], 2018	South Korea	Multicenter, randomized, open-label, superiority	Ischemic stroke in past 6 mos	120 (60 + 60)	Aspirin, aspirin + clopidogrel, aspirin + cilostazol, or warfarin	Amplatzer PFO occluder	2.8

¹There were patients who received anticoagulation alone but the comparator for that arm was antiplatelet therapy not PFOC. AC: Anticoagulation; AP: Anti-platelet; PFOC: Patent foramen ovale closure.