International journal of stroke : official journal of the International Stroke Society
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Decompressive hemicraniectomy for malignant middle cerebral artery infarction has long been controversial. Recently, data from randomised-controlled trials have shown that the procedure is life-saving and improves outcome. However, these randomised-controlled trials were difficult to conduct, because of ethical considerations due to high mortality in control groups. While the use of historical comparators may not be ideal for phase III efficacy trials, these data may be useful to inform the selection of trial populations. We sought to replicate the findings of the DESTINY trial of decompressive surgery in malignant middle cerebral artery infarction using the Virtual International Stroke Trials Archive, to determine whether historical comparators could be used as an alternative to control groups in situations where randomised-controlled trials are infeasible or regarded as unethical due to the high mortality under conservative treatment. ⋯ The beneficial effects of decompressive hemicraniectomy on survival were not confirmed using a historical comparator dataset. Our observations might be due to the fact that patients with malignant middle cerebral artery infarction are usually excluded from clinical trials of drug efficacy, and patients identified from Virtual International Stroke Trials Archive may not have been truly representative of patients with malignant middle cerebral artery infarction. This mismatch could be rectified through recruitment of population-based studies and stroke registries to Virtual International Stroke Trials Archive to increase the number of patients eligible for entry into the comparator patient data pool.
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The occurrence of atrial fibrillation after percutaneous closure of a patent foramen ovale for cryptogenic stroke has been reported in a variable percentage of patients. However, its precise incidence and mechanism are presently unclear and remain to be elucidated. ⋯ Our findings indicate that patients with cryptogenic stroke and patent foramen ovale have a rather high incidence of AF during a follow-up of 12 months. Atrial fibrillation occurred with a similar frequency whether the patent foramen ovale/atrial septal defect was successfully percutaneously closed or was medically managed. The presence of a large patent foramen ovale was the only significant predictor of AF occurrence during follow-up.