Harry Gibbs

Low-Dose Aspirin for Preventing Recurrent Venous Thromboembolism

BACKGROUND Patients who have had a first episode of unprovoked venous thromboembolism have a high risk of recurrence after anticoagulants are discontinued. Aspirin may be effective in preventing a recurrence of venous thromboembolism. METHODS We randomly assigned 822 patients who had completed initial anticoagulant therapy after a first episode of unprovoked venous thromboembolism to receive aspirin, at a dose of 100 mg daily, or placebo for up to 4 years. The primary outcome was a recurrence of venous thromboembolism. RESULTS During a median follow-up period of 37.2 months, venous thromboembolism recurred in 73 of 411 patients assigned to placebo and in 57 of 411 assigned to aspirin (a rate of 6.5% per year vs. 4.8% per year; hazard ratio with aspirin, 0.74; 95% confidence interval [CI], 0.52 to 1.05; P=0.09). Aspirin reduced the rate of the two prespecified secondary composite outcomes: the rate of venous thromboembolism, myocardial infarction, stroke, or cardiovascular death was reduced by 34% (a rate of 8.0% per year with placebo vs. 5.2% per year with aspirin; hazard ratio with aspirin, 0.66; 95% CI, 0.48 to 0.92; P=0.01), and the rate of venous thromboembolism, myocardial infarction, stroke, major bleeding, or death from any cause was reduced by 33% (hazard ratio, 0.67; 95% CI, 0.49 to 0.91; P=0.01). There was no significant between-group difference in the rates of major or clinically relevant nonmajor bleeding episodes (rate of 0.6% per year with placebo vs. 1.1% per year with aspirin, P=0.22) or serious adverse events. CONCLUSIONS In this study, aspirin, as compared with placebo, did not significantly reduce the rate of recurrence of venous thromboembolism but resulted in a significant reduction in the rate of major vascular events, with improved net clinical benefit. These results substantiate earlier evidence of a therapeutic benefit of aspirin when it is given to patients after initial anticoagulant therapy for a first episode of unprovoked venous thromboembolism. (Funded by National Health and Medical Research Council [Australia] and others; Australian New Zealand Clinical Trials Registry number, ACTRN12605000004662.).

Edoxaban for treatment of venous thromboembolism in patients with cancer: Rationale and design of the hokusai VTE-cancer study

Direct oral anticoagulants may be effective and safe for treatment of venous thromboembolism (VTE) in cancer patients, but they have not been compared with low-molecular-weight heparin (LMWH), the current recommended treatment for these patients. The Hokusai VTE-cancer study is a randomised, open-label, clinical trial to evaluate whether edoxaban, an oral factor Xa inhibitor, is non-inferior to LMWH for treatment of VTE in patients with cancer. We present the rationale and some design features of the study. One such feature is the composite primary outcome of recurrent VTE and major bleeding during a 12-month study period. These two complications occur frequently in cancer patients receiving anticoagulant treatment and have a significant impact. The evaluation beyond six months will fill the current gap in the evidence base for the long-term treatment of these patients. Based on the observation that the risk of recurrent VTE in patients with active cancer is similar to that in those with a history of cancer, the Hokusai VTE-cancer study will enrol patients if whose cancer was diagnosed within the past two years. In addition, patients with incidental VTE are eligible because their risk of recurrent VTE is similar to that in patients with symptomatic disease. The unique design features of the Hokusai VTE-cancer study should lead to enrolment of a broad spectrum of cancer patients with VTE who could benefit from oral anticoagulant treatment.

A home‐based progressive resistance exercise programme for patients with venous leg ulcers: a feasibility study

This study aimed to assess the feasibility of a home‐based exercise programme and examine the effects on the healing rates of venous leg ulcers. A 12‐week randomised controlled trial was conducted investigating the effects of an exercise intervention compared to a usual care group. Participants in both groups (n = 13) had active venous ulceration and were treated in a metropolitan hospital outpatients clinic in Australia. Data were collected on recruitment from medical records, clinical assessment and questionnaires. Follow‐up data on progress in healing and treatments were collected fortnightly for 12 weeks. Calf muscle pump function data were collected at baseline and 12 weeks from recruitment. Range of ankle motion data were collected at baseline, 6 and 12 weeks from recruitment. This pilot study indicated that the intervention was feasible. Clinical significance was observed in the intervention group with a 32% greater decrease in ulcer size (P = 0·34) than the usual care group, and a 10% (P = 0·74) improvement in the number of participants healed in the intervention group compared to the usual care group. Significant differences between groups over time were observed in calf muscle pump function parameters [ejection fraction (P = 0·05), residual volume fraction (P = 0·04)] and range of ankle motion (P = 0·01). This pilot study is one of the first to examine and measure clinical healing rates for participants involved in a home‐based progressive resistance exercise programme. Further research is warranted with a larger multi‐site study.

