Risk of Venous Thromboembolism in Patients Nursed at Home or in Long-Term Care Residential Facilities

Background. This study investigated the prevalence of and impact of risk factors for deep venous thrombosis (DVT) in patients with chronic diseases, bedridden or with greatly limited mobility, cared for at home or in long-term residential facilities. Methods. We enrolled 221 chronically ill patients, all over 18 years old, markedly or totally immobile, at home or in long-term care facilities. They were screened at the bedside by simplified compression ultrasound. Results. The prevalence of asymptomatic proximal DVT was 18% (95% CI 13–24%); there were no cases of symptomatic DVT or pulmonary embolism. The best model with at most four risk factors included: previous VTE, time of onset of reduced mobility, long-term residential care as opposed to home care and causes of reduced mobility. The risk of DVT for patients with reduced mobility due to cognitive impairment was about half that of patients with cognitive impairment/dementia. Conclusions. This is a first estimate of the prevalence of DVT among bedridden or low-mobility patients. Some of the risk factors that came to light, such as home care as opposed to long-term residential care and cognitive deficit as causes of reduced mobility, are not among those usually observed in acutely ill patients

Patterns of treatment with antiplatelet therapy after an acute coronary syndrome: Data from a large database in a community setting

Aims Current guidelines strongly recommend antiplatelet therapy with aspirin plus a P2Y12 receptor inhibitor (dual therapy) for patients with acute coronary syndrome (ACS). To better understand how antiplatelet treatment is prescribed in clinical practice, the aim of this study was to provide a more detailed description of real-world patients with and without antiplatelet treatment after an ACS, their outcomes at one-year follow-up and the related integrated cost. Methods The ReS database, including more than 12 million inhabitants, was evaluated. During the accrual period ACS patients discharged alive were identified on the basis of ICD-IX-CM code. Antiplatelet drug prescriptions and healthcare costs were analysed over one-year follow-up. Results In 2014, of the 25,129 patients discharged alive after an ACS, 5796 (23%) did not receive any antiplatelet therapy during the first month after hospital discharge. Among them, 3846 (66%) subjects were prescribed an antiplatelet drug subsequently, while 7.7% did not receive any antiplatelet treatment during the whole following year. Dual therapy in the subgroup of patients undergoing a revascularization procedure ( n = 8436) was prescribed to 79.2% of cases and to 46.1% ( n = 4009) of medically managed patients. The patients not treated with an antiplatelet treatment in the first month showed the highest one-year healthcare costs, mostly due to hospital re-admissions. Conclusions This analysis of a large patient community shows that a considerable proportion of patients remained untreated with antiplatelet treatment after an ACS event. A clearer characterization of these subjects can help to improve the adherence to the current guidelines and recommendations

Effectiveness of a Hospital-Based Computerized Decision Support System on Clinician Recommendations and Patient Outcomes: A Randomized Clinical Trial.

