Jacob A Udell1, Alexander R Opotowsky2, Paul Khairy3, Candice K Silversides4, David J Gladstone5, Patrick T O'Gara6, Michael J Landzberg2. 1. Cardiovascular Division, Department of Medicine, Women's College Hospital and University of Toronto, Toronto, Ontario, Canada. Electronic address: jay.udell@utoronto.ca. 2. Department of Cardiology, Boston Children's Hospital, and Harvard Medical School, Boston, Massachusetts, USA; Cardiovascular Division, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts, USA. 3. Department of Cardiology, Boston Children's Hospital, and Harvard Medical School, Boston, Massachusetts, USA; Cardiovascular Division, Department of Medicine, Montreal Heart Institute and University of Montreal, Montreal, Québec, Canada. 4. Cardiovascular Division, Department of Medicine, Mount Sinai Hospital and Toronto General Hospital, University of Toronto, Toronto, Ontario, Canada. 5. Division of Neurology and Regional Stroke Centre, Department of Medicine, Sunnybrook Health Sciences Centre and University of Toronto, Toronto, Ontario, Canada. 6. Cardiovascular Division, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts, USA.
Abstract
BACKGROUND: Patent foramen ovale (PFO) might be a risk factor for unexplained ("cryptogenic") stroke or transient ischemic attack (TIA). We sought to determine the efficacy and safety of transcatheter PFO closure compared with antithrombotic therapy for secondary prevention of cerebrovascular events among patients with cryptogenic stroke. METHODS: We performed a systematic review and meta-analysis of MedLine and Embase (from inception to March 2013) for randomized controlled trials (RCTs) that compared transcatheter PFO closure with medical therapy in subjects with cryptogenic stroke. Data were independently extracted on trial conduct quality, baseline characteristics, efficacy, and safety events from published articles and appendices. Risk ratios (RRs) and 95% confidence intervals (CIs) for the composite of stroke or TIA, and adverse cardiovascular events including atrial fibrillation/flutter were constructed. RESULTS: Three RCTs of 2303 subjects with previous stroke, TIA, or systemic arterial embolism (mean age, 45.7 years; 47.3% women; mean follow-up, 2.6 years) were included. PFO closure did not significantly reduce the risk of recurrent stroke/TIA (3.7% vs 5.2%; RR, 0.73; 95% CI, 0.50-1.07; P = 0.10); however, an increased risk of incident atrial fibrillation/flutter was detected (3.8% vs 1.0%; RR, 3.67; 95% CI, 1.95-6.89; P < 0.0001). No significant heterogeneity was detected for any end point among subgroups of patients stratified according to age, sex, index cardiovascular event, device type, interatrial shunt size, and presence of an atrial septal aneurysm (all P interactions ≥ 0.09). CONCLUSIONS: Meta-analysis of RCTs that assessed transcatheter PFO closure for secondary prevention of cerebrovascular events in subjects with cryptogenic stroke does not demonstrate benefit compared with antithrombotic therapy, and suggests potential risks.
BACKGROUND:Patent foramen ovale (PFO) might be a risk factor for unexplained ("cryptogenic") stroke or transient ischemic attack (TIA). We sought to determine the efficacy and safety of transcatheter PFO closure compared with antithrombotic therapy for secondary prevention of cerebrovascular events among patients with cryptogenic stroke. METHODS: We performed a systematic review and meta-analysis of MedLine and Embase (from inception to March 2013) for randomized controlled trials (RCTs) that compared transcatheter PFO closure with medical therapy in subjects with cryptogenic stroke. Data were independently extracted on trial conduct quality, baseline characteristics, efficacy, and safety events from published articles and appendices. Risk ratios (RRs) and 95% confidence intervals (CIs) for the composite of stroke or TIA, and adverse cardiovascular events including atrial fibrillation/flutter were constructed. RESULTS: Three RCTs of 2303 subjects with previous stroke, TIA, or systemic arterial embolism (mean age, 45.7 years; 47.3% women; mean follow-up, 2.6 years) were included. PFO closure did not significantly reduce the risk of recurrent stroke/TIA (3.7% vs 5.2%; RR, 0.73; 95% CI, 0.50-1.07; P = 0.10); however, an increased risk of incident atrial fibrillation/flutter was detected (3.8% vs 1.0%; RR, 3.67; 95% CI, 1.95-6.89; P < 0.0001). No significant heterogeneity was detected for any end point among subgroups of patients stratified according to age, sex, index cardiovascular event, device type, interatrial shunt size, and presence of an atrial septal aneurysm (all P interactions ≥ 0.09). CONCLUSIONS: Meta-analysis of RCTs that assessed transcatheter PFO closure for secondary prevention of cerebrovascular events in subjects with cryptogenic stroke does not demonstrate benefit compared with antithrombotic therapy, and suggests potential risks.
Authors: Lei Chen; Wenjun Deng; Igor Palacios; Ignacio Inglessis-Azuaje; David McMullin; Dong Zhou; Eng H Lo; Ferdinando Buonanno; MingMing Ning Journal: J Investig Med Date: 2016-03-17 Impact factor: 2.895
Authors: Gary Tse; William K K Wu; Jenny Chi Ling Lai; Mengqi Gong; George Bazoukis; Wing Tak Wong; Sunny Hei Wong; Konstantinos Lampropoulos; Adrian Baranchuk; Lap Ah Tse; Yunlong Xia; Guangping Li; Martin C S Wong; Yat Sun Chan; Nan Mu; Mei Dong; Tong Liu Journal: F1000Res Date: 2017-12-27