Lohit Garg1, Affan Haleem2, Shweta Varade3, Keithan Sivakumar3, Mahek Shah2, Brijesh Patel2, Manyoo Agarwal4, Sahil Agrawal5, Megan Leary6, Bryan Kluck7. 1. Department of Cardiology, Lehigh Valley Health Network, Allentown, Pennsylvania. Electronic address: garg.medicine@gmail.com. 2. Department of Cardiology, Lehigh Valley Health Network, Allentown, Pennsylvania. 3. Department of Neurology, Lehigh Valley Health Network, Allentown, Pennsylvania. 4. Department of Internal Medicine, University of Tennessee Medical Center, Memphis, Tennessee. 5. Department of Cardiology, St. Luke's University Health Network, Bethlehem, Pennsylvania. 6. Department of Neurology, Lehigh Valley Health Network, Allentown, Pennsylvania; Morsani College of Medicine, University of South Florida, Tampa, Florida. 7. Department of Cardiology, Lehigh Valley Health Network, Allentown, Pennsylvania; Morsani College of Medicine, University of South Florida, Tampa, Florida.
Abstract
BACKGROUND: The clinical benefit of patent foramen ovale (PFO) closure after cryptogenic stroke has been a topic of debate for decades. Recently, 3 randomized controlled trials of PFO closure in patients with cryptogenic stroke demonstrated a significantly reduced risk of recurrent stroke compared with standard medical therapy alone. This meta-analysis was performed to clarify the efficacy of PFO closure for future stroke prevention in this population. METHODS: A systematic literature search was undertaken. Published pooled data from 5 large randomized clinical trials (CLOSE, RESPECT, Gore REDUCE, CLOSURE I, and PC) were combined and then subsequently analyzed. Enrolled patients with cryptogenic stroke were assigned to receive standard medical care or to undergo endovascular PFO closure, with a primary outcome of reduction in stroke recurrence rate. Secondary outcomes included rates of transient ischemic attack (TIA), composite outcome of stroke, TIA, and death from all causes, and rates of atrial fibrillation events. RESULTS: We analyzed data for 3412 patients. Transcatheter PFO closure resulted in a statistically significant reduced rate of recurrent stroke, compared with medication alone. Patients undergoing closure were 58% less likely to have another stroke. The number needed to treat with PFO closure to reduce recurrent stroke for 1 patient was 40. CONCLUSIONS: Endovascular PFO closure was associated with a reduced risk of recurrent stroke in patients with a prior cryptogenic cerebral infarct. Although the absolute stroke reduction was small, these findings are clinically significant, given the young age of this patient population and the patients' lifetime risk of recurrent stroke.
BACKGROUND: The clinical benefit of patent foramen ovale (PFO) closure after cryptogenic stroke has been a topic of debate for decades. Recently, 3 randomized controlled trials of PFO closure in patients with cryptogenic stroke demonstrated a significantly reduced risk of recurrent stroke compared with standard medical therapy alone. This meta-analysis was performed to clarify the efficacy of PFO closure for future stroke prevention in this population. METHODS: A systematic literature search was undertaken. Published pooled data from 5 large randomized clinical trials (CLOSE, RESPECT, Gore REDUCE, CLOSURE I, and PC) were combined and then subsequently analyzed. Enrolled patients with cryptogenic stroke were assigned to receive standard medical care or to undergo endovascular PFO closure, with a primary outcome of reduction in stroke recurrence rate. Secondary outcomes included rates of transient ischemic attack (TIA), composite outcome of stroke, TIA, and death from all causes, and rates of atrial fibrillation events. RESULTS: We analyzed data for 3412 patients. Transcatheter PFO closure resulted in a statistically significant reduced rate of recurrent stroke, compared with medication alone. Patients undergoing closure were 58% less likely to have another stroke. The number needed to treat with PFO closure to reduce recurrent stroke for 1 patient was 40. CONCLUSIONS: Endovascular PFO closure was associated with a reduced risk of recurrent stroke in patients with a prior cryptogenic cerebral infarct. Although the absolute stroke reduction was small, these findings are clinically significant, given the young age of this patient population and the patients' lifetime risk of recurrent stroke.