Antithrombotic treatment for stroke prevention in atrial fibrillation: The Asian agenda

Atrial fibrillation (AF) is the most common heart arrhythmia. Untreated AF incurs a considerable burden of stroke and associated healthcare costs. Asians have AF risk factors similar to Caucasians and a similarly increased risk of AF-related stroke; however, with a vast and rapidly ageing population, Asia bears a disproportionately large disease burden. Urgent action is warranted to avert this potential health crisis. Antithrombotic therapy with oral anticoagulants is the most effective means of preventing stroke in AF and is a particular priority in Asia given the increasing disease burden. However, AF in Asia remains undertreated. Conventional oral anticoagulation with warfarin is problematic in Asia due to suboptimal control and a propensity among Asians to warfarin-induced intracranial haemorrhage. Partly due to concerns about intracranial haemorrhage, there are considerable gaps between AF treatment guidelines and clinical practice in Asia, in particular overuse of antiplatelet agents and underuse of anticoagulants. Compared with warfarin, new direct thrombin inhibitors and Factor Xa inhibitors are non-inferior in preventing stroke and significantly reduce the risk of life-threatening bleeding, particularly intracranial bleeding. These agents may therefore provide an appropriate alternative to warfarin in Asian patients. There is considerable scope to improve stroke prevention in AF in Asia. Key priorities include: early detection of AF and identification of asymptomatic patients; assessment of stroke and bleeding risk for all AF patients; evidence-based pharmacotherapy with direct-acting oral anticoagulant agents or vitamin K antagonists for AF patients at risk of stroke; controlling hypertension; and awareness-raising, education and outreach among both physicians and patients.

Reducing medication errors in hospital discharge summaries: a randomised controlled trial.

Objectives: To evaluate whether pharmacists completing the medication management plan in the medical discharge summary reduced the rate of medication errors in these summaries.

Partnered pharmacist charting on admission in the General Medical and Emergency Short‐stay Unit – a cluster‐randomised controlled trial in patients with complex medication regimens

Patients admitted to general medical units and emergency short‐stay units are often complex with multiple comorbidities, polypharmacy and at risk for drug‐related problems associated with increased morbidity and mortality. The aim of this study was to evaluate the effectiveness of a partnered pharmacist charting model completed at the time of admission to prevent medication errors.

A feasibility study of the provision of a personalized interdisciplinary audiovisual summary to facilitate care transfer care at hospital discharge: Care Transfer Video (CareTV)

OBJECTIVE To assess the feasibility and patient acceptance of a personalized interdisciplinary audiovisual record to facilitate effective communication with patients, family, carers and other healthcare workers at hospital discharge. DESIGN Descriptive pilot study utilizing a study-specific patient feedback questionnaire conducted from October 2013 to June 2014. SETTING AND PARTICIPANTS Twenty General Medical inpatients being discharged from an Acute General Medical Ward in a metropolitan teaching hospital. INTERVENTION Audiovisual record of a CareTV filmed at the patients bedside by a consultant-led interdisciplinary team, within 24 h prior to discharge from the ward, provided immediately for the patient to take home. Patient surveys were completed within 2 weeks of discharge. MAIN OUTCOME MEASURES Technical quality, utilization, acceptability, patient satisfaction and recall of diagnosis, medication changes and post-discharge review arrangements. RESULTS All patients had watched their CareTV either alone or in the presence of a variety of others: close family, their GP, a medical specialist, friends or other health personnel. Participating patients had good understanding of the video content and recall of their diagnosis, medication changes and post-discharge plans. Patient feedback was overwhelmingly positive. CONCLUSIONS In the context of a General Medical Unit with extensive experience in interdisciplinary bedside rounding and teamwork, CareTV is simple to implement, inexpensive, technically feasible, requires minimal staff training and is acceptable to patients. The results of this pilot study will inform and indicate the feasibility of conducting a larger randomized control trial of the impact of CareTV on patient satisfaction, medication adherence and recall of key information, and primary healthcare provider satisfaction.

Combining anticoagulation and antiplatelet drugs in coronary artery disease

Balancing the risk of thrombosis and bleeding after acute coronary syndrome can be difficult. Is triple therapy better than dual therapy?

Corticosteroid therapy for pneumonia

www.thelancet.com Vol 386 September 5, 2015 953 investigators did not discuss the low rate of recruitment (in 4·5 years and seven tertiary hospitals only 802 [27%] of 2911 identifi ed patients were recruited). In particular, the characteristics of the 605 (21%) eligible patients who declined to participate were not provided, raising the question of whether their refusal might have been associated with severity of disease. Although almost 50% of participants’ disease was of pneumonia severity index (PSI) class IV–V, the median and interquartile range of participants’ vital signs were close to or at clinically normal values, which suggests minimal physiological disturbance. Other severity indices, such as SMARTCOP, have been shown to out-perform the PSI score in predicting which patients will require intensive respiratory and vasopressor support in intensive care units. Patients with CAP who would benefi t most from corticosteroid therapy would presumably be patients demonstrating the most severe local and systemic inflammatory response and requiring physiological support. We urge caution in translating the results of this study into clinical practice until further well-structured randomised controlled trials can identify a group of high-risk CAP patients who would be most likely to benefit from the corticosteroid treatment.