PFO closure vs. medical therapy in cryptogenic stroke or transient ischemic attack: A systematic review and meta-analysis

• Published in: International journal of cardiology Vol. 169; no. 2; pp. 101 - 105
• Main Authors: Ntaios, G, Papavasileiou, V, Makaritsis, K, Michel, P
• Format: Journal Article
• Language: English
• Published: Shannon Elsevier Ireland Ltd 30.10.2013; Elsevier
• Subjects: AMPLATZER PFO Occluder; Biological and medical sciences; Cardiology. Vascular system; Cardiovascular; Congenital heart diseases. Malformations of the aorta, pulmonary vessels and vena cava; Cryptogenic stroke; Foramen Ovale, Patent - drug therapy; Foramen Ovale, Patent - epidemiology; Foramen Ovale, Patent - surgery; Heart; Humans; Ischemic Attack, Transient - drug therapy; Ischemic Attack, Transient - epidemiology; Ischemic Attack, Transient - surgery; Medical sciences; Neurology; Paradoxical embolism; Patent foramen ovale; PFO closure; Pneumology; Pulmonary hypertension. Acute cor pulmonale. Pulmonary embolism. Pulmonary vascular diseases; Randomized Controlled Trials as Topic - methods; Respiratory system : syndromes and miscellaneous diseases; Secondary Prevention - methods; STARFlex device; Stroke - drug therapy; Stroke - epidemiology; Stroke - surgery; Vascular diseases and vascular malformations of the nervous system; Cryptogenic stroke; Paradoxical embolism; Patent foramen ovale; STARFlex device; PFO closure; AMPLATZER PFO Occluder; Closure; Persistent fetal circulation; Cardiovascular disease; Systematic review; Instrumental obliteration; Metaanalysis; Transients; Vascular disease; Respiratory failure; Heart disease; Cardiology; Cerebrovascular disease; Nervous system diseases; Stroke; Respiratory disease; Idiopathic; Instrumentation therapy; Congenital disease; Pulmonary hypertension; Transitory; Cerebral disorder; Medicine; Newborn diseases; Central nervous system disease; Medical device; Ostium secundum; Comparative study
• ISSN: 0167-5273; 1874-1754
• DOI: 10.1016/j.ijcard.2013.08.058

Abstract Background/objectives This study aims to assess whether patent foramen ovale (PFO) closure is superior to medical therapy in preventing recurrence of cryptogenic ischemic stroke or transient ischemic attack (TIA). Methods We searched PubMed for randomized trials which compared PFO closure with medical therapy in cryptogenic stroke/TIA using the items: “stroke or cerebrovascular accident or TIA” and “patent foramen ovale or paradoxical embolism” and “trial or study”. Results Among 650 potentially eligible articles, 3 were included including 2303 patients. There was no statistically significant difference between PFO-closure and medical therapy in ischemic stroke recurrence (1.91% vs. 2.94% respectively, OR: 0.64, 95%CI: 0.37–1.10), TIA (2.08% vs. 2.42% respectively, OR: 0.87, 95%CI: 0.50–1.51) and death (0.60% vs. 0.86% respectively, OR: 0.71, 95%CI: 0.28–1.82). In subgroup analysis, there was significant reduction of ischemic strokes in the AMPLATZER PFO Occluder arm vs. medical therapy (1.4% vs. 3.04% respectively, OR: 0.46, 95%CI: 0.21–0.98, relative-risk-reduction: 53.2%, absolute-risk-reduction: 1.6%, number-needed-to-treat: 61.8) but not in the STARFlex device (2.7% vs. 2.8% with medical therapy, OR: 0.93, 95%CI: 0.45–2.11). Compared to medical therapy, the number of patients with new-onset atrial fibrillation (AF) was similar in the AMPLATZER PFO Occluder arm (0.72% vs. 1.28% respectively, OR: 1.81, 95%CI: 0.60–5.42) but higher in the STARFlex device (0.64% vs. 5.14% respectively, OR: 8.30, 95%CI: 2.47–27.84). Conclusions This meta-analysis does not support PFO closure for secondary prevention with unselected devices in cryptogenic stroke/TIA. In subgroup analysis, selected closure devices may be superior to medical therapy without increasing the risk of new-onset AF, however. This observation should be confirmed in further trials using inclusion criteria for patients with high likelihood of PFO-related stroke recurrence.