IMPORTANCE: Sophisticated evidence-based information resources can filter medical evidence from the literature, integrate it into electronic health records, and generate recommendations tailored to individual patients. OBJECTIVE: To assess the effectiveness of a computerized clinical decision support system (CDSS) that preappraises evidence and provides health professionals with actionable, patient-specific recommendations at the point of care. DESIGN, SETTING, AND PARTICIPANTS: Open-label, parallel-group, randomized clinical trial among internal medicine wards of a large Italian general hospital. All analyses in this randomized clinical trial followed the intent-to-treat principle. Between November 1, 2015, and December 31, 2016, patients were randomly assigned to the intervention group, in which CDSS-generated reminders were displayed to physicians, or to the control group, in which reminders were generated but not shown. Data were analyzed between February 1 and July 31, 2018. INTERVENTIONS: Evidence-Based Medicine Electronic Decision Support (EBMEDS), a commercial CDSS covering a wide array of health conditions across specialties, was integrated into the hospital electronic health records to generate patient-specific recommendations. MAIN OUTCOMES AND MEASURES: The primary outcome was the resolution rate, the rate at which medical problems identified and alerted by the CDSS were addressed by a change in practice. Secondary outcomes included the length of hospital stay and in-hospital all-cause mortality. RESULTS: In this randomized clinical trial, 20 563 patients were admitted to the hospital. Of these, 6480 (31.5%) were admitted to the internal medicine wards (study population) and randomized (3242 to CDSS and 3238 to control). The mean (SD) age of patients was 70.5 (17.3) years, and 54.5% were men. In total, 28 394 reminders were generated throughout the course of the trial (median, 3 reminders per patient per hospital stay; interquartile range [IQR], 1-6). These messages led to a change in practice in approximately 4 of 100 patients. The resolution rate was 38.0% (95% CI, 37.2%-38.8%) in the intervention group and 33.7% (95% CI, 32.9%-34.4%) in the control group, corresponding to an odds ratio of 1.21 (95% CI, 1.11-1.32; P < .001). The length of hospital stay did not differ between the groups, with a median time of 8 days (IQR, 5-13 days) for the intervention group and a median time of 8 days (IQR, 5-14 days) for the control group (P = .36). In-hospital all-cause mortality also did not differ between groups (odds ratio, 0.95; 95% CI, 0.77-1.17; P = .59). Alert fatigue did not differ between early and late study periods. CONCLUSIONS AND RELEVANCE: An international commercial CDSS intervention marginally influenced routine practice in a general hospital, although the change did not statistically significantly affect patient outcomes. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT02577198

Prevalence of peripheral arterial disease in subjects with moderate cardiovascular risk: Italian results from the PANDORA study Data from PANDORA (Prevalence of peripheral Arterial disease in subjects with moderate CVD risk, with No overt vascular Diseases nor Diabetes mellitus)

<p>Abstract</p> <p>Background</p> <p>The PANDORA study has recently examined the prevalence of low ankle brachial index (ABI) in subjects with moderate risk of cardiovascular disease. This sub-analysis of the PANDORA study examines the prevalence of asymptomatic peripheral arterial disease (PAD), as determined by ABI, in Italian subjects presenting with moderate cardiovascular risk, in the absence of diabetes or overt vascular disease.</p> <p>Methods</p> <p>PANDORA is a non-interventional, cross-sectional study that was performed in 6 European countries, involving subjects with at least one cardiovascular (CV) risk factor. The primary objective was to evaluate the prevalence of asymptomatic PAD using ABI. For this post-hoc sub-analysis, data were extracted for subjects enrolled in Italy, comprising 51.5% (n = 5298) of subjects from the original PANDORA study. Secondary objectives were to establish the prevalence and treatment of CV risk factors.</p> <p>Results</p> <p>The mean age was 63.9 years and 22.9% (95% CI 21.7-24.0) of subjects presented with asymptomatic PAD. A range of risk factors comprising smoking, hypertension, low HDL-cholesterol, family history of coronary heart disease and habit of moderate-high alcohol intake were significantly associated with asymptomatic PAD (p < 0.0001). Statin treatment had the lowest incidence in Italian subjects. Furthermore, patients treated with statins were significantly less likely to have asymptomatic PAD than those who were not (p = 0.0001).</p> <p>Conclusions</p> <p>Asymptomatic PAD was highly prevalent in Italian subjects, the majority of whom were not candidates for ABI assessment according to current guidelines. Findings from this study suggest that these patients should be carefully examined in clinical practice and ABI measured so that therapeutic interventions known to decrease their CV risk may be offered.</p> <p>Trial registration number</p> <p>ClinicalTrials.gov: <a href="http://www.clinicaltrials.gov/ct2/show/NCT00689377">NCT00689377</a></p

Prevalence of peripheral arterial disease in patients at non-high cardiovascular risk. Rationale and design of the PANDORA study

