SummaryBackgroundStents are an alternative treatment to carotid endarterectomy for symptomatic carotid stenosis, but previous trials have not established equivalent safety and efficacy. We compared the safety of carotid artery stenting with that of carotid endarterectomy.MethodsThe International Carotid Stenting Study (ICSS) is a multicentre, international, randomised controlled trial with blinded adjudication of outcomes. Patients with recently symptomatic carotid artery stenosis were randomly assigned in a 1:1 ratio to receive carotid artery stenting or carotid endarterectomy. Randomisation was by telephone call or fax to a central computerised service and was stratified by centre with minimisation for sex, age, contralateral occlusion, and side of the randomised artery. Patients and investigators were not masked to treatment assignment. Patients were followed up by independent clinicians not directly involved in delivering the randomised treatment. The primary outcome measure of the trial is the 3-year rate of fatal or disabling stroke in any territory, which has not been analysed yet. The main outcome measure for the interim safety analysis was the 120-day rate of stroke, death, or procedural myocardial infarction. Analysis was by intention to treat (ITT). This study is registered, number ISRCTN25337470.FindingsThe trial enrolled 1713 patients (stenting group, n=855; endarterectomy group, n=858). Two patients in the stenting group and one in the endarterectomy group withdrew immediately after randomisation, and were not included in the ITT analysis. Between randomisation and 120 days, there were 34 (Kaplan-Meier estimate 4·0%) events of disabling stroke or death in the stenting group compared with 27 (3·2%) events in the endarterectomy group (hazard ratio [HR] 1·28, 95% CI 0·77–2·11). The incidence of stroke, death, or procedural myocardial infarction was 8·5% in the stenting group compared with 5·2% in the endarterectomy group (72 vs 44 events; HR 1·69, 1·16–2·45, p=0·006). Risks of any stroke (65 vs 35 events; HR 1·92, 1·27–2·89) and all-cause death (19 vs seven events; HR 2·76, 1·16–6·56) were higher in the stenting group than in the endarterectomy group. Three procedural myocardial infarctions were recorded in the stenting group, all of which were fatal, compared with four, all non-fatal, in the endarterectomy group. There was one event of cranial nerve palsy in the stenting group compared with 45 in the endarterectomy group. There were also fewer haematomas of any severity in the stenting group than in the endarterectomy group (31 vs 50 events; p=0·0197).InterpretationCompletion of long-term follow-up is needed to establish the efficacy of carotid artery stenting compared with endarterectomy. In the meantime, carotid endarterectomy should remain the treatment of choice for patients suitable for surgery.FundingMedical Research Council, the Stroke Association, Sanofi-Synthélabo, European Union.

OBJECTIVETo determine the microbiological profile of diabetes-related foot infections (DRFIs) and the impact of wound duration, inpatient treatment, and chronic kidney disease (CKD).RESEARCH DESIGN AND METHODSPostdebridement microbiological samples were collected from individuals presenting with DRFIs from 1 January 2005 to 31 December 2007.RESULTSA total of 653 specimens were collected from 379 individuals with 36% identifying only one isolate. Of the total isolates, 77% were gram-positive bacteria (staphylococci 43%, streptococci 13%). Methicillin-resistant Staphylococcus aureus (MRSA) was isolated from 23%; risk factors for MRSA included prolonged wound duration (odds ratio 2.31), inpatient management (2.19), and CKD (OR 1.49). Gram-negative infections were more prevalent with inpatient management (P = 0.002) and prolonged wound duration (P < 0.001). Pseudomonal isolates were more common in chronic wounds (P < 0.001).CONCLUSIONSDRFIs are predominantly due to gram-positive aerobes but are usually polymicrobial and increase in complexity with inpatient care and ulcer duration. In the presence of prolonged duration, inpatient management, or CKD, empiric MRSA antibiotic cover should be considered.

Trauma, in the form of pressure and/or friction from footwear, is a common cause of foot ulceration in people with diabetes. These practical recommendations regarding the provision of footwear for people with diabetes were agreed upon following review of existing position statements and clinical guidelines. The aim of this process was not to re-invent existing guidelines but to provide practical guidance for health professionals on how they can best deliver these recommendations within the Australian health system. Where information was lacking or inconsistent, a consensus was reached following discussion by all authors. Appropriately prescribed footwear, used alone or in conjunction with custom-made foot orthoses, can reduce pedal pressures and reduce the risk of foot ulceration. It is important for all health professionals involved in the care of people with diabetes to both assess and make recommendations on the footwear needs of their clients or to refer to health professionals with such skills and knowledge. Individuals with more complex footwear needs (for example those who require custom-made medical grade footwear and orthoses) should be referred to health professionals with experience in the prescription of these modalities and who are able to provide appropriate and timely follow-up. Where financial disadvantage is a barrier to individuals acquiring appropriate footwear, health care professionals should be aware of state and territory based equipment funding schemes that can provide financial assistance. Aboriginal and Torres Strait Islanders and people living in rural and remote areas are likely to have limited access to a broad range of footwear. Provision of appropriate footwear to people with diabetes in these communities needs be addressed as part of a comprehensive national strategy to reduce the burden of diabetes and its complications on the health system.

