stroke; secondary prevention; percutaneous device closure; patent foramen ovale; medical treatment; cryptogenic stroke
Wahl A, Juni P, Mono ML, Kalesan B, Praz F, Geister L, Raber L, Nedeltchev K, Mattle HP, Windecker S, Meier B (2012), Long-Term Propensity Score-Matched Comparison of Percutaneous Closure of Patent Foramen Ovale With Medical Treatment After Paradoxical Embolism, in CIRCULATION
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Mono ML, Geister L, Galimanis A, Jung S, Praz F, Arnold M, Fischer U, Wolff S, Findling O, Windecker S, Wahl A, Meier B, Mattle HP, Nedeltchev K (2011), Patent Foramen Ovale May Be Causal for the First Stroke but Unrelated to Subsequent Ischemic Events, in STROKE
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Background: The prevalence of patent foramen ovale (PFO) is about 25% in the general population and approximately 40% in patients who have ischemic stroke of unknown cause (cryptogenic stroke). Given the large number of asymptomatic patients, no primary prevention is currently recommended. On the contrary, secondary prevention is very important. Prospective studies have shown that antithrombotic treatment (ATT) with aspirin or warfarin appears to negate the risk of recurrent stroke associated with a PFO. Patients with spontaneous or large right-to-left shunts (RLS), those with a coinciding atrial septal aneurysm (ASA) or multiple ischemic events prior to the PFO diagnosis may still be at increased risk of stroke recurrence despite ATT. Percutaneous device closure (PDC) is a challenging alternative to ATT. Several studies reported 0% to 3.4% annual recurrence rates of stroke or TIA in patients treated by PDC. To date, there is no data from randomized controlled trials (RCT) comparing the risk of stroke recurrence after PDC with that under ATT only. The results from ongoing RCTs are not to be awaited in the near future, mainly due to low enrolment and event rates. Even if RCTs are completed successfully, statistical differences may remain undetected with the planned sample sizes. Alternative data-gathering strategies such as multicenter registries are needed to overcome the low recruitment rates. Aims: 1) To compare the risk of recurrent stroke and TIA in patients aged = 55 years with PFO and otherwise unexplained stroke who undergo PDC or receive ATT only; 2) To assess the etiological role of PFO for stroke/TIA in patients aged > 55 years; 3) To assess the risk of recurrent stroke/TIA in “high-risk” PFO patients (i.e. those with spontaneous (at rest) or large RLS, coinciding ASA, or multiple previous cerebrovascular events).Methodology: Multicenter prospective non-randomized study with scheduled 3-years follow-up of patients with PFO and ischemic stroke or TIA. Participating centers: University hospitals of Basel, Bern, Geneva, Lausanne, and Zurich, and the Cantonal Hospitals of Aarau and St. Gallen.Potential significance:1) The study will assess the current management of patients with PFO and stroke or TIA. There will be no age limits and no restrictions to the type of device used for PFO closure. 2) The proposal reflects the joint commitment of neurologists and cardiologists from 5 university and 2 cantonal hospitals in Switzerland. The study is potentially extendable to other hospitals in Switzerland and abroad (There is an ongoing collaboration with Prof. K. Niederkorn and Prof. S. Horner from the University of Graz, Austria). 3) A sample size of 1’500 patients will allow us to detect even small differences (2% ARR, a = 0.95; power 90%) in the rates of stroke and TIA recurrence between PDC and medical treatment only. Subgroup analyses of “high-risk” patients will also be possible.