<p>Abstract</p> <p>Background</p> <p>Lower extremity peripheral arterial disease (PAD) is a marker of widespread atherosclerosis. Individuals with PAD, most of whom do not show typical PAD symptoms ('asymptomatic' patients), are at increased risk of cardiovascular ischaemic events. American College of Cardiology/American Heart Association guidelines recommend that individuals with asymptomatic lower extremity PAD should be identified by measurement of ankle-brachial index (ABI). However, despite its associated risk, PAD remains under-recognised by clinicians and the general population and office-based ABI detection is still poorly-known and under-used in clinical practice. The Prevalence of peripheral Arterial disease in patients with a non-high cardiovascular disease risk, with No overt vascular Diseases nOR diAbetes mellitus (PANDORA) study has a primary aim of assessing the prevalence of lower extremity PAD through ABI measurement, in patients at non-high cardiovascular risk, with no overt cardiovascular diseases (including symptomatic PAD), or diabetes mellitus. Secondary objectives include documenting the prevalence and treatment of cardiovascular risk factors and the characteristics of both patients and physicians as possible determinants for PAD under-diagnosis.</p> <p>Methods/Design</p> <p>PANDORA is a non-interventional, cross-sectional, pan-European study. It includes approximately 1,000 primary care participating sites, across six European countries (Belgium, France, Greece, Italy, The Netherlands, Switzerland). Investigator and patient questionnaires will be used to collect both right and left ABI values at rest, presence of cardiovascular disease risk factors, current pharmacological treatment, and determinants for PAD under-diagnosis.</p> <p>Discussion</p> <p>The PANDORA study will provide important data to estimate the prevalence of asymptomatic PAD in a population otherwise classified at low or intermediate risk on the basis of current risk scores in a primary care setting.</p> <p>Trial registration number</p> <p>Clinical Trials.gov Identifier: NCT00689377.</p

I nuovi farmaci ipolipemizzanti: focus sugli anticorpi monoclonali

The need for new lipid-lowering drugs is based on the clear-cut evidence that a considerable proportion of patients with dyslipidemia cannot reach the target of cardiovascular protection with the use of currently available drugs (statins, ezetimibe, fibrates). Among the new classes of drugs, proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors (namely alirocumab and evolocumab) provide an effective solution for patients with familial hypercholesterolemia as well as for high-risk patients who do not achieve the target or complain statin-related adverse events. The use of PCSK9 inhibitors is associated with a huge reduction in LDL-cholesterol levels (up to 30-40 mg/dl) with 1-2 monthly administrations, and their effect is integrated with that of statins and ezetimibe. The improvement of lipid profile is in the range of that observed with other new drugs such as lopitamide and mipomersen, while the tolerability profile appears definitely better. A more effective characterization of patients with dyslipidemia is the trainer of new research in the field of lipid-lowering drugs and PCSK9 inhibitors appear the more reliable product of such a promising research

Hypercholesterolemia and cardiovascular risk: advantages and limitations of current treatment options

Cardiovascular disease is the leading cause of premature death in Europe. High blood cholesterol is one of the major cardiovascular risk factors and plays a crucial role in causing cardiovascular disease. A strong positive and linear association between total and LDL cholesterol levels and the risk of cardiovascular events has been widely documented. Every 1.0 mmol/l decrease in LDL cholesterol levels results in a significant reduction in cardiovascular mortality and in the risk of nonfatal myocardial infarction. Lipid-lowering guidelines suggest as first step the use of statins as monotherapy and, in case of failure to achieve the recommended targets, combination therapy of statins with other cholesterol-lowering drugs such as ezetimibe. The results from the recent IMPROVE-IT trial provide evidence that further LDL-cholesterol lowering beyond the recommended targets significantly reduces the rate of cardiovascular events, supporting the concept that "Lower Is Better" while additional long-term data are collected. Non-adherence to statin therapy, often due to adverse drug reactions, results in an increased risk for cardiovascular events. In a non-negligible proportion of patients with hypercholesterolemia receiving maximally tolerated statin therapy, the residual risk remains high. In addition, statin use has been associated with accelerated onset of diabetes in individuals already predisposed to developing diabetes. In conclusion, it is clear that statins are not the universal solution to the problem of high cholesterol levels, and the optimization of lipid-lowering therapy remains a therapeutic challenge

