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Patients with peripheral artery disease who underwent revascularization were randomly assigned to receive rivaroxaban (2.5 mg twice daily) or placebo. All patients received aspirin. The primary outcome of acute limb ischemia, major amputation for vascular causes, MI, ischemic stroke, or cardiovascular death occurred less frequently with rivaroxaban.

In a randomized trial, oral apixaban was noninferior to a low-molecular-weight heparin, dalteparin, in preventing recurrent venous thromboembolism at 6 months in patients with cancer. The use of apixaban was not associated with a higher risk of major bleeding than dalteparin, even in patients with gastrointestinal cancer.

Background. Atherothrombotic disease, including coronary artery disease (CAD) and peripheral artery disease (PAD), can lead to cardiovascular (CV) events, such as myocardial infarction, stroke, limb ischemia, heart failure, and CV death. Aim. Evaluate the humanistic and economic burden of CAD and PAD and identify unmet needs through a comprehensive literature review. Methods. Relevant search terms were applied across online publication databases. Studies published between January 2010 and August 2017 meeting the inclusion/exclusion criteria were selected; guidelines were also included. Two rounds of screening were applied to select studies of relevance. Results. Worldwide data showed approximately 5–8% prevalence of CAD and 10–20% prevalence of PAD, dependent on the study design, average age, gender, and geographical location. Data from the REACH registry indicated that 18–35% of patients with CAD and 46–68% of patients with PAD had disease in one or more vascular beds. Use of medication to control modifiable CV risk factors was variable by country (lower in France than in Canada); statins and aspirin were the most widely used therapies in patients with chronic disease. Survival rates have improved with medical advancements, but there is an additional need to improve the humanistic burden of disease (i.e., associated disability and quality of life). The economic burden of atherothrombotic disease is high and expected to increase with increased survival and the aging population. Conclusion. CAD and PAD represent a substantial humanistic and economic burden worldwide, highlighting a need for new interventions to reduce the incidence of atherothrombotic disease.

Superficial thrombophlebitis in the leg is associated with an increased risk of subsequent thromboembolic events; however, intervention to alter the risk has not been well studied. This study compared fondaparinux with placebo for patients with superficial thrombophlebitis in the leg. Superficial-vein thrombosis of the legs is a common condition, 1 , 2 with an estimated incidence that may exceed that of deep-vein thrombosis. 3 , 4 Patients with isolated superficial-vein thrombosis — that is, without concomitant deep-vein thrombosis or symptomatic pulmonary embolism at presentation — are at risk for subsequent symptomatic venous thromboembolic complications. 1 – 7 In a large, prospective, observational study, the 3-month risk of such complications was 8.3%, with a 3.3% risk of deep-vein thrombosis or pulmonary embolism. 8 The treatment of this disease has not been adequately addressed in randomized trials. Accordingly, the recommendations in various guidelines are weak, and in practice, therapeutic . . .

(1) Background: Danaparoid sodium is a heparinoid antithrombotic that has been used for over 40 years for prophylaxis of DVT in non-HIT patients and for the treatment of heparin-induced thrombocytopenia (HIT) with and without thrombosis. This update summarises current information on its pharmacology and reviews danaparoid dose management in a broad spectrum of clinical situations, including off-label indications. (2) Methods: Evidence from published clinical studies, case reports, compassionate use of danaparoid, and spontaneously reported serious adverse events is summarised and analysed by an interdisciplinary expert group to develop a consensus on dosing regimens of danaparoid for complex clinical situations, including vulnerable patient populations. (3) Results: Dosing regimens are proposed, together with monitoring recommendations and target anti-factor Xa ranges. (4) Conclusion: In a comprehensive summary detailed interdisciplinary dosing recommendations are described to provide a basis for safe and effective use of danaparoid.

Objectives Since the introduction of non-vitamin K antagonist (VKA) oral anticoagulants (NOACs), an additional treatment option, apart from VKAs, has become available for stroke prevention in patients with atrial fibrillation (AF). For various reasons, it is important to consider patients’ preferences regarding type of medication, particularly in view of the established relationship between preferences towards treatment, associated burden of treatment, and treatment adherence. This review aimed to systematically analyse the scientific literature assessing the preferences of AF patients with regard to long-term oral anticoagulant (OAC) treatment. Methods We searched the MEDLINE, Scopus and EMBASE databases (from 1980 to 2015), added records from reference lists of publications found, and conducted a systematic review based on all identified publications. Outcomes of interest included any quantitative information regarding the opinions or preferences of AF patients towards OAC treatment, ideally specified according to different clinical or convenience attributes describing different OAC treatment options. Results Overall, 27 publications describing the results of studies conducted in 12 different countries were included in our review. Among these, 16 studies analysed patient preferences towards OACs in general. These studies predominantly assessed which benefits (mainly lower stroke risk) AF patients would require to tolerate harms (mainly higher bleeding risk) associated with an OAC. Most studies showed that patients were willing to accept higher bleeding risks if a certain threshold in stroke risk reduction could be reached. Nevertheless, most of the publications also showed that the preferences of AF patients towards OACs may differ from the perspective of clinical guidelines or the perspective of physicians. The remaining 11 studies included in our review assessed the preferences of AF patients towards specific OAC medication options, namely NOACs versus VKAs. Our review showed that AF patients prefer easy-to-administer treatments, such as treatments that are applied once daily without any food/drug interactions and without the need for bridging and frequent blood controls. Conclusion Stroke risk reduction and a moderate increase in the risk of bleeding are the most important attributes for an AF patient when deciding whether they are for or against OAC treatment. If different anticoagulation options have similar clinical characteristics, convenience attributes matter to patients. In this review, AF patients favour attribute levels that describe NOAC treatment.