ata from the Australian Institute of Health and Welfare (AIHW) suggest that one Australian loses a lower limb every 3 hours as a direct result of diabetes-related foot disease (DRFD). 1 Further data suggest there has been a 30% increase in diabetes-related amputations in Australia over the past decade, with 8% of diabetes-related deaths being attributable to foot disease. 1,2 These statistics are especially disappointing given the exponential growth in knowledge, research and published guidelines on managing DRFD. 3,4 In order to reduce this significant burden, several complementary measures are therefore urgently required.To allow for long-term surveillance of DRFD in Australia, it is paramount that data collection is initiated at a national level. The health system does not currently allow for collection of information from both public and private sectors, and ignores the large group of people managed solely in the community. Effective allocation of resources and care coordination are likely to be hindered by this lack of data, as are identification of at-risk patient groups and development and evaluation of preventive strategies. Solutions for improving data collection would include creation of specific Medicare item numbers for DRFD and development of web-based data collection forms and databases.The inclusion of chronic disease management items in the Medicare Benefits Schedule (MBS) is acknowledged as a step forward in the fight against DRFD. Reports suggest that 1.3 million consultations were provided by podiatrists under this program in 2004-2008, accounting for 34% of all consultations. 5 It is important to note, however, that this funding arrangement does not allow for more frequent follow-up for individuals with acute DRFD complications or needing intensive secondary prevention due to previous ulceration and/or amputation. Recurrence rates for foot ulceration range from 20%-80% annually, with many of these ulcers leading to amputation. 6 Improved access to publicly funded specialised foot care services, and increasing the number of rebates available under the MBS, are seen as cost-effective necessities for people with current or past foot complications. The cost of this would be recouped by preventing future hospitalisations and amputations.Improved access to appropriately skilled health care providers and multidisciplinary teams is required, and could be achieved if Australian health care policymakers adopt a standardised national model of care for DRFD. This model must sustain a continuum of care between community-based health care and local hospitals. Research supports the resourcing and implementation of well defined treatment pathways provided under a multidisciplinary model of care. 7,8 A standardised national service model would also support a national network of interdisciplinary DRFD clinics, in turn facilitating the development of a national database to assist with referral pathways, data collection, initiation of quality improvement programs and benchmarking across organisations. Such a mod...

Appropriate assessment and management of diabetes-related foot ulcers (DRFUs) is essential to reduce amputation risk. Management requires debridement, wound dressing, pressure off-loading, good glycaemic control and potentially antibiotic therapy and vascular intervention. As a minimum, all DRFUs should be managed by a doctor and a podiatrist and/or wound care nurse. Health professionals unable to provide appropriate care for people with DRFUs should promptly refer individuals to professionals with the requisite knowledge and skills. Indicators for immediate referral to an emergency department or multidisciplinary foot care team (MFCT) include gangrene, limb-threatening ischaemia, deep ulcers (bone, joint or tendon in the wound base), ascending cellulitis, systemic symptoms of infection and abscesses. Referral to an MFCT should occur if there is lack of wound progress after 4 weeks of appropriate treatment.

This is the first study which demonstrates that second toe systolic pressures are interchangeable with those of the first toe. Second toe pressures can be used in diabetic patients whose first toe pressures cannot be assessed.

Background Frailty predicts adverse perioperative outcomes and increased mortality in patients having vascular surgery. Frailty assessment is a potential tool to inform resource allocation, and shared decision‐making about vascular surgery in the resource constrained COVID‐19 pandemic environment. This cohort study describes the prevalence of frailty in patients having vascular surgery and the association between frailty, mortality and perioperative outcomes. Methods The COVID‐19 Vascular Service in Australia (COVER‐AU) prospective cohort study evaluates 30‐day and six‐month outcomes for consecutive patients having vascular surgery in 11 Australian vascular units, March–July 2020. The primary outcome was mortality, with secondary outcomes procedure‐related outcomes and hospital utilization. Frailty was assessed using the nine‐point visual Clinical Frailty Score, scores of 5 or more considered frail. Results Of the 917 patients enrolled, 203 were frail (22.1%). The 30 day and 6 month mortality was 2.0% ( n = 20) and 5.9% ( n = 35) respectively with no significant difference between frail and non‐frail patients (OR 1.68, 95%CI 0.79–3.54). However, frail patients stayed longer in hospital, had more perioperative complications, and were more likely to be readmitted or have a reoperation when compared to non‐frail patients. At 6 months, frail patients had twice the odds of major amputation compared to non‐frail patients, after adjustment (OR 2.01; 95% CI 1.17–3.78), driven by a high rate of amputation during the period of reduced surgical activity. Conclusion Our findings highlight that older, frail patients, experience potentially preventable adverse outcomes and there is a need for targeted interventions to optimize care, especially in times of healthcare stress.

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