The introduction of biosimilars of low molecular weight heparins in Europe: a critical review and reappraisal endorsed by the Italian Society for Haemostasis and Thrombosis (SISET) and the Italian Society for Angiology and Vascular Medicine (SIAPAV)

Abstract Recently, the European Medicines Agency (EMA) authorized the introduction and marketing of Thorinane® and Inhixa®, biosimilars of the Low Molecular Weight Heparin (LMWH) enoxaparin. The authorization path is considerably different from the guidelines published by the EMA in 2009, as well as from the recommendations from the International Society on Thrombosis and Haemostasis published in 2013. Indeed, both of them recommended that LMWHs biosimilars therapeutic equivalence should be demonstrated in at least one adequately designed clinical trial. Shortly after enoxaparin biosimilars approval, EMA published a revised version of its guideline, no longer requiring the execution of a clinical study in patients at risk of venous thromboembolism. Also the assessment of safety shows some relevant flaws, as it relies only on a 20 healthy volunteers study, clearly underpowered to draw any conclusions about the safety profile of the drug. In our opinion, the approach taken by EMA for approval of enoxaparin biosimilars raises serious concerns about their actual, clinical “similarity”. On these grounds, with the endorsement of the Italian Society for Haemostasis and Thrombosis (SISET) and the Italian Society for Angiology and Vascular Medicine (SIAPAV), we elaborated the present document aimed at reviewing and reappraising some critical points regarding the introduction of biosimilars of LMWH in Europe. Moreover, we would strongly advise the Italian National Health Authorities not to entrust safety assessment to the post-marketing surveillance only, but to promote well designed and powered studies aimed at establish the actual efficacy and safety of LMWH biosimilars

Atherothrombotic Burden and Medium-Term Prognosis in Patients with Acute Ischemic Stroke: Findings of the SIRIO Study

Background: Short-and medium-term mortality after acute stroke is related to the severity of the index event and the patient's age. However, recent studies have reassessed the prognostic value of the systemic atherothrombotic burden in these patients, not only in the long term. This post hoc analysis of the findings of the SIRIO trial (Stroke in Italy and Related Impact on Outcome) examined the prognostic impact of systemic atherothrombosis. Methods: SIRIO was a multicenter observational study enrolling patients during the acute phase of stroke of both ischemic and hemorrhagic origin. The present analysis, however, only covered patients with ischemic stroke. At baseline, the main personal and clinical details were recorded and patients were classified as having either polyvascular disease or single arterial disease on the basis of whether they had symptomatic atherothrombotic disease in other sites besides the cerebrovascular location. For all patients we calculated the Essen Stroke Risk Score (ESRS), dividing them into groups with scores of less than 3 or 3 and more. We recorded total mortality and non-fatal vascular events 12 months after enrolment. Multivariate logistic regression analysis was used to select predictors of medium-term mortality and nonfatal cardiovascular events. There were 2,561 patients with ischemic stroke, 823 of them classified as having polyvascular disease; 940 (out of 2,485) had an ESRS of less than 3 and 1,545 had a score of 3 or more. Results: The combined endpoint 'death (all causes) and nonfatal cardiovascular events within 12 months of hospital discharge' was significantly dependent on the following factors: ESRS, Rankin scale and National Institutes of Health Stroke Scale scores, and polyvascular disease. Polyvascular disease status significantly affected mortality and nonfatal cardio- and cerebrovascular events after discharge (OR = 1.44, 95% CI = 1.10-1.88). Age was also confirmed as a significant predictor of the combined endpoint. Conclusions: Besides age and the clinical severity of the index event, symptomatic involvement of several vascular districts was also an important predictor of mortality and nonfatal cardiovascular events in the medium term in patients with ischemic stroke. Copyright (C) 2012 S. Karger AG, Base