Background Standard treatment for venous thromboembolism (VTE) consists of a heparin combined with vitamin K antagonists. Direct oral anticoagulants have been investigated for acute and extended treatment of symptomatic VTE; their use could avoid parenteral treatment and/or laboratory monitoring of anticoagulant effects. Methods A prespecified pooled analysis of the EINSTEIN-DVT and EINSTEIN-PE studies compared the efficacy and safety of rivaroxaban (15 mg twice-daily for 21 days, followed by 20 mg once-daily) with standard-therapy (enoxaparin 1.0 mg/kg twice-daily and warfarin or acenocoumarol). Patients were treated for 3, 6, or 12 months and followed for suspected recurrent VTE and bleeding. The prespecified noninferiority margin was 1.75. Results A total of 8282 patients were enrolled; 4151 received rivaroxaban and 4131 received standard-therapy. The primary efficacy outcome occurred in 86 (2.1%) rivaroxaban-treated patients compared with 95 (2.3%) standard-therapy-treated patients (hazard ratio, 0.89; 95% confidence interval [CI], 0.66–1.19; p noninferiority  < 0.001). Major bleeding was observed in 40 (1.0%) and 72 (1.7%) patients in the rivaroxaban and standard-therapy groups, respectively (hazard ratio, 0.54; 95% CI, 0.37–0.79; p = 0.002). In key subgroups, including fragile patients, cancer patients, patients presenting with large clots, and those with a history of recurrent VTE, the efficacy and safety of rivaroxaban were similar compared with standard-therapy. Conclusion The single-drug approach with rivaroxaban resulted in similar efficacy to standard-therapy and was associated with a significantly lower rate of major bleeding. Efficacy and safety results were consistent among key patient subgroups. Trial registration EINSTEIN-PE: ClinicalTrials.gov, NCT00439777 ; EINSTEIN-DVT: ClinicalTrials.gov, NCT00440193 .

To determine characteristics and clinical outcomes of German patients with coronary artery disease (CAD) with or without peripheral artery disease (PAD) who initiated dual pathway inhibition (DPI) using rivaroxaban 2.5 mg twice daily plus aspirin 100 mg once daily in clinical practice in Germany and to compare those with the results for CAD patients of the COMPASS trial. XATOA was an international prospective registry with a mean follow-up period of 15 months. There were 1641 German CAD patients included, of which 747 patients (45.5%) had CAD only and 894 patients (54.5%) had both CAD and PAD. Baseline characteristics (age, sex, medical history, prior medications) were similar between the subgroups of German CAD patients and comparable to CAD patients of COMPASS. The incidence of major adverse cardiovascular events (MACE) was comparable between CAD patient subgroups of XATOA Germany (only CAD patients: 3.7%, CAD + PAD patients: 3.9%) and was similar to the incidence for CAD patients overall in XATOA and in COMPASS (All CAD patients XATOA: 3.8% vs. 4.2% COMPASS CAD). Incidence for major bleeding was markedly lower in CAD patients of XATOA Germany compared to COMPASS CAD patients (All CAD patients XATOA: 1.1% vs. 3.2% in COMPASS CAD). In this real world experience among German patients with CAD enrolled in XATOA, DPI with rivaroxaban and aspirin was associated with low incidence of MACE and major bleeding.

Background The Clopidogrel and Acetylsalicylic Acid in Bypass Surgery for Peripheral Arterial Disease (CASPAR) trial is the only large, double‐blind, placebo‐controlled trial of dual antiplatelet therapy (DAPT) versus aspirin in patients with peripheral artery disease (PAD) after lower extremity revascularization (LER). The trial was neutral for index‐graft occlusion/revascularization, amputation or death (hazard ratio [HR] 0.98, 95% confidence interval [CI] 0.78–1.23, p = .87) with an excess of global utilization of streptokinase and tissue plasminogen activator for occluded coronary arteries moderate or severe bleeding (HR 2.84, 95% CI 1.32–6.08, p = .007). Hypothesis and Methods VOYAGER‐PAD demonstrated that rivaroxaban significantly reduces acute limb ischemia (ALI), major amputation, myocardial infarction (MI), stroke and CV death but increased bleeding. The relative efficacy and safety of rivaroxaban in a CASPAR like population and for similar outcomes is unknown. The current analysis is a post‐hoc exploratory analysis of a “CASPAR like” composite of ALI, unplanned index limb revascularization (UILR), amputation or CV death in surgical patients. Results In the 2185 who underwent surgical LER, rivaroxaban reduced the CASPAR endpoint at 1 (HR 0.76, 95% CI 0.62−0.95, p = .0133) and 3 years (HR 0.84, 95% CI 0.71−1.00, p = .0461, Figure). There were similar reductions in composites of ALI, amputation or CV death (HR 0.79, p = .0228) and ALI, UILR, amputation, MI, IS or CV death (HR 0.85, p = .0410). Conclusions The combination of rivaroxaban and aspirin significantly reduces ischemic outcomes in patients with PAD after LER. Although no formal head‐to‐head comparison exists, in a similar population and for similar outcomes, this regimen demonstrated benefit where trials of DAPT were neutral. These data suggest that factor Xa inhibition may provide specific benefits in this population and that DAPT should not be considered a proven substitution.