78 research outputs found
Nurse-led care vs. usual care for patients with atrial fibrillation: results of a randomized trial of integrated chronic care vs. routine clinical care in ambulatory patients with atrial fibrillation
No full textCorrigendum: The Clinicaltrials.gov identifier number in the abstract of this article should have read NCT00753259 not NCT00391872. Please see: http://dx.doi.org/10.1093/eurheartj/ehs447AIMS: The management of patients with atrial fibrillation (AF) is often inadequate due to deficient adherence to the guidelines. A nurse-led AF clinic providing integrated chronic care to improve guideline adherence and activate patients in their role, may effectively reduce morbidity and mortality but such care has not been tested in a large randomized trial. Therefore, we performed a randomized clinical trial to compare the AF clinic with routine clinical care in patients with AF. METHODS AND RESULTS: We randomly assigned 712 patients with AF to nurse-led care and usual care. Nurse-led care consisted of guidelines based, software supported integrated chronic care supervised by a cardiologist. The primary endpoint was a composite of cardiovascular hospitalization and cardiovascular death. Duration of follow-up was at least 12 months. Adherence to guideline recommendations was significantly better in the nurse-led care group. After a mean of 22 months, the primary endpoint occurred in 14.3% of 356 patients of the nurse-led care group compared with 20.8% of 356 patients receiving usual care [hazard ratio: 0.65; 95% confidence interval (CI) 0.45-0.93; P= 0.017]. Cardiovascular death occurred in 1.1% in the nurse-led care vs. 3.9% in the usual care group (hazard ratio: 0.28; 95% CI: 0.09-0.85; P= 0.025). Cardiovascular hospitalization amounted (13.5 vs. 19.1%, respectively, hazard ratio: 0.66; 95% CI: 0.46-0.96, P= 0.029). CONCLUSION: Nurse-led care of patients with AF is superior to usual care provided by a cardiologist in terms of cardiovascular hospitalizations and cardiovascular mortality. Trial registration information: Clinicaltrials.gov identifier number: NCT00391872.Jeroen M.L. Hendriks, Rianne de Wit, Harry J.G.M. Crijns, Hubertus J.M. Vrijhoef, Martin H. Prins, Ron Pisters, Laurent A.F.G. Pison, Yuri Blaauw, Robert G. Tielema
Cardiac tachyarrhythmias and patient values and preferences for their management: The European Heart Rhythm Association (EHRA) consensus document endorsed by the Heart Rhythm Society (HRS), Asia Pacific Heart Rhythm Society (APHRS), and Sociedad Latinoamericana de Estimulación Cardíaca y Electrofisiología (SOLEACE)
No full textN/
Treatment of venous thromboembolism with rivaroxaban in relation to body weight A sub-analysis of the EINSTEIN DVT/PE studies
No full textThe pharmacokinetics of oral rivaroxaban are highly predictable and only affected to a limited extent by bodyweight; therefore, dose adjustments for bodyweight are not required. However, this raises concerns among physicians for potential under- or overdosing. This substudy of the randomised EINSTEIN DVT and EINSTEIN PE trials, which compared rivaroxaban with enoxaparin/vitamin K antagonist (VKA) therapy, aimed to determine the incidence of major bleeding in patients with a low bodyweight and recurrent venous thromboembolism (VTE) in patients with a high bodyweight during rivaroxaban or enoxaparin/VKA therapy. More than 8,000 patients with objectively diagnosed deep vein thrombosis or pulmonary embolism were included. Adjusted hazard ratios for recurrent VTE and bleeding were calculated using the Cox proportional hazards model. Analyses were performed for both the first 21 days of treatment and the whole treatment period. For rivaroxaban recipients, there was no association between bodyweight or body mass index (BMI) and risk of recurrent VTE (p(trend)=0.87 and 0.62, respectively), major bleeding (p(trend)=0.24 and 0.36, respectively) or clinically relevant bleeding (p(trend)=0.17 and 0.63, respectively). Major bleeding events were numerically lower in rivaroxaban patients across all body weight and BMI categories. Hazard ratios for rivaroxaban vs enoxaparin/VKA were similar in all bodyweight and BMI categories, both during the first 21 days and the whole treatment period. The fixed-dose rivaroxaban regimen is not associated with an increased risk of major bleeding or recurrent VTE in patients with either a low or high body weight. A high BMI was not associated with an increased risk of recurrent VTE during anticoagulation
Net clinical benefit of edoxaban for stroke, mortality, and bleeding risk:Modeling Projections for a European population
No full textObjectives The purpose of this study was to determine, in a model based on Europeans at risk of stroke by virtue of atrial fibrillation (AF), the net clinical benefit of edoxaban in the reduction of the risk of stroke, mortality, and of hemorrhage. Background Vitamin K antagonists (e.g., warfarin) are commonly underused because of such factors as fear of hemorrhage in patients with high-risk AF. The non-vitamin K antagonist oral anticoagulants are similarly or more effective than warfarin and have lower rates of serious hemorrhage. Although outcomes of the ENGAGE AF-TIMI 48 trial that compared the non-vitamin K antagonist oral anticoagulant edoxaban with warfarin and indicated similar efficacy and better safety compared with warfarin for stroke prevention in AF, the application of trial data to the general population is unknown. Methods This study modelled a treatment effect of edoxaban on the risks of thromboembolism, major bleeding, and death in a real-world population of patients with AF drawn from the Euro Heart Survey, and extrapolated this to the general European population. Results In those at high risk of stroke (CHA2DS2VASc ≥2), edoxaban would need to be taken by 319 patients to prevent 1 thromboembolism, major bleeding event, or death compared with warfarin, and by 41 patients to prevent 1 thromboembolism or death compared with no treatment. These translate to demonstrating a net clinical benefit of 8.9 events saved per 1,000 patients with edoxaban 60 mg. Modeling these data to the population of Europe of 508 million, use of edoxaban 30 mg and 60 mg instead of warfarin would, respectively, prevent approximately 19,400 and 30,300 thromboembolic events, major bleeds, and deaths annually. Conclusions Our modeling exercise suggests that the use of edoxaban for thromboprophylaxis in AF based on current guidelines could provide a profound benefit on rates of stroke, major bleeds, and deaths in European patients with AF.</p
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