SummaryBackgroundIntensive antiplatelet therapy with three agents might be more effective than guideline treatment for preventing recurrent events in patients with acute cerebral ischaemia. We aimed to compare the safety and efficacy of intensive antiplatelet therapy (combined aspirin, clopidogrel, and dipyridamole) with that of guideline-based antiplatelet therapy.MethodsWe did an international, prospective, randomised, open-label, blinded-endpoint trial in adult participants with ischaemic stroke or transient ischaemic attack (TIA) within 48 h of onset. Participants were assigned in a 1:1 ratio using computer randomisation to receive loading doses and then 30 days of intensive antiplatelet therapy (combined aspirin 75 mg, clopidogrel 75 mg, and dipyridamole 200 mg twice daily) or guideline-based therapy (comprising either clopidogrel alone or combined aspirin and dipyridamole). Randomisation was stratified by country and index event, and minimised with prognostic baseline factors, medication use, time to randomisation, stroke-related factors, and thrombolysis. The ordinal primary outcome was the combined incidence and severity of any recurrent stroke (ischaemic or haemorrhagic; assessed using the modified Rankin Scale) or TIA within 90 days, as assessed by central telephone follow-up with masking to treatment assignment, and analysed by intention to treat. This trial is registered with the ISRCTN registry, number ISRCTN47823388.Findings3096 participants (1556 in the intensive antiplatelet therapy group, 1540 in the guideline antiplatelet therapy group) were recruited from 106 hospitals in four countries between April 7, 2009, and March 18, 2016. The trial was stopped early on the recommendation of the data monitoring committee. The incidence and severity of recurrent stroke or TIA did not differ between intensive and guideline therapy (93 [6%] participants vs 105 [7%]; adjusted common odds ratio [cOR] 0·90, 95% CI 0·67–1·20, p=0·47). By contrast, intensive antiplatelet therapy was associated with more, and more severe, bleeding (adjusted cOR 2·54, 95% CI 2·05–3·16, p<0·0001).InterpretationAmong patients with recent cerebral ischaemia, intensive antiplatelet therapy did not reduce the incidence and severity of recurrent stroke or TIA, but did significantly increase the risk of major bleeding. Triple antiplatelet therapy should not be used in routine clinical practice.FundingNational Institutes of Health Research Health Technology Assessment Programme, British Heart Foundation.

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IntroductionElderly patients are recognised to be at increased risk of oropharyngeal dysphagia (OPD), the causes of which are likely to be multifactorial.1,2 The study aim is to identify if sepsis is an additional risk factor for OPD in the elderly (age ≥ 65).MethodsA hospital electronic database was searched for all elderly patients (≥65 years) referred for assessment for suspected dysphagia between May 2013 and January 2014. Exclusion criteria were age < 65 years and/or concurrent OPD due to: acute intracranial event, space occupying lesion or trauma. Data were collected on age; sex; co-morbidities; delirium; existing OPD; body mass index (BMI) on admission + discharge; sepsis; type of sepsis; microbiology confirming sepsis; diagnosis of sepsis made before OPD; recovery of OPD with resolution of sepsis; mortality; aspiration subsequent to sepsis and OPD and medication potentially contributing to OPD (e.g. benzodiazepines and opiates). Sepsis was defined as evidence of a systemic inflammatory response syndrome with a clinical suspicion of infection.ResultsThree hundred of 1470 patients referred for dysphagia assessment during the study period met the inclusion criteria. The prevalence of sepsis induced OPD was 17% (50 patients). The mean age was 82 years while the median was 80. The interquartile age range was 12.5 years. 60% were male and 40% female. Admission BMIs ranged from 15.8 to 34.3 with a median of 21.2.Common co-morbidities included: dementia, chronic obstructive pulmonary disease, ischaemic heart disease, diabetes and chronic kidney disease. Within this group, the vast majority (76%) failed to recover swallowing, 14% had complications of aspiration and 36% died. Types of sepsis included: chest (48%); mixed (26%); urological (18%); biliary (4%); cellulitis (2%); intra-abdominal (2%); gastroenteritis (2%) and unknown (2%). Confirmatory microbiology was found in only 38%. Other factors contributing to the risk for dysphagia included delirium (18%) or new onset confusion (26%), reduced conscious level (26%) and intake of medication potentially contributing to OPD (38%). However 14% of patients had sepsis induced dysphagia without any clear or established risk factors.ConclusionThe prevalence of sepsis induced dysphagia is significant (17%) and should be taken into account in any new onset aspiration event in older hospitalised patients. Additional risk factors include neuroleptic medication, reduced conscious levels and associated confusion. Sepsis should be recognised as a major factor in the decompensation of swallowing and OPD in the elderly which rarely recovers, has increased mortality and might be considered a geriatric syndrome for which clinicians should be vigilant.References1 Shaw DW, Cook IJ, Gabb M, Holloway RH, Simula ME, et al. Influence of normal ageing on oral-pharyngeal and upper esophageal sphincter function during swallowing. Am J Physiol. 1995;268(3 Pt 1):G389–96.2 Rofes L, Arreola V, Almirall J, Cabre M, Campins L, Garcia-Peris P, et al. Diagnosis and management of oropharyngeal dyspha...

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