Elsayed Abo-Salem1, Bernard Chaitman1, Tarek Helmy1, Eric Adjei Boakye2, Hassan Alkhawam3, Michael Lim1. 1. Center for Comprehensive Cardiovascular Care, Saint Louis University School of Medicine, St Louis University Hospital, 3635 Vista Avenue, FDT 13th Floor, Cardiology, St. Louis, MO, 63110, USA. 2. Saint Louis University Center for Health Outcomes Research, Saint Louis University, St. Louis, MO, USA. 3. Center for Comprehensive Cardiovascular Care, Saint Louis University School of Medicine, St Louis University Hospital, 3635 Vista Avenue, FDT 13th Floor, Cardiology, St. Louis, MO, 63110, USA. alkhawamh@slu.edu.
Abstract
BACKGROUND: PFO is more common in cases with cryptogenic stroke compared to cases with no stroke or stroke of identified etiology. Several randomized controlled trials (RCTs) comparing PFO closure with medical therapy have been published with controversial findings. METHODS: PubMed, Embase and Cochrane library databases were searched for RCT comparing PFO closure with medical therapy including antiplatelet therapy (aspirin or clopidogrel or combination) or anticoagulation. We identified 5 trials, including 3627 cases. The mean duration of follow-up was 4 years. Relative risk (RR) and 95% confidence intervals (CI) were calculated using fixed and random-effects models. RESULTS: There was a significant reduction in the incidence of stroke among the PFO closure group compared to medical therapy group, 2.0 versus 4.2%, RR 0.48; 95% CI (0.3, 0.7), p < 0.001. The incidence of AF was higher in the PFO closure group compared to medical therapy group, 4.2 versus 0.7%, respectively, RR 5.9, 95% CI (3, 11), p < 0.001. After exclusion of oral anticoagulants cases (19%), analysis showed a lower incidence of stroke in the PFO closure group (2%) compared to antiplatelet therapy (5.2%), RR 0.4; 95% CI (0.3, 0.6), p < 0.001. There was no significant difference between both groups in the incidence of transient ischemic attacks or all-cause deaths. CONCLUSION: PFO closure results in a significant reduction in the recurrence of ischemic stroke compared to medical therapy alone, primarily antiplatelet, among cases with PFO and cryptogenic stroke.
BACKGROUND:PFO is more common in cases with cryptogenic stroke compared to cases with no stroke or stroke of identified etiology. Several randomized controlled trials (RCTs) comparing PFO closure with medical therapy have been published with controversial findings. METHODS: PubMed, Embase and Cochrane library databases were searched for RCT comparing PFO closure with medical therapy including antiplatelet therapy (aspirin or clopidogrel or combination) or anticoagulation. We identified 5 trials, including 3627 cases. The mean duration of follow-up was 4 years. Relative risk (RR) and 95% confidence intervals (CI) were calculated using fixed and random-effects models. RESULTS: There was a significant reduction in the incidence of stroke among the PFO closure group compared to medical therapy group, 2.0 versus 4.2%, RR 0.48; 95% CI (0.3, 0.7), p < 0.001. The incidence of AF was higher in the PFO closure group compared to medical therapy group, 4.2 versus 0.7%, respectively, RR 5.9, 95% CI (3, 11), p < 0.001. After exclusion of oral anticoagulants cases (19%), analysis showed a lower incidence of stroke in the PFO closure group (2%) compared to antiplatelet therapy (5.2%), RR 0.4; 95% CI (0.3, 0.6), p < 0.001. There was no significant difference between both groups in the incidence of transient ischemic attacks or all-cause deaths. CONCLUSION:PFO closure results in a significant reduction in the recurrence of ischemic stroke compared to medical therapy alone, primarily antiplatelet, among cases with PFO and cryptogenic stroke.
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